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Instructions for Use380363-A

SSP available in EUDAMEDWARNINGS AND PRECAUTIONS

OC-FIT Calibrator
for OC-SENSOR MICRO, DIANA
for OC-SENSOR io, PLEDIA
for OC-SENSOR Ceres

REF V-PH51
REF V-PH52
REF V-PH02

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5.

INTENDED USE

OC-FIT Calibrator is intended for use as a calibrator used together with OCSENSOR FIT reagents on the dedicated automated immunochemical
analysers [OC-SENSOR series] to measure faecal haemoglobin.
OC-SENSOR FIT reagents are in vitro diagnostic reagents intended for thequantitative measurement of human haemoglobin in faeces. OC-SENSOR FIT
reagents aid in the diagnosis of colorectal cancer, neoplasia, dysplasia, polyps,and other disorders associated with gastrointestinal bleeding in conjunction
with other clinical findings. The test can be utilized in colorectal cancer
screening for asymptomatic population as well as in diagnostic aid andmonitoring for symptomatic patients. The test is noninvasive, usingstool/faeces as test sample. The reagents are used on the dedicatedautomated analysers by qualified personnel in clinical laboratories andhospitals.

MATERIALS PROVIDED
Productcode

Product nameContents

Storage

Compatible
analyserMICRO,DIANA
io,
PLEDIA

V-PH51

OC-FIT Calibrator

1 x 3 mL

2-8 °C

V-PH52OC-FIT Calibrator

1 x 3 mL

2-8 °C

V-PH02OC-FIT Calibrator

6 x 1 mL

2-8 °C

Ceres

Contents

Storage

Compatible
analyser

Productcode

Product name

V-PZ01

OC-SENSOR FIT Latex Reagent

5 x 15 mL

2-10 °C

V-PZ03OC-SENSOR FIT Buffer

1 x 500 mL

2-10 °C

DIANA,PLEDIA

V-PH18

OC-SENSOR FIT Latex Reagent

2 x 7 mL

2-10 °C

io

V-PH33

OC-SENSOR FIT Latex Reagent

2 x 7 mL

2-10 °C

MICRO

V-PH46

OC-SENSOR FIT Buffer

1 x 200 mL

2-10 °CMICRO, io

V-PH01

OC-SENSOR FIT
Latex Reagent
Buffer2 x 6 mL2 x 20 mL

2-10 °C

Ceres

V-PH53OC-FIT Control LV1

2 x 5 mL

2-8 °C

V-PH54OC-FIT Control LV22 x 5 mL

2-8 °C

V-PH59OC-FIT Control LV3

2 x 5 mL

2-8 °CV-PZ25

OC-Auto Sampling Bottle 3

100 bottles

1-30 °C

V-PZ26

OC-Auto Sampling Bottle 3
without barcode

100 bottles

1-30 °C

OC-SENSOR Sample Diluent

V-PH083 x 45 mL
2 x 20 mL

6.
7.

For in vitro diagnostic use only.
Do not freeze this product.
Do not use expired products.
Air bubbles on the surface of the product after being added into sample
cups can cause an erroneous measurement. The bubbles should beremoved.
OC-FIT Calibrator uses material derived from human blood. Only blood
testing negative for HBs antigens, HIV (HIV-1 and HIV-2) antibodies andHCV antibodies is used, but the presence of pathogens and infection risk
cannot be completely ruled out. Therefore, the product should be handled
carefully in the same manner as patient samples to ensure safety.
Use specific calibrator dedicated to a type of analysers and follow
instructions in the user manual.
Avoid contamination and evaporation by sealing the bottle properly with a
cap and put it back in the refrigerator after use. It is advised to minimize
the time left in room temperature and keep the calibrator refrigerated when
not in use. In-use stability can be altered if the instruction is not followed.

PROCEDURE

Create calibration curve in the manner described in the user manual of theautomatic analysers.

[OC-SENSOR PLEDIA, OC-SENSOR DIANA, OC-SENSOR io]

Add 600 μL (12 drops or more) of OC-FIT Calibrator into a sample cup. Add 2mL (or more) of OC-FIT Calibrator Diluent into another sample cup. Set thesesample cups on a rack according to the user manual and create calibration
curve.

[OC-SENSOR MICRO]

Add 400 μL (8 drops or more) of OC-FIT Calibrator into a sample cup. Add 2mL (or more) of OC-FIT Calibrator Diluent into another sample cup. Set thesesample cups on a rack according to the user manual and create calibration
curve.

[OC-SENSOR Ceres]

MATERIALS REQUIRED BUT NOT PROVIDED

V-PH19English

2-8 °CAllAllDIANA,PLEDIA,MICRO, ioCeres

REQUIRED MATERIALS NOT PROVIDED BY THE MANUFACTURER
Prepare these materials before measurement• Wash solution: Sodium hypochlorite 0.15% (0.10%–0.30% is acceptable)• Purified water for wash: Distilled or de-ionized water(1.0-10.0 MΩcm is acceptable)• Sample cups
• Printer paper: Thermal printer paper which fits the analyser

Add 150 μL (3 drops or more) of 6 levels of OC-FIT Calibrator individually into
6 sample cups. Set these sample cups on a rack according to the user manualand create calibration curve.
Note: Volume of 1 drop from the vial of OC-FIT Calibrator is approximately 50 μL.

New calibration curve should be created;• When the lot (batch) of latex reagent is changed.
• When the measurement value of OC-FIT Control (LV1/LV2/LV3) is not within
the control range.
• When opened latex reagent is used over 2 weeks.
• After maintenance support procedures.

In-Use Stability

OC-FIT Calibrator is stable for 2.5 months (10 weeks) after opening. The
stability for this period is kept if it is capped properly and put back in therefrigerator when not in use. In-use stability can be altered in case ofcontamination, evaporation and/or storage at improper temperatures.

NOTICEIn case of occurrence of any serious incident that has occurred in relation tothe device shall be reported to the authorised representative, themanufacturer, and the competent authority of the Member State in which theuser and/or the patient is established.

EXPLANATION OF SYMBOLSREAGENTS

OC-FIT Calibrator is liquid and ready to use requiring no preparation.
For OC-SENSOR MICRO, DIANA
OC-FIT Calibrator Hb 2000 ng/mL 1 x 3 mL
OC-FIT Calibrator Diluent
1 x 45 mL
For OC-SENSOR io, PLEDIA
OC-FIT Calibrator Hb 1000 ng/mL 1 x 3 mL
OC-FIT Calibrator Diluent
1 x 45 mL
For OC-SENSOR Ceres
OC-FIT Calibrator Hb 6 levels
6 x 1 mL
CAL1. 0 ng/mL
CAL2. 62.5 ng/mL CAL3. 125 ng/mL
CAL4. 250 ng/mL CAL5. 500 ng/mL CAL6. 1000 ng/mL

STORAGE

OC-FIT Calibrator is stable until the date printed on the label when stored at 28 °C.

Date of issuance: 2022-05-26