# K030216: Coloncare

- Pathway: 510(k) (Traditional)
- Applicant: Care Products, Inc.
- Decided: Apr 2, 2003 after 71 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
ColonCARE is a rapid, ConvCniQlf hygienic and highly sensitive (0.05 pg h€€b/ml)method for the qualitative detection of occult blood in fixes, which may be indicative of gaslrointestinal diseases associatedwith b l e w such as colorectal Carcinoma, Crohn’s disease, ulcerative colitis, and colon polyp: T h e test is recommended for use in the home or in medical hcilities as a screening test for colorectal a c e or gastrointestinal bleeding h m any some.

Source page: https://510kreport.com/device/K030216
Methodology: https://510kreport.com/methodology