# K052598: Immocare

- Pathway: 510(k) (Traditional)
- Applicant: Care Diagnostic, Inc.
- Decided: Mar 16, 2006 after 176 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The IunMoCARE test is a rapid, immunochromatographic assay for the qualitative detection of intact hHB (human hemoglobin) in focal specimens- It is a convenient and hygienic inethod for detecting human fecal occult blood, which may be indicative of gastrointestinal diseases associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans_ ImmoCARE ® is an immunological test for both professional and over the counter use..

Source page: https://510kreport.com/device/K052598
Methodology: https://510kreport.com/methodology