# K060953: Occultech Fecal Occult Blood Rapid Test

- Pathway: 510(k) (Traditional)
- Applicant: Yd Diagnostics Corp.
- Decided: Sep 18, 2006 after 165 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: 2 generations back to K880499 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021423: Instant-View Fecal Occult Blood Rapid Test, Alfa Scientific Designs, Inc. (2002) Summary page 1.

## Indications for use
The OcculTech Occult Blood Rapid Test is a card type rapid test and an immunochromatography based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices. It is useful in determining gastrointestinal bleeding found in a number of gastrointestinal disorders (e.g. diverticulitis, colitis, polyps and colorectal cancer). This device is recommended for use in routine physical examinations, when hospital patients are first admitted, hospital monitoring for bleeding in patients, and screening for colorectal cancer or gastrointestinal bleeding from any source.

Source page: https://510kreport.com/device/K060953
Methodology: https://510kreport.com/methodology