A Prospective Multi-center Study to Evaluate Clinical Equivalence (Method Comparison) Between the BD MiniDraw™ SST™ Capillary Blood Collection Tube and BD MiniDraw™ EDTA Capillary Blood Collection Tube to Respective Comparators
Conditions: Healthy, Disease, Chronic, Acute Disease, Sample Collection
Sponsor: Becton, Dickinson and Company

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 1 of 67 
 
TITLE PAGE 
 
Protocol Title:  
A prospective multi-center study to evaluate clinical equivalence (method comparison) between 
the BD Microtainer® Easy Collect Capillary Tube SST™ and BD Microtainer® Easy Collect 
Capillary Tube EDTA devices to respective comparators 
 
Protocol Number: 
 
 
Version Number: 4.0 
 
Study Device: 
 
 Tube SST™ 
 
 
 EDTA  
 
Study Type:  
Investigational Device Exemption (IDE)  
 
Short Title:  
 
 
 
Sponsor Name: BD Integrated Diagnostic Solutions 
 
Legal Registered Address: 1 Becton Drive; Franklin Lakes, NJ 07417 
Sponsor Contact: 
Nathan Loes 
Sr. Clinical Project Manager 
Nathan.Loes@BD.com 
 
Regulatory Agency Identifier Number(s): Not applicable 
National Principal Investigators 
 
 
 
 
 
 
 
 
Becton Dickinson and Company 
1 Becton Drive  
Franklin Lakes, NJ 07417 
Vice President, Global Clinical Development 
 
 
 
 
 
 
 
 
 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 2 of 67 
 
Version History: 
 
Version Number 
Date 
Type 
1.0 
12/20/2021 
Original 
2.0 
02/22/2022 
Amendment  
3.0 
06/06/2022 
Protocol updated to include interim analysis (Section 
10.6).  Sponsor Contact and team members/approvers 
were updated.  Adverse Event (Section 9.1.1.) was 
updated to be consistent with changes being made to 
subsequent 
 protocols 
4.0 
09/07/2022 
Protocol Updated to specify which Instrument Flags 
will be evaluated (Section 1.1 Protocol Synopsis pg 
11; Section 3 Objectives & Endpoints pgs 23-24). 
Table 3 – Reference numbers for Vitamin D 
(10995719/10995720) & Total Protein (11097604) 
were updated to reflect the correct assay reference 
numbers used in the study.  Previous Reference 
number for Vitamin D (11201772/11201773) was an 
invalid reference and Total Protein (11097524) is for 
urine analysis which were listed in error in the 
protocol. 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 3 of 67 
 
SPONSOR PROTOCOL APPROVAL 
 
Signature below indicates approval of the protocol as written. 
Individual or 
function 
Name 
Signature 
Date 
 
 
 
 
 
This document is 
signed electronically 
in the eTMF system 
 
 
 
 
 
 
This document is 
signed electronically 
in the eTMF system 
 
 
 
 
 
 
This document is 
signed electronically 
in the eTMF system 
 
 
 
 
 
This document is 
signed electronically 
in the eTMF system 
 
 
 
 
 
 
 
This document is 
signed electronically 
in the eTMF system 
 
 
 
 
 
 
This document is 
signed electronically 
in the eTMF system 
 
 
 
 
 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 4 of 67 
 
PRINCIPAL INVESTIGATOR AGREEMENT PAGE 
 
Investigator Responsibilities 
 
1. Prior to participation in this study, the Investigator or Institution must sign the Clinical 
Study Agreement (CSA) and obtain written approval from the appropriate Institutional 
Review Board (IRB)/Ethics Committee (EC). 
2. The Investigator must receive BD-sponsored training prior to site activation. The 
Investigator is responsible for ensuring that all Sub-Investigators and clinical staff are 
adequately trained prior to performing any data collection or study-related procedures.   
3. The Principal Investigator shall ensure that the study is conducted in accordance with the 
study protocol, any modifications as requested by the IRB/EC, the signed CSA, the ethical 
principles of the Declaration of Helsinki, Good Clinical Practice (ICH E6) / ISO 14155), 
and applicable national/regional regulations and laws. 
4. If applicable, ensure that written informed consent is obtained from each participant prior 
to the conduct of any study procedure, using the current IRB/EC approved Informed 
Consent Form. 
 
 
I have read and understand the contents of this study protocol. I agree to follow and abide by the 
requirements set forth in this document. I agree to conduct the trial in accordance with 
the study protocol, the signed Clinical Study Agreement, and Good Clinical Practice (GCP) as 
well as applicable FDA and ISO regulations (e.g., 21 CFR Parts 812, 50, 54, 56; ISO 
14155:2011E). I agree to participate in BD-Sponsored training prior to performing any data 
collection or study-related procedures. 
 
 
Agreed to by (Investigator):  
  
_______________________________________________  
Printed Name – Investigator   
  
_______________________________________________  
Signature – Investigator  
 
_______________________________________________  
 Site Number 
 
_______________________________________________  
Date  
 
 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 5 of 67 
 
TITLE PAGE .................................................................................................................................. 1 
Abbreviations .................................................................................................................................. 8 
1 
PROTOCOL SUMMARY ...................................................................................................... 9 
1.1 
Synopsis ........................................................................................................................... 9 
1.2 
Schema ........................................................................................................................... 17 
2 
INTRODUCTION ................................................................................................................ 18 
2.1 
Rationale......................................................................................................................... 19 
2.2 
Risk/Benefit Assessment ................................................................................................ 19 
2.2.1 
Risk Assessment ..................................................................................................... 19 
2.2.2 
Benefit Assessment ................................................................................................. 21 
2.2.3 
Overall Benefit: Risk Conclusion ........................................................................... 21 
3 
OBJECTIVES AND ENDPOINTS ...................................................................................... 21 
3.1 
Acceptance Criteria ........................................................................................................ 22 
4 
STUDY DESIGN.................................................................................................................. 25 
4.1 
Overall Design................................................................................................................ 25 
4.2 
Scientific Rationale for Study Design ............................................................................ 26 
4.2.1 
Participant Input into Design .................................................................................. 26 
4.3 
End of Study Definition ................................................................................................. 26 
5 
STUDY POPULATION ....................................................................................................... 26 
5.1 
Inclusion Criteria ............................................................................................................ 27 
5.2 
Exclusion Criteria ........................................................................................................... 27 
5.3 
Lifestyle Considerations ................................................................................................. 28 
5.4 
Screen Failures ............................................................................................................... 28 
6 
STUDY INTERVENTIONS .............................................................................................. 28 
6.1 
Investigational/Test Device ............................................................................................ 28 
6.2 
Comparator Devices/Standard of Care ........................................................................... 29 
6.3 
Ancillary Devices/Products ............................................................................................ 29 
6.4 
Device Labeling ............................................................................................................. 30 
6.5 
Measures to Minimize Bias ............................................................................................ 30 
6.5.1 
Randomization ........................................................................................................ 30 
6.5.2 
Blinding/Masking ................................................................................................... 30 
7 
STUDY PROCEDURES AND ASSESSMENTS ................................................................ 30 
7.1 
Screening, Informed Consent, and Enrollment .............................................................. 31 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 6 of 67 
 
7.2 
Blood Collection Procedure ......................................................................................... 31 
7.3 
Test Device Blood Collection Procedure ....................................................................... 32 
7.4 
Repeat Collection ........................................................................................................... 36 
7.5 
Participant Compensation .............................................................................................. 37 
7.6 
Natural and Contrived Sample Storage and Processing ................................................. 37 
7.7 
Supplemental Measurements, Visual Observations, and Analyte Testing..................... 39 
7.7.1 
Part A: SERUM (Natural and Contrived Samples) ................................................ 41 
7.7.2 
Part B: EDTA .......................................................................................................... 43 
7.8 
Natural and Contrived Sample Acceptance and Rejection Criteria for Analyte Testing 46 
7.9 
Repeat Testing Natural and Contrived Samples ............................................................ 46 
7.10 Residual Sample Usage (Natural Sample Group Only) ................................................. 47 
7.11 Safety Evaluations .......................................................................................................... 48 
8 
PARTICIPANT DISCONTINUATION/WITHDRAWAL.................................................. 48 
8.1 
Discontinuation/Withdrawal .......................................................................................... 48 
8.2 
Lost to Follow-Up .......................................................................................................... 49 
9 
ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................... 49 
9.1 
Definitions of Events ...................................................................................................... 49 
9.1.1 
Adverse Events (AEs) ............................................................................................. 49 
9.1.2 
Serious Adverse Events (SAEs).............................................................................. 50 
9.1.3 
Adverse Device Effect (ADE) / Serious Adverse Device Effect (SADE) .............. 50 
9.1.4 
Unanticipated (Serious) Adverse Device Effect (UADE/USADE) ........................ 50 
9.2 
Severity of Adverse Events ............................................................................................ 51 
9.3 
Relationship of Adverse Event to Device(s)/Procedure ................................................. 51 
9.4 
Reporting of Events ........................................................................................................ 52 
9.5 
Safety Committees ......................................................................................................... 52 
9.6 
Device Deficiencies........................................................................................................ 52 
10 STATISTICAL METHODS ................................................................................................. 53 
10.1 Overview of Study Design ............................................................................................. 53 
10.2 Sample Size Considerations ........................................................................................... 53 
10.3 Analysis Population........................................................................................................ 53 
10.4 General Considerations .................................................................................................. 54 
10.5 Analysis Methods ........................................................................................................... 55 
10.5.1 Clinical Equivalence Endpoints .............................................................................. 55 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 7 of 67 
 
10.5.2 Visual Observations and Supplemental Measurements Endpoints ......................... 55 
10.5.3 Safety Analysis Endpoints ...................................................................................... 55 
10.6 Interim Analysis ............................................................................................................. 55 
11 DATA COLLECTION AND RECORD MAINTENANCE ................................................ 56 
11.1 Case Report Forms ......................................................................................................... 56 
11.2 Source Documentation ................................................................................................... 56 
11.3 Data Management .......................................................................................................... 56 
11.4 Record Retention ............................................................................................................ 57 
12 QUALITY CONTROL AND ASSURANCE ...................................................................... 57 
12.1 Control of Study Products .............................................................................................. 57 
12.2 Monitoring ...................................................................................................................... 57 
12.3 Audits and Inspections ................................................................................................... 58 
12.4 Protocol Deviations ........................................................................................................ 58 
12.4.1 Occurrence of Special Interest ................................................................................ 59 
13 ADMINISTRATIVE REQUIREMENTS ............................................................................ 59 
13.1 Investigator and Site Selection ....................................................................................... 59 
13.2 Training .......................................................................................................................... 60 
13.3 Required Documents ...................................................................................................... 60 
13.4 Publication Policy .......................................................................................................... 60 
13.5 Study Registration .......................................................................................................... 61 
13.6 Termination of Study ..................................................................................................... 61 
14 ETHICAL AND REGULATORY CONSIDERATIONS .................................................... 61 
14.1 IRB/EC Approval ........................................................................................................... 61 
14.2 Informed Consent and Confidentiality (Natural Samples) ............................................. 61 
14.2.1 Confidentiality ........................................................................................................ 62 
14.3 Regulatory Status ........................................................................................................... 62 
14.4 Statement of Compliance ............................................................................................... 63 
15 REFERENCES ..................................................................................................................... 64 
16 APPENDICES ...................................................................................................................... 65 
 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 8 of 67 
 
Abbreviations 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AMR 
Analytical Measurement Range 
BD 
Becton, Dickinson, and Company 
CAL 
Clinical Acceptance Limits 
CAP 
Capillary Collection 
CBC 
Complete Blood Count 
CFR 
Code of Federal Regulations 
CI 
Confidence Interval 
COV 
Close-out Visit 
CRF 
Case Report/Record Form 
CSA 
Clinical Study Agreement 
CV 
Coefficient of Variation 
DMP 
Data Management Plan 
EDC 
Electronic Data Capture 
EDTA 
Ethylenediaminetetraacetic acid 
FDA 
Food and Drug Administration 
FDAAA 
FDA Amendments Act of 2007 
GCP 
Good Clinical Practice 
HbA1c 
Hemoglobin A1c (glycosylated hemoglobin) 
HIPAA  
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IDE 
Investigational Device Exemption 
IDS-SM 
Integrated Diagnostic Solutions – Specimen Management  
IFU 
Instructions for Use 
IP 
Interpretive Program 
IRB/EC 
Institutional or Independent Review Board/Ethics Committee 
ISO 
International Organization for Standardization 
IUO 
Investigational Use Only 
MDL 
Medical Decision Levels 
NDA 
Nondisclosure Agreement 
OSI 
Occurrence of Special Interest 
PFH 
Plasma Free Hemoglobin 
PI 
Principal Investigator 
RMV 
Routine Monitoring Visit 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
SIV 
Site Initiation Visit 
SOP 
Standard Operating Procedure 
SST™ 
Serum Separator Tube 
UADE 
Unexpected Adverse Device Effect 
US 
United States 
USADE 
Unexpected Serious Adverse Device Effect 
VP 
Venipuncture 
WHO 
World Health Organization 
 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 9 of 67 
 
1 
PROTOCOL SUMMARY 
 
1.1 
Synopsis 
Protocol Title 
A prospective multi-center study to evaluate clinical equivalence 
(method comparison) between the B
 
 
 Tube SST™ and 
 
 Capillary 
Tube EDTA devices to respective comparators  
Short Title 
 Capillary System Clinical Equivalence 
Study 
Rationale 
 
 The 
study is intended to assess clinical equivalence (method comparison) of 
the 
 Tube SST™ and 
 
 Tube EDTA to the respective 
comparators (listed below) 
. 
Part A: 
 Tube SST™ versus 
Comparator product(s): 
• 
® SST™ Blood Collection Tube 
 
SST) 
• 
 SST™ Blood Collection Tube 
 
SST) 
• 
 Tube with Clot Activator 
and Gel Separator 
 
 
Part B: 
 Tube EDTA versus 
Comparator product(s): 
• 
 
EDTA)  
• 
 
EDTA) 
• 
tube with K2EDTA 
 
 
Objectives and Endpoints 
 
Objectives and endpoints of this study are provided below.  
Objectives 
Endpoints 
Clinical Equivalence 
SERUM 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 10 of 67 
 
Protocol Title 
A prospective multi-center study to evaluate clinical equivalence 
(method comparison) between the 
 
 
 Tube SST™ and 
 
 
Tube EDTA devices to respective comparators  
To demonstrate clinical 
equivalence of the 
 
 
 Tube SST™ (Test 
Device SST) as compared to 
the relevant comparators for 
chemistry analytes listed in 
Table 3. 
Average difference between Test 
Device SST and respective 
comparator device. 
• 
Test Device SST vs. 
 
 Serum (Venous 
Comparator) 
• 
Test Device SST vs. 
 
 SST (Capillary 
Comparator) 
EDTA 
To demonstrate clinical 
equivalence of the 
 
 
 Tube EDTA (Test 
Device EDTA) as compared 
to the relevant comparators for 
whole blood parameters listed 
in Table 5. 
Average difference between 
investigational device and respective 
comparator device. 
• 
Test Device EDTA vs. 
 
 EDTA (Capillary 
Comparator) 
• 
Test Device EDTA vs. 
 EDTA 
(Venous Comparator) 
 
Visual Observations and Supplemental Measurements: SERUM 
Evaluation of the frequency of 
selected visual observations in 
the 
 
 Tube SST™ 
(Test Device SST) and all 
comparator tube types: 
• 
 SST 
• 
 SST 
• 
 
Serum 
Frequency of selected visual 
observations. 
To evaluate sample hemolysis 
as measured by Plasma Free 
Hemoglobin (PFH) for 
 
 
Mean and distribution of PFH values 
per tube type and frequency of PFH 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 11 of 67 
 
Protocol Title 
A prospective multi-center study to evaluate clinical equivalence 
(method comparison) between the 
 
 
 Tube SST™ and 
 
 
Tube EDTA devices to respective comparators  
 Tube 
 and 
comparators using the 
Siemens Atellica platform. 
occurrence above 50mg/dL per tube 
type. 
To evaluate serum collection 
volume of the
 
 
 (Test 
Device 
 tube).  
Serum collection volume as 
measured by the weight of serum in 
the 
 
 
To evaluate duration of 
sample collection for the 
 
 
(Test 
Device 
 tube) and 
capillary comparator. 
Mean time in seconds between 
puncture timestamp and additive/ 
blood mix start timestamp per tube 
type. 
Visual Observations and Supplemental Measurements: EDTA 
Evaluation of the frequency of 
visual observations in the 
 
 
 (Test 
Device EDTA tube) and all 
comparator tube types: 
• 
 
EDTA 
• 
 EDTA 
• 
 EDTA 
Frequency of selected visual 
observations. 
Evaluation of the frequency of 
occurrence of instrument flags 
(both asterisks and IP 
messages of interest) in the 
 
 Tube EDTA 
(Test Device EDTA) and all 
comparator tube types. 
 
Frequency of occurrence of 
instrument flags. Confirmation of 
relevant flags by manual review of 
smears. 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 12 of 67 
 
Protocol Title 
A prospective multi-center study to evaluate clinical equivalence 
(method comparison) between the 
 
 
 Tube SST™ and 
 
 
Tube EDTA devices to respective comparators  
version 1.0 for instrument 
flags of interest. 
To evaluate peripheral blood 
smears for samples with 
platelet clump instrument IP 
messages. 
• 
Frequency of occurrence of 
platelet clump instrument flags, 
confirmed by peripheral smear 
review.  
• 
Frequency of instrument platelet 
clump flags with no platelet 
clumps identified on peripheral 
smear. 
To evaluate whole blood 
collection volume for the 
 
 
 Tube EDTA (Test 
Device EDTA). 
Whole blood collection volume as 
measured by the weight of whole 
blood in the Test Device EDTA tube 
after collection. 
To evaluate duration of 
sample collection for the 
 
 
 Tube EDTA (Test 
Device EDTA) and capillary 
comparator. 
Mean time in seconds between 
puncture timestamp and 
additive/blood mix start timestamp 
per tube type. 
Device Safety Assessment 
To assess the safety of the 
Test Device SST and EDTA 
systems. 
Device/procedure - related adverse 
events (AEs). 
For Informational Purposes Only:  
SERUM 
Evaluate clinical equivalence 
between comparator tubes for 
the chemistry analytes listed 
in Table 3. 
Average difference for tube 
comparisons. 
• 
Test Device SST tube vs. 
 SST tube 
(Venous Comparator) 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 13 of 67 
 
Protocol Title 
A prospective multi-center study to evaluate clinical equivalence 
(method comparison) between the 
 
 
 Tube SST™ and 
 
 
Tube EDTA devices to respective comparators  
• 
 vs. 
 Serum 
• 
 SST vs. BD 
SST tube 
• 
 SST tube vs. 
 Serum 
EDTA 
Evaluate clinical equivalence 
between comparator tubes for 
all analytes listed in Table 5. 
Average difference between the 
following devices 
• 
Test Device EDTA tube vs. 
 EDTA 
• 
 vs. 
 
 EDTA 
• 
 EDTA vs. 
 
 EDTA. 
• 
 EDTA vs. 
 EDTA 
Design and Overview 
This is a prospective, multi-center study designed to evaluate the safety 
and effectiveness of the 
 Tube 
SST™ and 
 Tube EDTA 
devices. 
This study will be conducted in two parts; Part A will evaluate the 
 
 Tube 
 device and Part B 
will evaluate the 
 Tube EDTA 
device.  A minimum of 100 participants, and a maximum of 150 
participants per part will be enrolled at a minimum of three various 
 site settings representative of the intended use 
environment 
 
  
Samples will be collected by 
 
 
 
. Comparator venous and conventional capillary tubes will 
be collected by Phlebotomists. Samples will be collected, clotted 
- Protocol | 

Protocol Number: 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
Page 14 of 67 
Protocol Title 
A prospective multi-center study to evaluate clinical equivalence 
(method comparison) between the 
 Tube SST™ and 
Tube EDTA devices to respective comparators 
(serum samples only) and centrifuged within 2 hours of collection 
(serum samples only) prior to testing, within 4 hours of collection (see 
Section 7).  
The study population will include apparently healthy participants and 
patient populations ≥18 years of age, covering a range of disease states 
(See Section 5). The goal is to maximize coverage of the assay 
measurable range for each analyte, including above and below medical 
decision levels and at the extremes of the range, with natural samples 
where possible. 
Approximately 10 % contrived samples will be prepared for each 
analyte to cover the assay measurable range (AMR). Preparation of 
these samples will be described under a separate Spiking Plan. An 
overview of the spiking approach is provided in Appendix B. 
Study Device 
, Investigational 
Use Only (IUO) 
The BD Microtainer® Easy Collect Capillary Tube SST™ is a part of 
the prototype capillary collection device system that includes a capillary 
blood collection container with clot activator.  Additional details are 
provided in Section 6.1 
 Tube EDTA, Investigational 
Use Only (IUO) 
 Tube EDTA is 
blood container with K2EDTA anticoagulant. 
Participants 
•
Participants will fall under two groups: Natural Sample Group
(uncontrived) and Contrived Sample Group. The Contrived Sample
Group of participants will be enrolled
. The collection of blood, and 
preparation of the contrived samples from the blood collected from 
these subjects is outlined in the overview presented in Appendix B. 
Detailed instructions will be provided in a separate Spiking Plan. 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 15 of 67 
 
Protocol Title 
A prospective multi-center study to evaluate clinical equivalence 
(method comparison) between the 
 
 
 Tube SST™ and 
 
 
Tube EDTA devices to respective comparators  
• 
Participants ≥18 years of age recruited 
 
 in-person, via phone, or 
via electronic communications using IRB-approved recruitment 
materials.  In order to cover the assay measurable range (AMR) 
additional in- and out-patient hospital populations with disease 
states such as the below listed conditions may be enrolled. 
• 
Part A: Patients with hepatic, renal, endocrine, cardiovascular 
disorders and/or cancer. 
• 
Part B: Patients with hematological disorders, cancers, diabetes 
and/or allergies. 
Intervention(s)/Procedure(s) After completing the informed consent process and enrolling into the 
study, blood will be collected from participants using a predetermined 
randomization schedule which will include randomized collection type 
(venous or capillary) and tube draw order.  
Participants in study Part A will have 
 collections 
performed using the Test Device SST, and two (2) conventional 
 collections performed using the currently marketed 
 
 
 device. A standard venipuncture will also be 
performed to collect samples into 
 
 
 comparator tubes. An approximate blood volume of 
10 mL will be collected from participants in Part A.  
Participants in study Part B will have 
 collection 
performed using the Test Device EDTA and 
 conventional 
 collection 
. A standard venipuncture 
will also be performed to collect samples into the 
 
EDTA and 
 
 EDTA comparator tubes. An 
approximate blood volume of 5 mL will be collected from participants 
in Part B. 
Samples will be mixed and processed per their respective IFUs.  
Samples will be transported to 
 laboratory for analysis within 
4 hours of collection end time for serum tubes and within 4 hours of 
collection end time for EDTA tubes. The collection end time 
(additive/blood mix start timestamp) for each conventional and Test 
Device capillary tube collected from a participant will be noted on the 
CRF. For venous collections, the collection end time (additive/blood 
mix start timestamp) will be the time of the last tube collected 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 16 of 67 
 
Protocol Title 
A prospective multi-center study to evaluate clinical equivalence 
(method comparison) between the 
 
 
 Tube SST™ and 
 
 
Tube EDTA devices to respective comparators  
. Analysis time is defined as the time at which the 
sample is aspirated by the instrument.  
Investigational Sites 
This study will be conducted at a minimum of 3 sites in the US.  
 
 
 
Data Monitoring Committee Not applicable 
Regulatory Status 
IDE Exempt  
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 17 of 67 
 
1.2 
Schema 
 
Natural Sample Group 
Part A 
Part B 
-- Protocol 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 18 of 67 
 
Contrived Sample Group 
A Schema which provides an overview of the spiking approach is presented in Appendix B. 
Details of the collection of blood and preparation of the contrived samples will be provided 
in a separate Spiking Plan. 
 
2 
INTRODUCTION 
 
BD Integrated Diagnostic Solutions – Specimen Management (IDS-SM) manufactures a 
range of tubes 
 
for clinical testing.   
 
Currently, the method for collection of a large volume of capillary blood (up to 600 µL) 
involves optional warming of the hand or finger prior to procedure, lancing of the fingertip, 
squeezing the fingertip by hand, and dripping the blood into an open non-sterile tube. The 
capillary blood collection process is considered cumbersome and lacks standardization in 
how much pressure is applied in squeezing of the finger which may lead to poor sample 
quality or insufficient blood volume. Common sample quality issues for capillary blood 
collection include hemolysis and dilution of sample with interstitial fluid, potentially causing 
bias in test results. Open collection also carries a risk of blood exposure for healthcare 
workers and potential risk of infection at the finger puncture site.  
 
 
 
 
 
 
 
 
  
 
 
  
 
 
  
 
 
 
  
 
 
 
   
 
 
 
 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 19 of 67 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
2.1 
Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2.2 
Risk/Benefit Assessment 
 
This study provides no direct health benefit to the participants but is associated with minimal 
risk.  The risks to participants are in line with standard blood collection procedures. 
 
More detailed information about the known and expected benefits and risks and reasonably 
expected adverse events of capillary blood collection may be found in the IFU. 
 
 
 
 
 
2.2.1 Risk Assessment 
 
Potential Risk of Clinical 
Significance 
Summary of 
Data/Rationale for 
Risk 
Mitigation Strategy 
Study Intervention: 
 
 
• Since the 
 blood 
collection tubes may contain 
Package insert 
• Venipuncture will be performed 
using commercially available sterile 
evacuated blood collection tubes 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 20 of 67 
 
Potential Risk of Clinical 
Significance 
Summary of 
Data/Rationale for 
Risk 
Mitigation Strategy 
chemical additives, backflow 
may cause adverse reactions. 
 
• There is a risk of blood exposure 
for study staff should a study 
tube leak or break. 
following standard venipuncture 
procedure and best practices for 
venipuncture. During the 
venipuncture procedure the 
participant’s arm will be placed in a 
downward position; tubes will be 
held with the stopper uppermost; The 
tourniquet should be released as soon 
as blood starts to flow; and care is 
taken to make sure the additives do 
not touch the stopper or end of the 
needle during venipuncture 
• Study staff will use 
Universal/Standard Precautions 
during all procedures where exposure 
to blood/blood components may be 
possible. 
Study Procedures: Blood Specimen Collection 
Blood collection by venipuncture 
is known to be associated with:  
• Slight/moderate discomfort at 
the collection site 
• Bruising/hematoma 
• Scarring 
• Infection 
• Syncope 
• Nausea/vomiting   
Common medical 
knowledge; package 
insert 
• Venipuncture will be performed by 
phlebotomists. 
• Venipuncture will be performed at a 
location with sufficient medical 
facilities by phlebotomists to ensure 
participant safety and comfort. 
Capillary blood collection using 
non-sterile collection tube and 
finger device (if applicable) may 
have a risk of non-sterile surfaces 
touching skin at the puncture site 
leading to a potential risk of 
infection 
 
 
Instruction for use; 
package insert 
• Disinfection of the finger puncture 
site and the interior surface of the 
finger device, that is in contact with 
the finger, with disposable alcohol 
wipe will be performed prior to 
capillary collections 
• 
 
 
 
 will be 
instructed to follow universal 
precautions/risk mitigation 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 21 of 67 
 
Potential Risk of Clinical 
Significance 
Summary of 
Data/Rationale for 
Risk 
Mitigation Strategy 
procedures to minimize blood 
exposure. 
• New devices will be used for each 
individual 
 collection. 
• The 
 device will be disinfected 
prior to use 
• The skin at the puncture site will be 
disinfected prior to collection. 
• The 
 tool is 
 
 and will be discarded after each 
participant use. 
Other 
Discomfort during capillary blood 
collection  
Common medical 
knowledge 
• Devices will be removed 
immediately upon participant 
request due to pain or discomfort. 
• Skin irritation or allergy from 
devices will be mitigated by 
immediate removal and 
discontinuation of the procedure. 
 
2.2.2 Benefit Assessment 
 
There are no direct benefits to the participant for participation in this study.  The 
findings may reveal information that will allow for the development of a new 
capillary blood collection device that may improve sample quality and patient 
experience during capillary blood collection, and thus may improve medical care 
for persons that undergo blood collection procedures.   
 
2.2.3 Overall Benefit: Risk Conclusion 
 
While there are no direct benefits to participants in this study, it is possible that the 
information gathered could benefit patients in the future.  There are no known or 
anticipated risks associated with the use of any study device other than those 
associated with general blood collection procedures.  Potential risks for participants 
are well known, have been minimized as reasonably feasible. The risk is low with 
a little chance of prolonged sequelae. 
 
3 
OBJECTIVES AND ENDPOINTS 
 
-- Protocol |

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 22 of 67 
 
3.1 
Acceptance Criteria 
For each comparison, clinical equivalence will be demonstrated for an analyte if the mean 
biases with 95% limits are within the Clinical Acceptance Limits (CAL). 
• If the mean bias is within the CAL but the 95% limit exceeds the CAL, it will be 
considered clinically non-equivalent, requiring further interpretation and assessment 
to determine whether the difference is clinically acceptable. This assessment will be 
made based on impact on patient diagnosis and treatment.   
• If the mean bias exceeds the CAL at any medically relevant points, it will be 
considered clinically non-equivalent and will be considered clinically unacceptable, 
unless a rationale can be provided. 
 
Objectives 
Endpoints 
Clinical Equivalence 
SERUM 
To demonstrate clinical equivalence of the 
 
 (Test Device SST) as compared to the 
relevant comparators for chemistry analytes 
listed in Table 3. 
Average difference between investigational device and 
respective comparator device. 
• 
Test Device SST vs. 
 
(Venous Comparator) 
• 
Test Device SST vs. 
 
(Capillary Comparator) 
EDTA 
 
To demonstrate clinical equivalence of the 
 
 (Test Device EDTA) as compared to 
the relevant comparators for whole blood 
parameters listed in Table 5. 
Average difference between investigational device and 
respective comparator device. 
• 
Test Device EDTA vs. 
 EDTA 
(Capillary Comparator) 
• 
Test Device EDTA vs. 
 
EDTA (Venous Comparator) 
Visual Observations and Supplemental Measurements: SERUM 
Evaluation of the frequency of selected visual 
observations in the 
 
 
 (Test Device 
SST) and all comparator tube types: 
• 
 
• 
  
Frequency of selected visual observations (Table 4). 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 23 of 67 
 
• 
Greiner Vacuette Serum 
To evaluate sample hemolysis as measured 
by Plasma Free Hemoglobin (PFH) on 
Siemens Atellica platform for 
 
 
 
 and all comparator tube types:  
• 
 
 
  
 
 
Mean and distribution of PFH values per tube type and 
frequency of PFH occurrence above 
 per tube 
type. 
To evaluate serum collection volume of the 
Test Device SST tube  
Serum collection volume as measured by the weight of 
serum in the 
 
 
 
To evaluate duration of sample collection for 
 
(Test Device SST tube) tube and 
capillary comparator
 
Mean time in seconds between puncture timestamp and 
additive/ blood mix start timestamp per tube type. 
Visual Observations and Supplemental Measurements: EDTA 
Evaluation of the frequency of visual 
observations in the 
 
 
 (Test Device 
EDTA tube) and all comparator tube types: 
 
 
 
 
 
 
Frequency of selected visual observations (Table 4). 
Evaluation of the frequency of occurrence of 
instrument flags (both asterisks and IP 
messages of interest) in the 
 
 (Test 
Device EDTA) and all comparator tube types: 
• 
 
 
 
 
 
 
 
 
Frequency of occurrence of instrument flags. 
Confirmation of relevant flags by manual review of 
smears. 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 24 of 67 
 
To evaluate peripheral blood smears for 
samples with platelet clump instrument IP 
messages. 
• 
Frequency of occurrence of platelet clump 
instrument flags, confirmed by peripheral smear 
review.  
• 
Frequency of instrument platelet clump flags with 
no platelet clumps identified on peripheral smear. 
To evaluate whole blood collection volume 
for the 
 
 
 (Test Device EDTA) 
Whole blood collection volume as measured by the 
weight of whole blood in the Test Device EDTA tube 
after collection.  
To evaluate duration of sample collection for 
the 
 
 EDTA and 
capillary comparator-
 
Mean time in seconds between puncture timestamp and 
additive/blood mix start timestamp per tube type. 
 Device Safety Assessment 
To assess the safety of the Test Device SST 
and EDTA systems.  
Device/procedure - related adverse events (AEs). 
For Informational Purposes Only:  
SERUM 
Evaluate clinical equivalence between 
comparator tubes for the chemistry analytes 
listed in Table 3. 
Average difference for tube comparisons. 
• 
Test Device SST tube vs. 
 
 (Venous Comparator) 
• 
 SST vs. 
 
Serum 
• 
 SST vs. 
 SST 
tube 
• 
 SST™ tube vs. 
 
 Serum 
EDTA 
Evaluate clinical equivalence between 
comparator tubes for all analytes listed in 
Table 5. 
 
Average difference between the following devices 
• 
Test Device EDTA tube vs. 
 
  
• 
 EDTA vs. 
 EDTA 
• 
 EDTA vs. 
 EDTA 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 25 of 67 
 
• 
 EDTA vs. 
 
EDTA 
 
4 
STUDY DESIGN 
 
4.1 
Overall Design 
 
This is a prospective, multi-center randomized collection study designed to evaluate the 
safety and effectiveness of the 
 Blood Collection 
System using the 
 (SST™ and EDTA) and 
to provide the necessary data to demonstrate substantial equivalence of these Test Device 
tubes to their respective comparators. 
This study will be conducted in two parts; Part A will evaluate the Test Device SST™ tubes 
and Part B will evaluate the Test Device EDTA tubes.  A minimum of 100 participants, and 
a maximum of 150 participants per part will be enrolled at a minimum of three various 
site settings representative of the intended use environment 
 
. Additional participants may 
be enrolled in order to obtain 100 complete data sets for all analytes. All participants will be 
compensated at the completion of study procedures.  
Natural Samples will be collected by representative future users of the 
 
 Blood Collection System who may not have prior blood collection 
experience. Persons who perform 
 
 
. Prior to participation in the study, all users will receive training on 
use of study products. 
 tubes will be collected 
. Persons who perform collection of the comparator 
 
 
Samples will be collected, clotted (serum samples only), centrifuged (serum samples only), 
and transported prior to analyte testing at 
. Note: Serum samples must 
be centrifuged within 2 hours of collection time (see Section 7).  
The study population will include apparently healthy participants and patient populations 
covering a range of disease states (See Section 5). The goal is to maximize coverage of the 
assay measurable range for each analyte, including above and below medical decision levels 
and at the extremes of the range, with natural samples, where possible. An overview of the 
reference range, critical values, and assay measurable range for each parameter is provided 
in Appendix A.  
 
To ensure measurements are obtained to cover the assay measurable range (AMR), 
approximately 10% contrived samples will be prepared for each analyte.  Preparation of 
these samples will be described under a separate Spiking Plan. A separate group of 
approximately 20 participants will be enrolled
 
 
  
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 26 of 67 
 
 
4.2 
Scientific Rationale for Study Design 
 
This study is designed to determine the clinical performance of the Test Device tubes 
against currently marketed capillary and venous blood collection devices in testing of both 
serum analytes and whole blood analytes. 
 
 collect 
 
 the comparator devices.  
 Test Device 
tubes, blood collection will be carried out by the targeted users of the Test Devices, 
 
 
 
 
The analytes selected to be tested in this study represent the intended use of the devices. 
 
The patient population was selected in order to cover the assay measurable range (AMR) 
using natural (uncontrived) samples to reflect real-world use.  Measurements of certain 
analytes at the extreme ends of the AMR may not be sustainable to life or it may just not 
be possible to recruit the participants to span the full range. Therefore, in order to cover 
this range, approximately 10% of the paired samples used in each analysis may be 
contrived. 
 
4.2.1 Participant Input into Design 
 
Not applicable. 
 
4.3 
End of Study Definition 
 
A participant is considered to have completed the study after he/she has completed blood 
collection and is discharged from the collection location, even if not all the study tubes are 
collected. 
 
The end of the study is defined as the date of the analysis of the samples collected from the 
last participant in the study.  
 
5 
STUDY POPULATION 
Natural Sample Group 
Participants will be recruited 
 
 in-person, via phone, or via 
electronic communications, such as social media, using IRB-approved recruitment materials. 
In order to cover the assay measurable range (AMR) additional in- and out- patient hospital 
populations with disease states such as the below listed conditions may be enrolled.  
• Part A: Patients with hepatic, renal, endocrine, cardiovascular disorders and/or cancer. 
• Part B: Patients with hematological disorders, cancers, diabetes and/or allergies. 
-- Protocol |

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 27 of 67 
 
Approximately equal number of female and male participants with a targeted enrollment of at 
least 30% of either gender 
 
. The patient disease state and gender will be documented on a CRF. 
 
Contrived Sample Group 
Participants enrolled for the preparation of contrived samples 
 
 
  
 
5.1 
Inclusion Criteria 
 
Natural Sample Group 
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria:  
1. Participants ≥18 years of age. 
2. Not currently pregnant (self-reported) 
3. Adequate access to four fingers 
 and inner 
elbows for blood collection procedures 
4. Willing and able to comply with all study procedures and evaluations 
5. Ability to read, write, and understand English language  
6. Provision of signed and dated informed consent form 
 
Contrived Sample Group 
Participants enrolled for the preparation of contrived samples must meet the criteria laid out 
within the 
. Participants who have been enrolled within 
 have 
already been screened according to the inclusion criteria for that program. 
 
5.2 
Exclusion Criteria 
 
Natural Sample Group 
Participants are excluded from the study if any of the following criteria apply: 
 
1. Evidence of skin issues such as infections, ulcerations, blisters, peripheral vascular 
disease, inflammation, extensive scarring or calluses, or healed burns at the 
 site.  
2. Subject to post-study exclusion period for this or other related studies: 
a. A study participant may enroll once in study part A and once in study part 
B of this clinical study. They may not enroll more than once in a single 
study part. 
b. If a study participant has previously enrolled in one study part and would 
like to enroll in the second study part, they must wait 
 from the time 
of the first study part collection procedures to enroll in the second study part 
collection procedures. 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 28 of 67 
 
3. Any condition which, in the opinion of the Investigator, would preclude 
participation in this study. 
 
Contrived Sample Group 
Participants enrolled for the preparation of contrived samples must meet the criteria 
 
 
 
 
5.3 
Lifestyle Considerations 
 
There are no required lifestyle considerations or restrictions. 
 
5.4 
Screen Failures 
 
Screen failures are defined as participants who do not meet all eligibility criteria.  
Individuals who do not meet the criteria for participation in this study (screen failure) may 
not be rescreened.  
 
6 
STUDY INTERVENTIONS 
 
6.1 
Investigational/Test Device 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
   
 
 
  
 
 
  
-- Protocol | 

Protocol Number:
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 29 of 67 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.2 
Comparator Devices/Standard of Care 
 
Part A 
• [T03-T04] 
 SST™ Tube 
 SST), 400-600 µl, 
, or equivalent. 
• [T05] 
 SST™ Blood Collection Tube (
 SST), 
 
, 
, or equivalent. 
• [T06] 
 Blood Collection Tube with Clot Activator and Gel 
Separator 
 or equivalent. 
 
Part B 
• [T08] 
 
EDTA), 
 or equivalent.  
• [T09] 
 EDTA), 
 or equivalent. 
• [T10] 
 
EDTA), 
 
 
6.3 
Ancillary Devices/Products 
 
• 
 
 
 
  
 
 
 
 
 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 30 of 67 
 
6.4 
Device Labeling 
 
Investigational devices (or the immediate packaging) shall be labeled in accordance with 
regulatory requirements, including the following statement: "For Investigational Use 
Only”. The performance characteristics of this product have not been established." 
 
The devices used during current venipuncture collection practices and capillary blood 
specimen collections are all commercially available and will be labeled as provided by the 
manufacturer.  
 
For contrived samples blood will be collected from participants 
 
 
  
 
6.5 
Measures to Minimize Bias 
 
6.5.1 Randomization 
 
All randomization schedules are to be provided by BD 
. 
Natural Sample Group 
Collection method (venous vs. capillary), tube collection order (within collection method), 
 location 
 will be randomized according 
to a draw schedule.  
 
 
 
Contrived Sample Group 
For the contrived samples, indirect draw order will be randomized according to a draw 
schedule. Tube testing order on instrument will be randomized according to a test schedule. 
 
6.5.2 Blinding/Masking 
 
Not applicable, this is an open-label study. 
 
7 
STUDY PROCEDURES AND ASSESSMENTS 
 
• Study procedures, assessments for natural samples and their timing are illustrated in 
the respective schemas provided in Section 1.2. Protocol waivers or exemptions are 
not allowed. 
• Adherence to the study design requirements is essential and required for study 
conduct. 
• Procedures conducted as part of the participant’s routine clinical management (e.g., 
blood count) and obtained before signing of the ICF may be utilized for screening or 
baseline purposes provided the procedures met the protocol-specified criteria. 
• The Instructions for Use (IFU) is a reference document for the investigational Test 
Device product; this study protocol will supersede the Test Device IFU. 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 31 of 67 
 
 
7.1 
Screening, Informed Consent, and Enrollment 
 
Potential study participants will be screened against the inclusion and exclusion criteria 
outlined in Section 5.  Participants will first be asked to provide written informed consent.  
Those who provide consent will be considered enrolled and will be assigned a unique 
participant number.  Those meeting eligibility criteria will receive information regarding the 
study, including but not limited to test procedures, information to be collected, number and 
type of blood collection procedures, potential risks and benefits, and other pertinent 
information.   
 
 
 
 
 
 
  
 
Part A 
Natural Sample Group: 
 
Contrived Sample Group: 
 
 
Part B  
Natural Sample Group: 
 
Contrived Sample Group: 
 
 
 
 
  
 
7.2 
 Blood Collection Procedure 
 
Natural Sample Group 
Study Part A:  
For each participant, 
 one venipuncture using a
 to 
collect blood into a 
 tube. The collection 
will be performed per the study site’s standard operating procedure for venipuncture. In 
addition, 
 collections using 
. A 
 
 
 the Test Device 
 system. The collection end time 
 for each conventional and Test Device capillary tube 
collected from a participant will be noted on the CRF. For venous collections, the collection 
end time will be the time of the last tube collected from a venipuncture draw. Duration of 
collection for all capillary collections (conventional and Test Device) will also be captured 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 32 of 67 
 
on CRFs as described in section 7.7 of this protocol, Supplemental Measurements, Visual 
Observations, and Analyte Testing. Study Samples will be mixed and processed per their 
respective IFUs.  
 
Study Part B: For each participant, 
 one venipuncture 
 
 to collect blood into a 
 
tube. The collection will be performed per the study site’s standard operating procedure for 
venipuncture. In addition, 
 one (1) conventional capillary 
collection 
 tube. 
 collection using the 
 
 Test Device EDTA system. The collection end 
time 
 for each conventional and Test Device 
 
tube collected from a participant will be noted on the CRF. For venous collections, the 
collection end time will be the time of the last tube collected from a venipuncture draw. 
Duration of collection for all capillary collections (conventional and Test Device) will also 
be captured on CRFs as described in the supplemental measurements section, section 7.7 of 
this protocol, Supplemental Measurements, Visual Observations, and Analyte Testing. 
 
Contrived Sample Group 
An overview of the spiking approach for the preparation of contrived samples is outlined in 
Appendix B. If multiple sets of contrived specimens are prepared from a single participant, 
each unique set of contrived samples will be assigned a unique pool number.  
 
7.3 Test Device Blood Collection Procedure  
 
Natural Sample Group 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 33 of 67 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 34 of 67 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
  
 
 
  
 
  
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 35 of 67 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
Step 9: Apply Gauze 
• Apply the sterile gauze or pad to the puncture site. Direct the patient to hold and 
apply pressure if they are able to assist. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The collection end time for each conventional and Test Device 
 tube collected from 
a participant will be noted on the CRF. For venous collections, the collection end time will 
be the time of the last tube collected from a venipuncture draw 
 
Contrived Sample Group 
The procedures for the collection of blood for the preparation of the contrived samples are 
outlined in the overview of the spiking approach in Appendix B. 
 
Once the contrived samples are indirectly transferred into the study tubes, they will be 
processed in the same manner as the natural samples. 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 36 of 67 
 
7.4 Repeat Collection 
 
In cases of insufficient sample volume or loss of sample during collection, repeat collection 
may be needed.  Repeat collection will vary based on blood collection method.  Participants 
should be asked for their permission before attempting a repeat collection. 
 
Natural Sample Group 
Part A: SERUM 
Capillary Collections – A total of four capillary collections will be performed 
 
 
 
 
 
 
 
 the event of an unsuccessful collection, the 
subject will be included in the study and the missing tubes will be noted. 
 
Venipuncture – 1 additional venipuncture will be allowed, for a total of 2 venipunctures 
for Part A of this study. 
 
Part B: EDTA 
Capillary Collections – A total of two capillary collections will be performed 
 
 
 
  
 
 
 
 
  
 
 
 
Venipuncture: 1 additional venipuncture will be allowed, for a total of 2 venipunctures for 
Part B of this study. 
 
Contrived Sample Group 
Repeat collections on participants enrolled for the preparation of contrived samples 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 37 of 67 
 
 
7.5 
Participant Compensation 
 
Participants will be compensated for their time and participation after the study procedures 
are complete. 
 
7.6 
Natural and Contrived Sample Storage and Processing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 38 of 67 
 
 
Part A: SERUM 
 
After tube inversions, all Serum tubes need to stand for their minimum clot times and then 
centrifuged as indicated in Table 1. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
. All tubes from the same participant 
 
 will be centrifuged within the same timeframe. Remove 
samples from centrifuge as soon as centrifugation is completed. 
 
. 
 
For Natural samples, all tubes from the same participant will be processed and tested at the 
same timeframe using the same lot of reagents. For contrived samples, all tubes from the 
same pool set will be processed and tested at the same timeframe using the same lot of 
reagents. 
 
 
 
 
 
 
 
 
 
 
Part B: EDTA 
 
Complete tube inversions as indicated in Table 1 for all EDTA tubes.  
 
All tubes from the same participant will be processed and tested at the same timeframe using 
the same lot of reagents. Place Test Device container into adapter for automated processing 
on the instrument. 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 39 of 67 
 
 
 
 
 
 
  
 
Table 1:  Tube Processing 
Tube 
Number 
Tube type 
Inversions* 
Minimum Clot 
Time 
Centrifugation † 
Time 
G-force (g) 
T01, T02 
 
 
 
 
 
 
T03, T04 
 
 
5 
45 min 
90 sec 
6500 
T05  
 
 
5 
30 min 
10 min 
1300 
T06 
 
 
5 
30 min 
10 min 
1800 
T07 
 
 
 
N/A 
N/A 
N/A 
T08 
 
 
 
8 
N/A 
N/A 
N/A 
T09 
 
 
8-10 
N/A 
N/A 
N/A 
T10 
 
 
8-10 
N/A 
N/A 
N/A 
†All serum tubes will be centrifuged within 2 hours of their respective collection end time. All tubes from the same 
participant (Natural Sample Group) or from the same contrived sample pool will be centrifuged within the same 
timeframe 
*Mix blood with additives in the tubes immediately after collection using the indicated number of tube inversions 
 
 
7.7 
Supplemental Measurements, Visual Observations, and Analyte Testing 
 
• Duration of collection (applicable to only Natural Samples): Defined as time in 
seconds between puncture timestamp and additive/blood mix start timestamp per 
-- Protocol |

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 40 of 67 
 
tube type. This parameter will only be collected for tubes T01-T04, Capillary 
collections. 
• Volume of Serum (applicable to only Natural Samples): 
 
 
 
• Plasma, Free Hemoglobin (applicable to Natural and Contrived Samples): As 
measured on Siemens Atellica. 
 
The following visual observations will be assessed during part A for Natural Samples. For 
Contrived Samples all visual observations in Table 2 also apply with the exception of the visual 
observation for collection failure.   
 
Table 2:Visual Observations for Part A  
Visual 
Observation 
Rating 
Description 
Ideal 
Rating 
Note 
Complete Fill 
1, 2, (3) 
 
 
 
 
 
 
 
 
 
 
 
 
2 
Performed 
after 
collection, 
right before 
mix start 
timestamp 
Collection Failure 
0, 1, 2, 3, 4 
 
 
 
 
 
 
 
 
 
 
0 
-- Protocol | 
Downloaded on 31 Oct 2023
System Version Number 1.0

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 41 of 67 
 
 
Fibrin mass 
(distinct from fibrin 
strands) 
0, 1, 2, 3 
 
 
 
 
 
 
 
 
0 
Performed as 
soon as 
possible after 
centrifugation 
and prior to 
testing  
Fibrin strands 
(distinct from fibrin 
masses) 
Y/N 
 
 
 
N 
Gel Barrier 
formation 
0, I, C 
  
 
 
C 
Red blood cells on 
barrier 
0, 1, 2, 3 
 
 
 
 
0 
Hemolysis 
0, 1, 2, 3 
 
 
 
 
0 
*Complete fill will be determined by visually comparing the venous tubes to an example tube set (reference tubes). 
 
 
 
7.7.1 Part A: SERUM (Natural and Contrived Samples) 
 
Serum samples from the Test Device 
 and comparator tubes will be tested (‘analysis 
time’) on the Siemens Atellica platform after centrifugation as noted in Table 3 and within 
4 hours from the collection end time. For the contrived samples the full panel of analytes 
may not be run on each contrived sample set. The specific analytes to be tested for each 
contrived sample set will be detailed in the Spiking Plan. Analysis time is defined as the 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 42 of 67 
 
time at which the sample is aspirated by the instrument.  All serum samples from the same 
subject will be tested within the same timeframe using the same lot of reagents. Test Device 
SST tubes should be
 to enable serum sampling from 
the primary tube. 
 tubes may be aliquoted into sample cups prior to 
analysis. 
 
Table 3: Analytes to be Measured in Part A Natural and Contrived Samples 
Analytes 
Abbreviation 
 
 
Immunoassays 
Thyroid-Stimulating 
Hormone 
TSH 
 
 
 
Vitamin D 
Vit D 
 
 
 
Enzyme 
Alkaline Phosphatase 
ALP 
 
 
Alanine Aminotransferase 
ALT 
 
 
Aspartate 
Aminotransferase 
AST 
 
 
Lipid 
High-Density Lipoprotein 
HDL 
 
 
Low-Density Lipoprotein 
LDL 
 
 
Total Cholesterol 
CHOL 
 
 
Triglycerides 
TRIG 
 
 
Metabolic 
Albumin 
ALB 
 
 
Total Bilirubin 
TBIL 
 
 
Blood Urea Nitrogen 
BUN 
 
 
Calcium 
Ca 
 
Carbon Dioxide 
CO2 
 
 
Chloride 
Cl 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 43 of 67 
 
Creatinine 
CRE 
 
 
Glucose 
GLU 
 
 
Potassium 
K 
 
 
Sodium 
Na 
 
 
Total Protein 
TP 
 
 
 
By default, TSH will be measured in capillary tubes T01 
 and T03 
 
 The remaining chemistry analytes will be tested from T02 (Test Device SST) 
and T04 
.  If necessary, leftover serum from either tube of the same tube 
type, from the same participant can be used for repeat analysis, only for the analytes listed above. 
 
7.7.2 Part B: EDTA 
Supplemental Measurements: 
• Duration of collection (applicable to only Natural Samples): 
 
 
. This parameter will only be collected for 
, T07 and 
T08. 
• Volume of Whole Blood (applicable to only Natural Samples): 
 
 
 
 
• Smear Reviews: (applicable to Natural and Contrived Samples) Peripheral smears 
will be reviewed in response to applicable instrument flags. Details on smear 
reviews provided below. 
 
The following visual observations will be assessed during part B for Natural Samples. For 
Contrived Samples only the visual observation of complete fill will be assessed. 
Table 4:  Visual Observations for Part B 
Visual 
Observation 
Rating 
Description 
Ideal 
Rating 
Note 
Complete Fill 
1, 2, (3) 
 
 
 
 
2 
 
 
Performed after 
collection, right 
before mix start 
timestamp 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 44 of 67 
 
 
 
 
 
 
 
 
 
Collection 
Failure 
0, 1, 2, 3, 4 
 
 
 
 
 
 
 
 
 
 
 
0 
*Complete fill will be determined by visually comparing the venous tubes to an example tube set (reference tubes). 
 reference tubes will be provided to illustrate an acceptable fill 
volume 
  
 
Testing to be done in Part B includes the following whole blood parameters and instrument 
platforms (Table 5). EDTA samples from the Test Device EDTA and comparator tubes will be 
tested (‘analysis time’) within 4 hours from collection end time. For the contrived samples the full 
panel of analytes may not be run on each pooled set. The specific analytes to be tested for each 
pooled set will be detailed in the Spiking Plan. Analysis time is defined as the time at which the 
sample is aspirated by the instrument (instrument print out time). All tubes from the same 
participant will be processed at the same timeframe using the same lot of reagents. Test Device 
EDTA tubes will be 
 to enable primary tube sampling. Testing for EDTA 
Tubes will be performed at room temperature. 
 
Table 5: Analytes to be measured in Part B Natural and Contrived Samples 
Analytes 
Abbreviation 
 
 
Instrument 
Basophils (%) 
BA 
 
Sysmex XN 1000 
Eosinophils (%) 
EO 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 45 of 67 
 
Erythrocyte Count 
 
RBC 
 
Hematocrit 
Hct 
 
Hemoglobin 
Hgb 
 
Leukocyte Count 
WBC 
 
Lymphocytes (%) 
LY 
 
Mean Corpuscular 
Hemoglobin 
MCH 
 
Mean Corpuscular 
Hemoglobin 
Concentration 
MCHC 
 
Mean Corpuscular 
Volume  
MCV 
 
Monocytes (%) 
MO 
 
Neutrophils (%) 
NE 
 
Platelet Count 
PLT 
 
Red Cell Distribution 
Width (RDW-SD / RDW-
CV) 
RDW-SD / 
RDW-CV 
 
Instrument flags 
N/A 
 
Hemoglobin A1c 
HbA1c 
 
Bio-Rad D-100  
* 
 
 
 
Relevant instrument flags will be confirmed with manual blood smears. Blood smears will be 
prepared on all tubes with instrument flags (asterisks and IP messages), as appropriate.  For platelet 
flags, 10 high power fields on the smear will be scanned for platelet clumps and rated according 
to the below criteria. 
 
None Seen 
 
Slight 
 
 
 
 
 
 
-- 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 46 of 67 
 
Moderate 
 
 
 
Marked 
 
 
 
7.8 
Natural and Contrived Sample Acceptance and Rejection Criteria for Analyte Testing 
Part A: Samples with the following visual scores will be rejected: 
- 
Complete Fill 
 
- 
Collection failure 
 
- 
Gel Barrier 
 
- 
Visual Hemolysis 
 
 
Part B: Samples with the following visual scores will be rejected: 
- 
Complete Fill 
 
- 
Collection failure 
 
 
7.9 
Repeat Testing Natural and Contrived Samples 
 
For study part A and B, repeat analyte testing is to occur on a per analyte basis following 
analyzer test run errors or flags during testing of the analyte, as deemed appropriate by the 
laboratory staff per their procedures. Repeat analyte testing should occur within the 
prescribed test window for each study part (within 4 hours of collection for Part A, and 
within 4 hours of collection for Part B).  
 
If upon the first run, a valid test result is not obtained due to any test run error or no numerical 
value is obtained, a repeat test should be run, volume permitting. Both the original and repeat 
test result will be provided and clearly marked.  
 
For Part B, if a 
 instrument flag is noted on the test report, a smear will be prepared 
and reviewed. Check the sample for the following and repeat the test on the 
 
 
 
1. Adequate sample volume 
2. Mix sample well, (observe for any “hang-up” in sample tube- smaller tubes need more 
time with the inversions to mix well) 
3. Check sample integrity – no clots within sample or on tube top 
 
The first valid result will be used for analysis. If both the first and repeat run is flagged by 
an asterisk, this data point should be documented with the asterisk in the study database and 
the first result with the asterisk will be used in the analysis. 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 47 of 67 
 
 
7.10 Residual Sample Usage (Natural Sample Group Only) 
 
After study objectives are met, 
 samples of 
sufficient quantity to collect data supporting the use of the Test Device for analysis of 
additional analytes.  
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
-- Protocol |

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 48 of 67 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 In the event of voluntary study 
participant withdrawal, bio-banked samples will be destroyed per the study participant 
request 
 
 
Contrived Sample Group 
This section is not applicable to contrived samples. Contrived samples will be disposed of 
according to standard laboratory procedures after the completion of the clinical study 
testing.  
 
7.11 Safety Evaluations 
 
Natural Sample Group 
Adverse events will be actively collected while the participant is at the site and collected via 
self-report through telephone calls over 7 days after blood collection. 
 
Contrived Sample Group 
Safety Evaluations are outlined in document 
 
 
8 
PARTICIPANT DISCONTINUATION/WITHDRAWAL  
   
8.1 
Discontinuation/Withdrawal 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 49 of 67 
 
Natural Sample Group 
• A participant may withdraw from the study at any time at his/her own request or may 
be withdrawn at any time at the discretion of the investigator or sponsor for safety, 
behavioral, compliance, or administrative reasons. This is expected to be uncommon. 
• At the time of discontinuing from the study, no further study assessments will be 
performed. Adverse events that occur and are self-reported by the participant to the PI 
and study staff will be documented for up to 7 days after discontinuation from the study. 
• If the participant withdraws consent for disclosure of future information, the sponsor 
may retain and continue to use any data collected before such a withdrawal of consent. 
• If a participant withdraws from the study, he/she may request destruction of any 
samples taken and not tested, and the investigator must document this in the site study 
records. 
 
Contrived Sample Group 
Safety Evaluations are outlined in document 
 
 
8.2 
Lost to Follow-Up 
 
Not applicable, study will be completed in one visit. 
 
9 
ADVERSE EVENTS AND DEVICE DEFICIENCIES 
 
9.1 
Definitions of Events 
 
9.1.1 Adverse Events (AEs) 
 
An adverse event is defined as any untoward medical occurrence, 
inappropriate patient management decision, unintended disease or injury, or 
untoward clinical signs in participants, users, or other persons, with any 
connection to study related activities, whether or not related to the IVD 
medical device under investigation (ISO 20916).  In this study, participant 
AEs are limited to those occurring immediately before, during, and 
immediately after specimen collection.  Also, based on the nature of the study, 
test results will not be used for patient management decisions. 
 
For the purpose of this study, Adverse events will be collected by the study 
team from enrollment through completion of the study (once discharged). If 
an adverse event occurs during this time the PI is required to follow-up with 
the participant.  The clinical course of the event will be followed according to 
accepted standards of medical practice until the event resolves, stabilizes, or 
in the opinion of the Investigator, is no longer considered clinically 
significant.  The Investigator must document the adverse event outcome on 
the AE CRF through a follow-up call to the participant. 
                 
-- Protocol | 
Downloaded on 31 Oct 2023
System Version Number 1.0

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 50 of 67 
 
The participant may self-report any additional AEs that occur through 7 days post 
discontinuation by calling the site. 
 
 
 
9.1.2 Serious Adverse Events (SAEs) 
 
A serious adverse event is defined by ISO 20916 and/or 21 CFR 803.3 as an adverse 
event that:  
a. led to death  
b. led to serious deterioration in health that resulted in life-threatening illness 
or injury, resulted in permanent impairment 
c. life threatening (refers to any event in which the subject was at risk of 
death at the time of the event; it does not refer to an event which 
hypothetically might have caused death if it were more severe)  
d. required intervention to prevent permanent impairment/damage 
e. required inpatient hospitalization/prolonged hospitalization, or resulted in 
medical/surgical intervention to prevent life-threatening illness/injury or 
permanent impairment; or  
f. led to fetal distress, fetal death, or a congenital abnormality or birth defect 
g. important medical event that may require intervention to prevent one of the 
preceding conditions 
 
9.1.3 Adverse Device Effect (ADE) / Serious Adverse Device Effect (SADE) 
 
An adverse device effect is defined as any adverse event that is considered to be 
related to the use of an investigational medical device. This definition includes any 
event resulting from insufficiencies or inadequacies in the instructions for use, 
deployment, implantation, or operation or any malfunction of the investigational 
device (study device) and includes any event that is a result of a user error. 
 
A serious adverse device effect (SADE) is defined as an ADE that has resulted in 
any of the consequences characteristic of an SAE. 
 
9.1.4 Unanticipated (Serious) Adverse Device Effect (UADE/USADE) 
 
An unanticipated (serious) adverse device effect (UADE/USADE) is any (serious) 
adverse device effect on health or safety or any life-threatening problem or death 
caused by, or associated with, a study device, which by its nature, incidence, 
severity, or outcome has not been identified in the current instructions for use 
and/or current version of the risk analysis report, or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or welfare of 
participants. 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 51 of 67 
 
UADEs/USADEs will be reported to FDA as required by 21 CFR Part 812. 
 
9.2 
Severity of Adverse Events 
 
Each AE shall be assessed for its severity, or the intensity of an event, experienced by the 
participant according to the criteria below. 
 
Severity Rating 
Description 
Mild 
Event, signs, or symptoms that do not interfere with the participant’s 
daily activity, are usually considered self-limiting, can be treated with 
non-prescription type medications, and do not require medical 
intervention 
Moderate 
Event may interfere or cause low level inconvenience with the 
participant’s daily activity. Requires medical intervention and/or 
treatment; however, unlikely to require hospitalization or be 
considered potentially life-threatening in nature 
Severe 
Event may cause significant discomfort to the participant and/or 
interferes with the participant’s daily activity. Requires medical 
intervention and/or treatment to preclude a permanent impairment; 
may be life threatening and/or require hospitalization 
 
9.3 
Relationship of Adverse Event to Device(s)/Procedure 
 
Each AE will be assessed for its relationship to the study device or procedure according to 
the following guidelines. 
 
A.  Assess each AE for its relationship to the device or procedure. 
 
• Device Related: This category should be restricted to AEs directly 
attributable to any study device used during blood collection. 
 
• Procedure:  A procedure includes any study-related activity performed 
during the participant’s study visit. 
 
B.  The following categories shall be used for assigning the certainty of the 
relatedness. 
 
Relatedness 
Description 
Not Related 
Event is independent of study intervention and/or evidence 
exists that the event is related to another etiology. There must 
be an alternative etiology documented by the clinician. 
Unlikely Related 
Event in which the temporal relationship to study intervention 
makes a causal relationship improbable (e.g., the event did not 
occur within a reasonable time of the study device use) and in 
which underlying disease provides plausible explanations (e.g., 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 52 of 67 
 
the 
participant’s 
clinical 
condition 
other 
concomitant 
treatments). 
Likely Related 
Event in which there is evidence to suggest a causal relationship 
and the influence of other factors is less likely. The event occurs 
within a reasonable time after use of the study device and is less 
likely to be attributed to concurrent disease. 
Related 
Event in which there is clear evidence to suggest a causal 
relationship and other possible contributing factors can be ruled 
out. The event occurs in a plausible time relationship to use of 
the study device and cannot be explained by concurrent disease. 
 
 
9.4 
Reporting of Events 
 
For all adverse events, all sections of the appropriate Case Report Form (CRF) must be 
completed. 
 
• All SAEs, SADEs, and/or UADEs/USADEs must be reported to the Sponsor within 
one (1) working day of the site/investigator becoming aware of the event.   
 
• De-identified copies of all requested relevant documentation should be submitted 
to the Sponsor within 72 hours of knowledge, as appropriate.  
 
It is the responsibility of the Investigator to report adverse events to individual Institutional 
Review Boards (IRBs)/Ethics Committees (ECs) and/or regulatory authorities according 
to the local regulations in each participating country. 
 
9.5 
Safety Committees 
 
A safety committee will not be used. 
 
9.6 
Device Deficiencies 
 
The Investigator will record a device deficiency if a device used in the study procedure 
failed to meet its performance specifications whether due to mechanical failure, 
malfunction, or defect.  Device deficiencies also include use errors and inadequate labeling.  
This applies to: devices used to treat the participant, or devices in which the package was 
opened, but the device was not used for treatment, or devices with which treatment was 
attempted, but the device did not remain through the entire study procedure/period. 
 
 
 
 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 53 of 67 
 
 
• 
 
 
 
 
 
 
 
 
 
 
  
 
If the device deficiency was associated with an AE, the reporting provisions for AEs, 
ADEs, SAEs, SADEs and UADEs/USADEs apply. 
 
Reported deficiencies will be investigated and reported under 21 CFR part 803 Medical 
Device Reporting by the Sponsor if necessary.  The site may be contacted to provide 
additional information to allow the Sponsor to conduct a thorough investigation. 
 
It is the responsibility of the Investigator to notify the IRB/EC of such device deficiencies 
in accordance with the IRB/EC and/or the Competent Authority’s local regulations. 
 
10 STATISTICAL METHODS 
 
The statistical analysis plan (SAP) will be finalized prior to database lock and will include a 
more technical and detailed description of the statistical analyses described in the following 
sections. This section includes a summary of the planned statistical analyses of the most 
important endpoints including primary and key secondary endpoints. 
 
10.1 Overview of Study Design 
This is a prospective, multi-center random sample collection study designed to evaluate the 
clinical equivalence of the blood collection device with Test Device 
 and EDTA tubes 
vs. respective comparators.    
 
 
10.2 Sample Size Considerations 
 
For clinical equivalence, 100 paired samples provide at least 90% power to ensure that mean 
biases and confidence intervals are within the clinically acceptable limits (CAL) at medical 
decision points, assuming no true bias between the tubes, residual SD, or CV ≤ CAL, and 
collected data extend past the medically relevant points. 
 
10.3 Analysis Population 
 
Safety analysis (summary of all device/procedure - related AEs) will be conducted on all 
enrolled participants. 
 
-- Protocol |

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 54 of 67 
 
All data collected will be reviewed for possible exclusion based on significant protocol 
deviations.  Analysis will be performed on the resulting Per-Protocol (PP) dataset. Missing 
values will not be imputed and will not be included in any analyses. 
 
Visual assessments: all collected tubes will be included in the summaries and analyses.  For 
duration of sample collection, only tubes with complete fill will be included in the 
summaries and analyses. 
 
Analytes:  Pre-specified specimen exclusion criteria will be applied. Analysis will be 
performed on all first reported valid result unless a reason is provided for specific 
exclusions. Reasons for such exclusions will be included in the statistical report. If repeat 
tests are performed, a list of participants and tubes showing the initial and repeat results 
will be provided, showing which result is used in the analyses. For each investigational 
device vs. respective comparator device comparison, only participants with valid results in 
both tubes will be included in the bias analysis.   
 
In addition, for study Part B, platelet analysis, a primary analysis of platelet results will be 
conducted excluding samples (from all tube types) with platelet flags confirmed with 
platelet clumps on smear review. Platelet flags and smear review data will be tabulated per 
tube type and sample type. An additional analysis will be done including all data, with and 
without platelet flags. 
 
 
 
 
10.4 General Considerations 
 
An alpha level of 5% will be used for all analyses. For equivalence testing with analytes 
having a CAL, this corresponded to obtaining 90% confidence intervals (associated with 
95% two 1-sided tests). 
 
For all analytes and continuous response metrics summary statistics including sample size, 
mean, standard deviation (excluding analytes), range of data obtained (minimum and 
maximum value) will be provided for each device. 
 
For visual observations and categorical observations, number of observations and percent 
in each category will be summarized for each device. 
 
 
 
 
 
 
 
  
 
 
 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 55 of 67 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.5 Analysis Methods 
 
10.5.1 Clinical Equivalence Endpoints 
For each analyte and each comparison, Deming regression (weighted Deming for analytes 
with percent CAL) or Passing-Bablok Regression will be used to estimate average 
differences between the investigational device and comparator device at medical decision 
levels (MDLs) for each analyte.  Average differences with 95% confidence limits will be 
compared to the CALs to determine clinical equivalence between the devices. 
 
10.5.2  Visual Observations and Supplemental Measurements Endpoints 
 
The distribution of visual observation ratings for each tube type will be tabulated and 
summarized. No analysis will be performed on the visual observations data from this 
protocol alone; visual observations for Natural Samples from multiple protocols will be 
combined for analysis, as specified in a separate Meta-Analysis plan. For the Test Device 
 a meta-analysis plan will assess for the Natural Samples the plasma free hemoglobin, 
serum volume, duration of sample collection, fibrin mass, complete barrier formation, and 
complete fill. For the Test Device EDTA, a meta-analysis plan will assess for the Natural 
Samples the whole blood volume, complete fill, duration of sample collection, and 
instrument flag frequencies.  
 
10.5.3  Safety Analysis Endpoints 
A summary of all Device/procedure - related adverse events (AEs) will be provided. 
 
10.6 Interim Analysis 
 
 
 
 
 
 
   
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 56 of 67 
 
 
 
 
   
 
 
 
  
 
 
 
 
 
11 DATA COLLECTION AND RECORD MAINTENANCE 
 
11.1 Case Report Forms 
 
The Investigator is responsible for ensuring the completeness and accuracy of all study 
documentation. 
 
All required clinical data will be collected/documented in sponsor-provided paper source 
and electronic Case Report Forms (CRFs). FDA 21 CFR 11 is followed as well as other 
applicable legislation on the handling of electronic data. Modification of the CRFs will 
only be made if deemed necessary by the Sponsor and/or the appropriate regulatory body. 
 
Site numbers and participant numbers will be used to track participant information 
throughout the study.  Participant personal information will be pseudonymized/de-
identified. 
 
11.2 Source Documentation 
 
Original or certified copies of all relevant clinical findings, observations, and other 
activities throughout the clinical investigation must be recorded and maintained in the 
study file of each enrolled participant.  Where there is no prior written or electronic record 
of data, such as for subjective data (e.g., pain scales, questionnaires), these data may be 
recorded directly on the CRF(s) and the CRF is then considered to be the source.  
 
11.3 Data Management 
 
Data management is the responsibility of the Sponsor.  Data from completed CRFs will be 
managed in a secured, controlled database.   A Data Management Plan (DMP) will be 
developed that outlines the procedures used for data review, database cleaning and 
issuing/resolving data queries. Procedures for validations and data storage will also be 
contained within the DMP. 
 
-- Protocol | 

Protocol Number:
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 57 of 67 
 
11.4 Record Retention 
 
The Investigator shall retain all study records for a minimum of two (2) years after the later 
of the following two dates: the date on which the study is terminated/completed or the date 
that the records are no longer required for purposes of supporting a pre-market approval 
application or a notice of completion of a product development protocol (21 CFR Part 
812.140). The data for some of these records may be available in computerized form but 
the final responsibility for maintaining study records remains with the Investigator. 
 
The Investigator may withdraw from the responsibility to maintain records for the period 
required by transferring custody of the records to any other person who will accept 
responsibility for retaining them. Notice of a transfer shall be given to the Sponsor and 
FDA, if applicable, not later than ten (10) working days after the transfer occurs. 
 
12 QUALITY CONTROL AND ASSURANCE 
 
12.1 Control of Study Products 
 
Investigational study products will be released only for use by Investigators who have 
obtained written IRB/EC approval (as required) for participation in this study, who have 
completed all required study documentation, and who have been qualified by the Sponsor.  
Investigators must maintain control over all study products, and ensure they are used in 
accordance with this protocol.  Failure to do so may result in the Sponsor suspending or 
terminating the study at the Investigator’s site.  
  
The Investigator will ensure that study products are only dispensed to participants (or used 
for specimens) properly enrolled in the study. The Investigator must maintain records of 
receipt, disposition, return and/or destruction of all study products. All investigational 
study products released to the site must be accounted for at the unit level prior to study 
close out, regardless of disposition.  The Sponsor-Monitor will regularly review all records 
regarding study product accountability.  
 
The Sponsor will maintain records that document the shipment, receipt, disposition, return 
and/or destruction of study products. 
 
12.2 Monitoring 
 
The Sponsor will designate trained and qualified personnel to monitor the progress of this 
clinical study in accordance with established standard operating procedures and the study-
specific Monitoring Plan.   
 
Prior to study start, a study initiation visit (SIV) will be conducted to review with the 
Investigator(s) and staff the provisions and proper conduct of this study. This visit will 
include a detailed review of this protocol, verification that all necessary documents are on 
file at the investigational site and confirmation of IRB/EC approvals.   
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 58 of 67 
 
 
During the study, routine monitoring visits (RMVs) will be conducted to assure the site 
continues to adhere to the protocol, the investigator agreement, and regulations regarding 
conduct of clinical studies.  The Sponsor-Monitor will confirm that the ICF to be used is 
the version approved by the IRB/EC, confirm the applicable national privacy laws have 
been followed, verify that all necessary documents are on file at the investigational site and 
confirm that there are provisions to continue and maintain all documents and records 
throughout the study as required by applicable regulations. These monitoring visits will 
assess continued protocol compliance, adequate participant enrollment, accurate data 
reporting, monitoring of participant safety through identification and/or review of any 
device-related AEs, UADEs, or SAEs, device accountability, continued maintenance, and 
calibration of study-specific equipment (if applicable), and continued IRB/EC acceptance 
of the study. 
 
At the completion of the study, the Sponsor-Monitor will conduct a final close-out visit or 
COV. The purpose of this visit may include but is not limited to collecting all outstanding 
study data documents, confirming that the Investigator’s files are accurate and complete, 
reviewing the record retention requirements with the Investigator, providing for the return 
of unused devices to the Sponsor, reviewing records which account for device shipments 
and ensuring that all applicable requirements for closure of the study are met.  
 
12.3 Audits and Inspections 
 
If the study is selected for audit by the Sponsor or if there is an inspection by the appropriate 
Health Authorities, the Investigator and his team will make themselves available during 
the visit.  The Investigator must agree to the inspection of all study related records and give 
the auditor/inspector direct access to source documents for verification of data on CRFs.  
The participant’s anonymity must be ensured, and data checked during the audit must 
remain confidential. 
 
As soon as the Investigator is aware of an upcoming inspection/audit by the Health 
Authorities, he/she will promptly inform the Sponsor.  As agreed with the Investigator, 
Sponsor personnel may be present at the site during the inspection. 
 
12.4 Protocol Deviations 
 
A protocol deviation is defined as an event where the Investigator or site personnel did 
not conduct the study according to the protocol. 
 
Except when necessary to protect the life or physical well-being of a participant, protocol 
deviations are not permitted.  The Sponsor and the investigational site’s IRB/EC must be 
notified immediately if an emergency situation arises in which the safety of a participant 
may require immediate intervention different than that defined in the protocol.  This must 
be followed by written confirmation that describes the emergency action and outcomes, 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 59 of 67 
 
within five (5) working days from the date of the emergency action in accordance with the 
governing IRB/EC’s requirement.   
 
It is the Investigator’s responsibility to ensure that there are no deviations from the 
Protocol.  Except in an emergency, when a protocol deviation is planned or anticipated, the 
Sponsor should be contacted for approval.  Any and all deviations must be recorded on the 
appropriate CRF regardless of whether medically justifiable or sponsor approved.  Upon 
evaluation by the Sponsor, actions may be required to prevent additional deviations, such 
as retraining of the site, implementation of additional site procedures, and more frequent 
monitoring.  If these steps fail, more serious measures, up to and including termination of 
enrollment at the site. 
 
12.4.1 Occurrence of Special Interest 
 
An occurrence of special interest (OSI) is defined as an event that is outside of the 
reasonable control of the study site or Principal Investigator.  The event prevents 
completion of specimen processing and/or testing or could impact the integrity of 
the evaluation of data.  Examples of OSI include but are not limited to specimen 
handling accidents, specimen shipping/transport mishaps, and instrument/ ancillary 
device malfunction (excluding study device).   
 
An occurrence of special interest must be recorded on the appropriate CRF.  Upon 
evaluation by the Sponsor, actions may be required to prevent additional 
occurrences, such as retraining of the site, implementation of additional site 
procedures, and/or more frequent monitoring.   
 
13 ADMINISTRATIVE REQUIREMENTS 
 
13.1 Investigator and Site Selection 
 
The Investigator must be of good standing as an Investigator and knowledgeable in relevant 
areas of clinical research to ensure adherence to the requirements of this 
protocol, including the protection of human participants.  Other site personnel must have 
appropriate research experience and infrastructure to ensure adherence to this protocol 
and enrollment of sufficient numbers of evaluable participants. The curriculum vitae of the 
Investigator(s), Sub-Investigator(s) and Study Coordinator(s) will be maintained in the 
Sponsor’s files as documentation of qualification by training and experience. 
 
The Principal Investigator will sign the Investigator Agreement pages of this protocol, 
agreeing to comply with all applicable regulations and the requirements of this study as 
per the clinical study agreement.  
 
Any site that is deactivated prior to initial enrollment, either by the Sponsor or by the 
individual site itself, may be replaced. 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 60 of 67 
 
13.2 Training 
 
In addition to each Investigator and appropriate site personnel being trained on this 
protocol and study procedures during the Site Initiation Visit, product training will be 
provided by the Sponsor or designee and is required for each Investigator. Additional study 
staff (e.g., Sub-Investigator(s)) will also require device training provided from the Sponsor 
or proctoring by the PI. All training will be documented and filed at the investigational site 
and with the Sponsor. 
 
13.3 Required Documents 
 
An Investigator may not screen or enroll participants until authorized to do so by the 
Sponsor. At a minimum, the following documentation should be received by the Sponsor 
prior to the commencement of external study activities: 
• Fully executed Non-disclosure Agreement (NDA) between PI/site and Sponsor; 
• CVs., signed and dated within 2 years of study start for the PI and Sub-
Investigator(s); 
• CVs. for Study Coordinator(s); 
• Signed CSA by PI/site (or designee); 
• Signed Investigator Agreement Page by PI and Sub-Investigator(s); 
• Signed Financial Disclosure Statement by PI and Sub-Investigator(s); 
• Completed and Signed Training Log by PI and Sub-Investigator(s); 
• Study Personnel Identification list; 
• Written approval from the IRB/EC of both the protocol and ICF, and any other 
• applicable protocol specific material; and 
• IRB/EC Membership List, Assurance of Compliance Form, or equivalent. 
 
13.4 Publication Policy 
 
The sponsor believes that results of applicable clinical studies should be published in peer-
reviewed literature in a timely, accurate, complete, and balanced manner, regardless of 
study outcomes, whenever possible.  As such, at the conclusion of this study, an article 
may be prepared for publication in a reputable scientific journal.  Formal presentation(s) 
or publication(s) of data collected from this study will be considered as a joint publication 
by the investigator(s) and the appropriate personnel of the Sponsor. Authorship will be 
based on generally accepted criteria of the ICMJE (International Committee of Medical 
Journal Editors) and determined by mutual agreement. 
 
The publication of the principal results from any single-center experience within the study 
is not allowed until the preparation and publication of the multicenter results. Exceptions 
to this rule require the prior approval of the Sponsor. The analysis of other pre-specified 
and non-pre-specified endpoints will be performed by the Sponsor or its designee. Such 
analyses, as well as other proposed investigations or manuscripts will require the approval 
of the Sponsor. 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 61 of 67 
 
13.5 Study Registration 
 
In compliance with Title VIII of Public Law 110-85, known as FDA Amendments Act of 
2007 (FDAAA), the Sponsor will register this study and disclose study results in a publicly 
accessible database (i.e., ClinicalTrials.gov).  This study will be registered no later than 21 
days after commencing enrollment.  Study results will be posted to the website within 12 
months after regulatory and health authority approval. 
 
13.6 Termination of Study 
 
The Sponsor reserves the right to suspend enrollment or terminate the study at any time for 
any reason.  The Sponsor may suspend enrollment or terminate the study at a specific 
investigational site for reasons including, but not limited to, inadequate data collection, low 
participant enrollment rate, achievement of the total enrollment, conditions imposed by the 
reviewing IRB/EC and/or non-compliance with this protocol or other clinical research 
requirements. Written notice will be submitted to the Investigator in advance of such 
termination.  
 
In the event of study suspension or termination, the Sponsor will send a report outlining 
the circumstances to the IRB/EC, and all Investigators and Regulatory Authorities as 
required by regulation.  
 
14 ETHICAL AND REGULATORY CONSIDERATIONS 
 
14.1 IRB/EC Approval 
 
Investigators or designees must submit the study protocol, Informed Consent Form (if 
applicable), and all other locally required documentation to an appropriate IRB/EC and 
obtain study-specific written approval (favorable opinion) before being allowed to 
participate in the study. Before commencement of the study, the Investigator or designee 
must provide the Sponsor with written documentation of such approval.  The IRB/EC must 
give written renewal of the original approval at least annually to continue the study. A copy 
of the written renewal must be provided to the Sponsor. 
 
The IRB/EC will be notified of any amendments to the protocol, as well as possible 
associated information and consent form changes, where applicable, and written approval 
(favorable opinion) will be obtained prior to implementation, as applicable. 
 
The Investigator or designee is responsible for fulfilling any conditions of approval imposed 
by the IRB/EC, such as regular safety reporting, study timing, etc. The Investigator or 
designee will provide the Sponsor with copies of such reports. 
 
14.2 Informed Consent and Confidentiality (Natural Samples) 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 62 of 67 
 
Prior to any study procedure, the Investigator (or designee) must explain to each participant 
in layman’s terms, the nature of the study, its purpose, expected duration, and the risks and 
benefits of study participation. Also, participant will be informed of uses and disclosures 
of their medical information for research purposes, and their rights to access information 
about them. All applicable national privacy laws (e.g., HIPAA requirements in the US) will 
be followed in this study. The participants must be informed of their right to withdraw from 
the study at any time and for any reason without sanction, penalty, or loss of benefits to 
which they are otherwise entitled, and that withdrawal from the study will not jeopardize 
their future medical care. Participants will be informed of their right to new information 
and/or findings relating to the clinical study, and the process by which this information is 
made available. After this explanation, given sufficient time to decide whether to 
participate, before any study procedure is conducted, and before entering the study, the 
participant must voluntarily provide consent in accordance with 21 CFR Parts 50 and 56 
and ISO 14155:2011(E). The participant will receive a copy of his/her signed ICF. 
 
14.2.1 Confidentiality 
 
Participant confidentiality must be strictly held in trust by the Investigator, study 
staff, and the Sponsor.  Participant confidentiality and anonymity will be 
maintained by removal of identifiers from any data, documentation, or clinical 
samples submitted to the Sponsor. 
 
Any data collected meeting the definition of protected/confidential health 
information or personal identifying information will be collected and maintained 
using the designated authorizations and following privacy procedures as specified 
in the applicable health authority regulations.   
 
The Sponsor-Monitor, authorized representatives of the sponsor, and/or applicable 
Health Authorities may inspect all documents and records required to be maintained 
by the Investigator.  The Investigator/Site will permit access to such records.  
 
14.3 Regulatory Status 
 
The Sponsor has determined and documented this to be an IDE Exempt study based on 
congruency with 21 CFR 812.3.  This determination is based on the following assessment 
of the investigational device: 
 
• Is not intended as an implant; 
• Is not purported or represented to be for a use in supporting or sustaining human 
life; 
• Is not intended for a use of substantial importance in diagnosing, curing, mitigating, 
or treating disease, or otherwise preventing impairment of human health; and, 
• Does not present a potential for serious risk to the health, safety, or welfare of a 
participant. 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 63 of 67 
 
Classification of non-significant risk is documented in the Study Risk Assessment Form. 
 
14.4 Statement of Compliance 
 
This clinical investigation will be conducted in compliance with the protocol and following 
regulatory requirements: 
• 21 CFR 50, 54, 56 and 812; 
• 21 CFR 812.28(a)(1) (Good Clinical Practice); 
• Ethical principles of the Declaration of Helsinki, in its current revision; and 
• Applicable sections of the national laws and regulations. 
 
The clinical investigation will not commence at a clinical site until approval (favorable 
opinion) from the respective IRB/EC has been received. All additional requirements 
imposed by the IRB/EC(s) will be followed. Involvement of the national competent 
authorities (e.g., by notification, seeking authorization) will be accomplished as required 
by national laws and regulations. 
 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 64 of 67 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 65 of 67 
 
16 APPENDICES 
 
Appendix A: Reference Ranges, Critical Values, and Assay Measurable Ranges per Parameter 
Appendix B: Overview of Spiking Approach 
 
 
 
 
 
 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 66 of 67 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
-- Protocol | 

Protocol Number: 
 
 
CONFIDENTIAL 
Version: 4.0 
Date: 07 September 2022 
 
Page 67 of 67 
 
 
Appendix B: Overview of Spiking Approach  
 
Contrived Samples 
Overview:  Full details of the contriving approach and preparation steps to create abnormal low 
and abnormal high samples will be defined under a separate Spiking Plan. However, contrived 
samples will be created using the general approach below, using 
 
 and then prepared by addition of spiking/dilution material. Once contrived 
samples are prepared, they will be transferred into the Test Device and comparator tubes for 
processing. Multiple sets of contrived samples can be prepared from the blood collected from one 
participant. Collection metrics such as duration of collection, whole blood volume, and serum 
volumes will not be collected for contrived samples. All visual observations will be collected 
except for “collection failure” as these samples are indirectly collected. Following visual 
observations, all samples are expected to be processed and tested as per 
 
handling, processing, and testing.  
 
-- Protocol | 

--