# K110309: Fob One Step Rapid Test

- Pathway: 510(k) (Traditional)
- Applicant: Orient Gene Biotech
- Decided: Sep 14, 2011 after 224 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.
1 later device descends from it; 1 cites it directly.
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 1.

## Most influential descendants
- K162333: Wondfo One Step Fecal Occult Blood (FOB) Test (2017), 0 descendants of its own

## Indications for use
The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens. The device is suitable for use in laboratories and physician's offices as well as for home use.

Source page: https://510kreport.com/device/K110309
Methodology: https://510kreport.com/methodology