# K080812: Hemoccult Ict

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jun 25, 2008 after 93 days
- Product code: KHE (Reagent, Occult Blood)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: 2 (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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K910666: Vitek Anaerobe Identification Card, Modification, Vitek Systems, Inc. (1991). Our reading of the summary gave K910666, FDA’s number for Vitek Anaerobe Identification Card, Modification (Vitek Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Hemoccult ICT (formerly FlexSure OBT)”. Kept off the family tree.

## Most influential descendants
- K101831: Enterix Insurefit Fob Controls, Model 16800 (2010), 0 descendants of its own

## Recalls of this device
- Jul 17, 2013 · Class II · Z-1997-2013: Beckman Coulter has received a customer complaint that suggests trending of positive results has increased from approximately 4% to 1 0%. As a result of our investigation, Beckman Coulter has confirme
- Jul 16, 2013 · Class II · Z-2197-2013: The products may have been stored at temperatures outside their required storage conditions.

## Indications for use
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples. Fecal occult blood tests are useful screening aids for detecting primarily lower gastrointentinal (g.i.) disorders that may be related to iron deficiency anemia, diverticulitis, ulcerative colitis, polyps, adenomas, colorectal cancers or other g.i. lesions that can bleed. Hemoccult ICT is recommended for use by health professionals as part of routine physical examinations or when lower g.i. disorders are suspected.

Source page: https://510kreport.com/device/K080812
Methodology: https://510kreport.com/methodology