# K063693: Forsure One Step Fecal Occult Blood (Fob) Screen Card Test

- Pathway: 510(k) (Traditional)
- Applicant: New Bay Bioresearch Co., Ltd.
- Decided: May 11, 2007 after 149 days
- Product code: KHE (Reagent, Occult Blood)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041202 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041202: Hemosure One-Step Fecal Occult Blood Test, W.H.P.M., Inc. (2004) Summary page 2.

## Recalls of this device
- Mar 21, 2011 · Not classified · Z-2110-2011: Potential for false negatives test results and negative/faint positive controls
- Mar 21, 2011 · Not classified · Z-2108-2011: Potential for false negatives test results and negative/faint positive controls
- Mar 21, 2011 · Not classified · Z-2111-2011: Potential for false negatives test results and negative/faint positive controls
- Mar 21, 2011 · Not classified · Z-2109-2011: Potential for false negatives test results and negative/faint positive controls

## Indications for use
Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is a rapid, immunochromatographic assay for the qualitative detection of intact hHb (human hemoglobin) in fecal specimens. It is a convenient and hygienic method for detecting human fecal occult blood, which may be indicative of gastrointestinal disease associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans. Forsure One Step Fecal Occult Blood (FOB) Screen Card Test is an immunological test for both professional and over the counter use.

Source page: https://510kreport.com/device/K063693
Methodology: https://510kreport.com/methodology