OC-FIT Control
LV1 LV2 LV3 REF V-PH53 REF V-PH54 REF|V-PH59 INTENDED USE OC-FIT Control LV1/LV2/LV3 are intended for use as an internal quality control in faecal immunochemical tests for haemoglobin. They are especially compatible with OC-SENSOR FIT on the automated reagents to measure  faecal immunochemical analysers [OC-SENSOR series] haemoglobin. OC-SENSOR FIT reagents are in vitro diagnostic reagents intended for the quantitative 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 and monitoring for symptomatic patients. The test is noninvasive, using automated analysers by qualified personnel in clinical laboratories and hospitals.
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
REAGENTS
OC-FIT Control is liquid and ready to use requiring no preparation. OC-FIT Control LV1 OC-FIT Control LV2 OC-FIT Control LV3
2 × 5 mL 2 × 5 mL 2 × 5 mL The haemoglobin concentration range is printed on the labels of a bottle. STORAGE OC-FIT Control is stable until the date printed on the label when stored at 2- IFU on our website / IFU sul nostro sito web / IFU en nuestro sitio web / IFU sur notre site web / IFU auf unserer Website https://www.eiken.co.jp/en/ifu SSP available in EUDAMED English
WARNINGS AND PRECAUTIONS
For in vitro diagnostic use only. 2i Do not freeze this product. Do not use expired products 4. sample Air bubbles on the surface of the product after being added into cups can result in erroneous measurement. The bubbles should be removed. 5. OC-FIT Control uses material derived from human blood. Only blood testing negative for HBs antigens, HIV (HIV-1 and HIV-2) antibodies and HCV 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. 6. When used on the OC-SENSOR series analysers, OC-FIT Control must be used with OC-FIT Calibrator (REF V-PH51, V-PH52, V-PH02) dedicated to each analyser. 7. 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 control refrigerated when not in use. In-use stability can be altered if the instruction is not followed.
PROCEDURE
Minimum requirement is to analyse the OC-FIT Control LV1 and LV2 before sample analysis on a daily basis. Analyse OC-FIT Control LV3 as required. Follow the detailed measurement procedure in the user manual of the automatic analysers. Add an appropriate amount of OC-FIT 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-FIT Control, including a dead volume of 100 μL of a sample cup. For a duplicated measurement, it uses 200 µL (4 drops). When the measurement value of OC-FIT Control (LV1/LV2/LV3) is not within the control range set by each laboratory, new calibration curve should be created. Note: Volume of 1 drop from the vial of OC-FIT Control is approximately 50 μL. In-use stability OC-FIT Control is stable for 2 months after opening. The stability for this period is kept if it is capped properly and put back in the refrigerator when not in use. In-use stability can be altered in case of contamination, evaporation and/or storage at improper temperatures.
NOTICE
In case of occurrence of any serious incident that has occurred in relation to the device shall be reported to the authorised representative, the manufacturer, and the competent authority of the Member State in which the user and/or the patient is established. EXPLANATION OF SYMBOLS 8 °C.