# K063673: Innovacon Flipcard Fecal Occult Blood Test Device

- Pathway: 510(k) (Traditional)
- Applicant: Innovacon, Inc.
- Decided: Mar 5, 2007 after 84 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Hemoccult® ICT Immunological Fecal Occult Blood Test: named in the summary without a submission number

## Indications for use
The Innovacon Flipcardrm Fecal Occult Blood Test Device is intended for rapid qualitative detection of human hemoglobin in fecal samples. Fecal occult blood tests are used as a screening tool for detecting lower gastrointestinal (GI) bleeding that may be related to iron deficiency anemia, peptic ulcer, ulcerative colitis, polyp and colorectal cancer. The FlipcardTM FOBT is recommended for use by health professionals in routine physical examinations and in monitoring for GI bleeding in patients in hospitals or at physician's offices.

Source page: https://510kreport.com/device/K063673
Methodology: https://510kreport.com/methodology