# K173212: Instant-view-PLUS immunochemical Fecal Occult Blood Test

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Scientific Designs, Inc.
- Decided: Feb 15, 2018 after 136 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070660: Instant-View Fecal Occult Blood (Fob) Rapid Test, Alfa Scientific Designs, Inc. (2007) Summary page 4.
- K021423: Instant-View Fecal Occult Blood Rapid Test, Alfa Scientific Designs, Inc. (2002) Summary page 4.

## Indications for use
The Instant-view-plus™ Immunochemical Fecal Occult Blood Test is a qualitative immunoassay for detection of Fecal Occult Blood. It is intended for professional and over the counter use.

Source page: https://510kreport.com/device/K173212
Methodology: https://510kreport.com/methodology