# K021423: Instant-View Fecal Occult Blood Rapid Test

- Pathway: 510(k) (Abbreviated)
- Applicant: Alfa Scientific Designs, Inc.
- Decided: Jun 17, 2002 after 45 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; 3 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
- K173212: Instant-view-PLUS immunochemical Fecal Occult Blood Test (2018), 0 descendants of its own
- K121397: Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test Kit (2012), 0 descendants of its own
- K060953: Occultech Fecal Occult Blood Rapid Test (2006), 0 descendants of its own

## Indications for use
This Fecal Occult Blood (FOB) Rapid Test is an immunochemical device intended for the qualitative detection of Fecal Occult Blood by laboratories or physicians offices. It is useful to determining gastrointestinal (GI) bleeding found in a number of gastrointestinal (GI) disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer. This test is recommended for use in 1) routine physical examinations, when hospital patients are first admitted, 2) hospital monitoring for bleeding in patients, 3) screening for colorectal cancer or gastrointestinal bleeding from any source.

Source page: https://510kreport.com/device/K021423
Methodology: https://510kreport.com/methodology