# K070660: Instant-View Fecal Occult Blood (Fob) Rapid Test

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Scientific Designs, Inc.
- Decided: Jun 21, 2007 after 104 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 K880499 (1988). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880499: Hemoccult Sensitive Test, Smithkline Diagnostics, Inc. (1988) Summary page 1.

## Most influential descendants
- K110309: Fob One Step Rapid Test (2011), 1 descendant of its own
- K173212: Instant-view-PLUS immunochemical Fecal Occult Blood Test (2018), 0 descendants of its own
- K162333: Wondfo One Step Fecal Occult Blood (FOB) Test (2017), 0 descendants of its own

## Indications for use
The INSTANT-VIEW Fecal Occult Blood (FOB) Self-Test is a qualitative 'mxnunoassay for the detection of Fecal Occult Blood by non-professional, lay individuals as a self-test product. Measurement of FOB is useful as an aid to detect human blood in stool as found in a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps and colorectal cancer. It is intended for over the counter use. The Fecal Occult Blood (FOB) Self-Test is a qualitative immunoassay for the detection of Fecal Occult Blood by non-professional, lay individuals as a self-test product. Measurement of FOB is useful as an aid to detect human blood in stool as found in a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps and colorectal cancer. It is intended for over the counter use.

Source page: https://510kreport.com/device/K070660
Methodology: https://510kreport.com/methodology