# K162333: Wondfo One Step Fecal Occult Blood (FOB) Test

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Wondfo Biotech Co., Ltd.
- Decided: May 14, 2017 after 265 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: 3 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)
- K110309: Fob One Step Rapid Test, Orient Gene Biotech (2011) Summary page 4.

## Indications for use
Wondfo One Step Fecal Occult Blood Test is a rapid test for the qualitative detection of human occult blood in feces. It is used as an aid in the diagnosis of gastrointestinal(GI) bleeding. The device is suitable for use in laboratories and physician’s offices as well as for over the counter use. For in vitro diagnostic use only. For prescription use and over the counter use.

Source page: https://510kreport.com/device/K162333
Methodology: https://510kreport.com/methodology