# K121397: Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: SEKISUI Diagnostics, LLC
- Decided: Dec 28, 2012 after 233 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 OSOM iFOBT Control Kit is intended for use in quality control testing with the OSOM iFOB Test.

Source page: https://510kreport.com/device/K121397
Methodology: https://510kreport.com/methodology