# K041202: Hemosure One-Step Fecal Occult Blood Test

- Pathway: 510(k) (Traditional)
- Applicant: W.H.P.M., Inc.
- Decided: Aug 12, 2004 after 97 days
- Product code: KHE (Reagent, Occult Blood)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Instant-View Fecal Occult Blood (FOB) II Test (Cassette): named in the summary without a submission number

## Most influential descendants
- K063693: Forsure One Step Fecal Occult Blood (Fob) Screen Card Test (2007), 0 descendants of its own

## Recalls of this device
- Feb 27, 2019 · Class III · Z-1080-2019: Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the packaging being too similar to domestically sourced products under the same branded label.

## Indications for use
The Hemosure™ One-Step Fecal Occult Blood (FOB) Test is an immunochemical device intended for the qualitative detection of Fecal Occult Blood by laboratories or physicians offices. It is useful to determine gastrointestinal (GI) bleeding found in a number of GI disorders, e.g. diverticulitis, colitis, polyps, and colorectal cancer.

Source page: https://510kreport.com/device/K041202
Methodology: https://510kreport.com/methodology