# K143325: OC-Light S FIT

- Pathway: 510(k) (Traditional)
- Applicant: Eiken Chemical Co., Ltd.
- Decided: Aug 20, 2015 after 273 days
- Product code: KHE (Reagent, Occult Blood)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041297 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041297: Polymedco OC Light Fobt Test, Polymedco, Inc. (2004) Summary page 4.

## Indications for use
OC-Light S FIT (Fecal Immunochemical Test, also known as iFOBT, immunochemical fecal occult blood test) is an qualitative test intended for the immunochemical detection of fecal occult blood (FOB) in feces by professional laboratories and physician office laboratories. Measurement of FOB is useful as an aid to detect blood in stool when gastrointestinal (GI) bleeding may be suspected. OC-Light S FIT is recommended for use in routine physical examinations.

Source page: https://510kreport.com/device/K143325
Methodology: https://510kreport.com/methodology