# K992759: Colon Alert Test

- Pathway: 510(k) (Traditional)
- Applicant: Immunostics Inc.,
- Decided: Dec 6, 1999 after 111 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
COLON ALERT is a rapid, convenient and non-offensive aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the presence of occuit blood in the stool. This test is “FOR OVER-THE-COUNTER USE".

Source page: https://510kreport.com/device/K992759
Methodology: https://510kreport.com/methodology