Instructions for Use
380364-A

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

OC-SENSOR Sample Diluent
for OC-SENSOR DIANA, PLEDIA, MICRO, io
for OC-SENSOR Ceres

EnglishWARNINGS AND PRECAUTIONSREF V-PH19
REF V-PH08

INTENDED USE

OC-SENSOR Sample Diluent is intended for use as a high concentration
sample diluent used together with OC-SENSOR FIT reagents and OC-FCaReagent on the automated immunochemical analysers [OC-SENSOR series]
to measure faecal haemoglobin and calprotectin.
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.
OC-FCa Reagent is in vitro diagnostic reagent intended for the quantitative
measurement of calprotectin, inflammatory protein, in faeces. The OC-FCa
Reagent aids in diagnostic and monitoring of inflammatory bowel diseases(IBD; e.g. ulcerative colitis, and Crohn’s disease) in conjunction with otherclinical findings. The test can be utilized in diagnostic aid and in monitoring for
symptomatic patients.
The tests are noninvasive, using stool/faeces as test sample. The reagents areused on the dedicated automated analysers by qualified personnel in clinicallaboratories and hospitals.

1. For in vitro diagnostic use only.
2. Do not use OC-SENSOR Sample Diluent for any purpose other than dilutionof high concentration samples.
3. Do not freeze.
4. Do not use OC-SENSOR Sample Diluent after the expiry date.
5. Air bubbles on the surface can cause an erroneous measurement. Thebubbles should be removed.
6. The test sample may contain pathogens. Handle with care. After use, allsamples and other materials must be considered as medical waste andproperly disposed of.
7. Dispose of used reagents and containers as medical waste in accordancewith local regulations.

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

EXPLANATIONS OF SYMBOLS

MATERIALS PROVIDED
Product code

Product nameContents

Compatible
analyser

V-PH19

OC-SENSOR
Sample Diluent

3 x 45 mL

DIANA, PLEDIA,MICRO, io

V-PH08

OC-SENSOR
Sample Diluent

2 x 20 mLCeres

MATERIALS REQUIRED BUT NOT PROVIDED

For Haemoglobin Measurement
OC-SENSOR FIT Latex Reagent, Buffer
OC-FIT Calibrator
OC-FIT Control
OC-Auto Sampling Bottle 3For Calprotectin Measurement
OC-FCa Reagent
OC-FCa Calibrator
OC-FCa Control
OC-Auto Sampling Bottle 3COMPOSITION

OC-SENSOR Sample Diluent is liquid and ready to use.
It contains buffer solution (HEPES; N-2-hydroxyethyl piperazine-N'-2ethanesulfonic acid).
The container is made of polyethylene (PE), the cap is made of polypropylene(PP), and the case is made of paper.

STORAGEThis product is stable up to the date printed on the label as long as it remains
unopened at a storage temperature of 2-8 °C.

PROCEDURE

Dilution procedure should be followed in the manner described in the user
manual of the automatic analysers.
[OC-SENSOR DIANA, OC-SENSOR PLEDIA]
Set a high concentration sample, an empty sample cup and a sample cup with
2 mL (or more) of the diluent on a dedicated rack. Dilution is performed
automatically before measurement on the analyser.
[OC-SENSOR MICRO, OC-SENSOR io]
Manually dilute high concentration samples with the diluent, add the diluted
sample in a sample cup and measure on the analyser.
[OC-SENSOR Ceres]Set the diluent (REF V-PH08) in the dedicated reagent slot on the analyser
with a cap open. Dilution is performed automatically before measurement on
the analyser.
Date of issuance: 2022-05-26