EXHIBIT 4

Case 2:23-cv-00585-JRG-RSP Document 21-4 Filed 05/08/24 Page 1 of 13 PageID #: 830
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

__________________________________________________________________________________________________________________________

Food and Drug Administration

10903 New Hampshire Avenue

Document Control Center – WO66-G609

Silver Spring, MD 20993-0002

ROCHE DIABETES CARE, INC.

KHONE SAYSANA

REGULATORY AFFAIRS PROGRAM MANAGER

9115 HAGUE ROAD

INDIANAPOLIS IN 46250-0457

Re: K160944

Trade/Device Name: ACCU-CHEK Guide Blood Glucose Monitoring System, 

ACCU-CHEK Guide Control Solutions

Regulation Number: 21 CFR 862.1345

Regulation Name: Glucose test system

Regulatory Class: II

Product Code: NBW, LFR, JJX

Dated: July 15, 2016

Received: July 18, 2016

Dear Mr. Saysana:

We have reviewed your Section 510(k) premarket notification of intent to market the device 

referenced above and have determined the device is substantially equivalent (for the indications 

for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 

commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to 

devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, 

and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 

You may, therefore, market the device, subject to the general controls provisions of the Act. The 

general controls provisions of the Act include requirements for annual registration, listing of 

devices, good manufacturing practice, labeling, and prohibitions against misbranding and 

adulteration. Please note: CDRH does not evaluate information related to contract liability 

warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 

it may be subject to additional controls. Existing major regulations affecting your device can be 

found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may 

publish further announcements concerning your device in the Federal Register.

Please be advised that FDA’s issuance of a substantial equivalence determination does not mean 

that FDA has made a determination that your device complies with other requirements of the Act 

or any Federal statutes and regulations administered by other Federal agencies. You must 

comply with all the Act’s requirements, including, but not limited to: registration and listing (21 

CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of 

medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements 

as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the 

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

1050.

August 31, 2016

Case 2:23-cv-00585-JRG-RSP Document 21-4 Filed 05/08/24 Page 2 of 13 PageID #: 831
Page 2—Mr. Saysana

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 

809), please contact the Division of Industry and Consumer Education at its toll-free number 

(800) 638 2041 or (301) 796-7100 or at its Internet address 

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note 

the regulation entitled, “Misbranding by reference to premarket notification” (21 CFR Part 

807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 

CFR Part 803), please go to 

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office 

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the 

Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)

796-7100 or at its Internet address 

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias, Ph.D.

Director

Division of Chemistry and Toxicology Devices

Office of In Vitro Diagnostics

and Radiological Health

Center for Devices and Radiological Health

Enclosure

For:

Katherine Serrano -S

Case 2:23-cv-00585-JRG-RSP Document 21-4 Filed 05/08/24 Page 3 of 13 PageID #: 832
	



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Case 2:23-cv-00585-JRG-RSP Document 21-4 Filed 05/08/24 Page 4 of 13 PageID #: 833
1 

510(k) Summary 

510(k) SUMMARY 

k160944 

Introduction 

According to the requirements of 21 CFR 807.92, the following information provides 

sufficient detail to understand the basis for a determination of substantial equivalence. 

1. Submitter Name, Address, Contact 

Roche Diabetes Care, Inc. 

9115 Hague Rd. 

Indianapolis, IN 46250 

(317) 521-7593 

Contact Person: Khone Saysana 

Date Prepared: August 30, 2016 

2. Device Name 

Proprietary names: Accu-Chek Guide Blood Glucose Monitoring System 

 Accu-Chek Guide control solutions 

 

Classification name: 

Glucose dehydrogenase, glucose test system (21 C.F.R. § 62.1345); Class II 

Single (Specified) Analyte Controls (Assayed and Unassayed) (21 CFR § 862.1660); 

Class I 

NBW, Blood Glucose Test System, Over-the-Counter

LFR, Glucose Dehydrogenase 

JJX, Single (Specified) Analyte Controls (Assayed and Unassayed) 

Case 2:23-cv-00585-JRG-RSP Document 21-4 Filed 05/08/24 Page 5 of 13 PageID #: 834
2 

510(k) Summary 

3. Predicate Device 

Accu-Chek Aviva Connect Blood Glucose Monitoring System (k141867), concurrence 

received on March 3, 2015. 

The Accu-Chek Aviva Controls (k043474), concurrence received on April 27, 2005. 

The Accu-Chek Aviva Connect Blood Glucose Monitoring System is intended for the 

quantitative measurement of glucose (sugar) in fresh capillary whole blood samples 

drawn from the fingertips. The Accu-Chek Aviva Connect Blood Glucose Monitoring 

System is intended to be used by a single person and should not be shared. 

4. Device Description 

The Accu-Chek Guide System consists of the following: 

• Accu-Chek Guide meter 

• Accu-Chek Guide test strips 

• Accu-Chek Guide control solutions (previously cleared in k043474) 

The Accu-Chek Guide Blood Glucose Monitoring System makes use of the Accu-Chek 

Guide test strips, the Accu-Chek Guide meter, and the Accu-Chek Guide control 

solutions. This system is a single-patient use blood glucose monitoring system intended 

to be used to quantitatively measure glucose in fresh capillary whole blood from the 

fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose 

control. It should be noted that the Accu-Chek Guide control solutions are identical to 

the Accu-Chek Aviva control solutions that were cleared previously in k043474. The 

name has simply been updated to reflect their use with the Accu-Chek Guide system. 

The components of the Accu-Chek Guide Blood Glucose Monitoring System are shown 

below: 

Case 2:23-cv-00585-JRG-RSP Document 21-4 Filed 05/08/24 Page 6 of 13 PageID #: 835
3 

510(k) Summary 

Case 2:23-cv-00585-JRG-RSP Document 21-4 Filed 05/08/24 Page 7 of 13 PageID #: 836
4 

510(k) Summary 

bG Measurement Technology Description 

The enzyme on the test strip, an FAD-dependent glucose dehydrogenase (GDH) 

expressed in A. Oryzae, converts the glucose in the blood to gluconolactone. This 

reaction creates a harmless DC electrical current that the meter interprets for the blood 

glucose result. The sample and the environmental conditions are evaluated using AC and 

DC signals. 

5. Intended Use 

The Accu-Chek Guide Blood Glucose Monitoring System is comprised of the Accu-Chek 

Guide meter and the Accu-Chek Guide test strips. 

The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively 

measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm 

as an aid in monitoring the effectiveness of glucose control. 

The Accu-Chek Guide Blood Glucose Monitoring System is intended for in vitro 

diagnostic single-patient use by people with diabetes. 

The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a 

single person and should not be shared. 

Case 2:23-cv-00585-JRG-RSP Document 21-4 Filed 05/08/24 Page 8 of 13 PageID #: 837
5 

510(k) Summary 

This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal 

use. 

Alternative site testing should be done only during steady-state times (when glucose is 

not changing rapidly). 

Accu-Chek Guide Control Solutions are for use with the Accu-Chek Guide Blood 

Glucose Monitoring System to check that the meters and test strips are working together 

properly and that the test is performing correctly.

6. Substantial Equivalence 

The Accu-Chek Guide system substantially equivalent to the Accu-Chek Aviva Connect 

system. Below is a table that provides a comparison between the Accu-Chek Guide 

system and its predicate device. 

Similarities and Differences Table 

 Accu-Chek Guide 

(k160944) 

Accu-Chek Aviva Connect 

(k141867) 

Indications for 

Use 

Quantitative measurement of 

glucose (sugar) in fresh capillary 

whole blood samples. 

Quantitative measurement of 

glucose (sugar) in fresh capillary 

whole blood samples. 

Alternate Site 

Testing 

Palm and Upper arm None 

Enzyme FAD-GDH Mut. Q-GDH 

Test Principle Amperometric Detection Amperometric Detection 

Primary 

Container (Vial) 

Black, flip top oval vial, holds up 

to 50 strips 

Closed vial height: 51 mm 

Width at widest point: 18.3 mm 

Width at narrowest point: 

15.3 mm 

White, flip top vial, holds up to 

50 strips 

Closed vial height: 52.8 mm 

Outer diameter: 30.15 mm 

Inner diameter: 28.15 mm 

Sample Volume 600 nanoliters 600 nanoliters 

Measurement 

Range 

20 – 600 mg/dL 20 – 600 mg/dL 

Case 2:23-cv-00585-JRG-RSP Document 21-4 Filed 05/08/24 Page 9 of 13 PageID #: 838
6 

510(k) Summary 

 Accu-Chek Guide 

(k160944) 

Accu-Chek Aviva Connect 

(k141867) 

Hematocrit 

Range 

10 – 65% 10 – 65% 

Operating 

Temperature 

Range 

6 – 45 °C 14 – 38 °C 

Operating 

Relative 

Humidity Range 

10 – 90% 10 – 80% 

Maximum 

Altitude 

10,150 feet 10,000 feet 

Underdose 

Detection 

Yes Yes 

Auto Control 

Solution 

Identification 

Yes Yes 

Control Solutions Aqueous, 2 Levels, cleared in 

k043474 

Aqueous, 2 Levels, cleared in 

k043474 

Strip Light Yes No 

Strip Ejector Yes No 

Connectivity USB for PC connectivity and 

BLE (Bluetooth Low Energy) for 

wireless connectivity 

USB for PC connectivity and 

BLE (Bluetooth Low Energy) for 

wireless connectivity 

Coding No No 

Case 2:23-cv-00585-JRG-RSP Document 21-4 Filed 05/08/24 Page 10 of 13 PageID #: 839
7 

510(k) Summary 

ACCU-CHEK Guide Controls Comparison 

 Accu-Chek Guide 

Controls 

(k160944) 

Accu-Chek Aviva 

Controls 

(k043474) 

Intended Use For use with the Accu-Chek 

Guide Monitoring System 

For use with the Accu-Chek 

Aviva Plus Monitoring System

Control Type Aqueous Aqueous 

Ingredients/Compostion Control solutions are identical 

Control Level 1 

Target 45 mg/dL 45 mg/dL 

Control Level 2 

Target 297 mg/dL 307 mg/dL 

Unopened Shelf-life 

storage 24 months 24 months 

7. Data demonstrating substantial equivalence 

Performance testing on the Accu-Chek Guide system demonstrated that the device meets 

the performance requirements for its intended use. The data demonstrate that the system 

is substantially equivalent to the predicate device. 

Below is the user performance data for the system: 

Results for glucose concentrations less than 75 mg/dL 

Within +5 mg/dL Within +10 mg/dL Within + 15 mg/dL 

8/12 (66.7%) 12/12 (100%) 12/12 (100%) 

Results for glucose concentrations greater than or equal to 75 mg/dL 

Within +5 % Within +10 % Within + 15 % Within + 20 % 

63/108 (58.3%) 103/108 (95.4%) 107/108 (99.1%) 108/108 (100%) 

Case 2:23-cv-00585-JRG-RSP Document 21-4 Filed 05/08/24 Page 11 of 13 PageID #: 840
8 

510(k) Summary 

Below is the user performance Palm AST data for the system: 

Results for glucose concentrations less than 75 mg/dL 

Alternate Site Within +5 mg/dL Within +10 mg/dL Within + 15 

mg/dL 

Palm 8/9 (88.9%) 9/9 (100%) 9/9 (100%) 

Results for glucose concentrations greater than or equal to 75 mg/dL 

Alternate 

Site 

Within +5 % Within +10 % Within + 15 

% 

Within + 20 

% 

Palm 175/363 

(48.2%) 

308/363 

(84.8%) 

356/363 

(98.1%) 

362/363 

(99.7%) 

Below is the user performance Upper Arm AST data for the system: 

Results for glucose concentrations less than 75 mg/dL 

Alternate Site Within +5 mg/dL Within +10 mg/dL Within + 15 

mg/dL 

Upper Arm 7/10 (70%) 10/10 (100%) 10/10 (100%) 

Results for glucose concentrations greater than or equal to 75 mg/dL 

Alternate 

Site 

Within +5 % Within +10 % Within + 15 

% 

Within + 20 

% 

Upper Arm 156/355 

(43.9%) 

281/355 

(79.2%) 

337/355 

(94.9%) 

351/355 

(98.9%) 

Below is the repeatability (within lot) precision for the system: 

Blood 1 2 3 4 5 

N 300 300 300 300 300

Mean [mg/dL] 40.5 81.7 132.1 206.7 330.2

SD [mg/dL] 1.4 2.0 2.8 5.4 8.6

CV [%] 3.5 2.4 2.1 2.6 2.6

Case 2:23-cv-00585-JRG-RSP Document 21-4 Filed 05/08/24 Page 12 of 13 PageID #: 841
9 

510(k) Summary 

Below is the reproducibility (intermediate or day-to-day) precision for the system: 

Control solutions Low Mid High 

N 300 300 300

Mean [mg/dL] 44.9 116.6 297.4

SD [mg/dL] 1.4 2.8 6.8

CV [%] 3.1 2.4 2.3

Case 2:23-cv-00585-JRG-RSP Document 21-4 Filed 05/08/24 Page 13 of 13 PageID #: 842