# K163225: AFIAS iFOB with AFIAS-50

- Pathway: 510(k) (Traditional)
- Applicant: Immunostics Inc.,
- Decided: Aug 8, 2017 after 264 days
- Product code: OOX (Automated Occult Blood Analyzer)
- 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 K041408 (2004). 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)
- K132167: I-Chroma Ifob with I-Chroma Reader, Boditech Med, Inc. (2014) Summary page 4.

## Indications for use
AFIAS iFOB in conjunction with AFIAS 50 is a fluorescence immunoassay system for qualitative detection of fecal occult blood (FOB) in human fecal samples. AFIAS iFOB is an in vitro diagnostic test used by professional clinical laboratories and clinical reference laboratories for routine physical examination when gastrointestinal bleeding may be suspected. Intended users/operators for AFIAS iFOB is professional medical personnel.

Source page: https://510kreport.com/device/K163225
Methodology: https://510kreport.com/methodology