Instructions for Use

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sitio web / IFU sur notre site web / IFU auf unserer Website
https://www.eiken.co.jp/en/ifu

380318-C

EnglishOC-FCa Control LV1
OC-FCa Control LV2OC-FCa Control LV3

V-PH13
V-PH14
V-PH15INTENDED USE
OC-FCa Controls LV1/LV2/LV3 are intended for use as an internal
quality control in immunochemical faecal calprotectin tests. They areespecially compatible with OC-FCa Reagent on the automatedimmunochemical analysers [OC-SENSOR series] to measure faecalcalprotectin.
OC-FCa Reagent is in vitro diagnostic assay reagent intended for thequantitative measurement of calprotectin, inflammatory protein, infaeces. The OC-FCa Reagent aids in diagnostic and monitoring of
inflammatory bowel diseases (IBD; e.g. ulcerative colitis, andCrohn’s disease) in conjunction with other clinical findings. The test
can be utilized in diagnostic aid and in monitoring for symptomaticpatients. The test is noninvasive, using stool/faeces as test sample.
The reagent is used on the dedicated automated analysers by
qualified personnel in clinical laboratories and hospitals.
MATERIALS PROVIDED
Product
Product namecode
V-PH13 OC-FCa Control LV1
V-PH14 OC-FCa Control LV2
V-PH15 OC-FCa Control LV3Contents

Storage2 × 5 mL
2 × 5 mL
2 × 5 mL

2-8 °C
2-8 °C
2-8 °C

MATERIALS REQUIRED BUT NOT PROVIDED
Product
Product nameContentscode
2 × 8 mL
OC-FCa Reagent
V-PH11(OC-SENSOR PLEDIA)
2 × 15 mL
2 × 8 mL
OC-FCa Reagent
V-PH09(OC-SENSOR Ceres)2 × 15 mL
V-PH12 OC-FCa Calibrator
6 × 1 mL
V-PH19 OC-SENSOR Sample
3 × 45 mL
V-PH08 Diluent
2 × 20 mL

Storage
2-10 °C
2-10 °C
2-8 °C
2-8 °C
2-8 °C

V-PZ25

OC-Auto Sampling Bottle 3

100 bottles

1-30 °C

V-PZ26

OC-Auto Sampling Bottle 3
without barcode

100 bottles

1-30 °CREQUIRED MATERIALS NOT PROVIDED BY THE MANUFACTURER
Prepare these materials before measurement• Wash solution: Sodium hypochlorite 0.15% (0.10%–0.30% isacceptable)• Purified water for wash: Distilled or de-ionized water (1.0-10.0MΩcm is acceptable)• Sample cups
• Printer paper: Thermal printer paper which fits the analyser
REAGENTS
OC-FCa Control is liquid and ready to use requiring no preparation.
For OC-SENSOR PLEDIA, Ceres
OC-FCa Control LV1 (Middle)
2 × 5 mL
OC-FCa Control LV2 (High)2 × 5 mL
OC-FCa Control LV3 (Low)
2 × 5 mLWARNINGS AND PRECAUTIONS
1. For in vitro diagnostic use only.
2. Do not freeze this product.
3. Do not use expired products.
4. Start analyses immediately after setting the controls on a rackto avoid evaporation.
5. Air bubbles on the surface of the product after being added into
sample cups can cause an erroneous measurement. Thebubbles should be removed.
6. No human-derived materials are contained in this product;
however, the risk of infection and the possible existence of otherpathogens cannot be ruled out completely. The product should
be handled carefully in the same manner as patient samples toensure safely.
7. If reagents get into eye or mouth, rinse it out with large volumeof running water, and perform other first aid required. If
necessary, seek medical attention.
8. 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 andkeep the control refrigerated when not in use. In-use stability
can be altered if the instruction is not followed.
9. Disposal of used reagents and containers should be treated as
medical waste in accordance with applicable regulations.
10. The calprotectin concentration is printed on the label of eachbottle.
PROCEDURE
Minimum requirement is to analyse the OC-FCa Control LV1 and LV2
before sample analysis on a daily basis. Analyse OC-FCa Control
LV3 as required. Follow the detailed measurement procedure in theuser manual of the automatic analysers.
Add an appropriate amount of OC-FCa Control into a sample cup
and then operate the automatic analyser according to its instructions.
For a single measurement, it uses 150 μL (3 drops) of OC-FCa
Control, including a dead volume of 100 μL of a sample cup. For aduplicated measurement, it uses 200 μL (4 drops).
When the measurement value of OC-FCa Control (LV1/LV2/LV3) isnot within the control range set by each laboratory, new calibration
curve should be created.
Note: Volume of 1 drop from the vial of OC-FCa Control isapproximately 50 μL.
In-use Stability
OC-FCa Control is stable for 2 months after opening. The stability forthis 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 inrelation to the device shall be reported to the authorised
representative, the manufacturer, and the competent authority of theMember State in which the user and/or the patient is established.
EXPLANATION OF SYMBOLS

STORAGEOC-FCa Control is stable until the date printed on the label whenstored at 2-8 °C.

Date of issuance: 2022-05-26