# K041297: Polymedco OC Light Fobt Test

- Pathway: 510(k) (Traditional)
- Applicant: Polymedco, Inc.
- Decided: Aug 12, 2004 after 90 days
- Product code: KHE (Reagent, Occult Blood)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K143325: OC-Light S FIT (2015), 0 descendants of its own
- K101831: Enterix Insurefit Fob Controls, Model 16800 (2010), 0 descendants of its own

## Recalls of this device
- Feb 12, 2013 · Class II · Z-1059-2013: The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a po

## Indications for use
The Polymedco OC Light FOB test is an immunological test intended for the detection of fecal occult blood in feces by professional laboratories and physician office labs. The test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal (GI) disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer. The OC Light test is recommended for use in 1) routine physical examinations 2) monitoring for bleeding in patients 3) screening for colorectal cancer or gastrointestinal bleeding

Source page: https://510kreport.com/device/K041297
Methodology: https://510kreport.com/methodology