# K980671: Coloscreen-ES

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: May 12, 1998 after 81 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
ColoScreen—-ES is designed for the qfialitative detection of fecal occult blood. It is an aid in the diagnosis of gastrointestinal disorders such as hemorrhoids, diverticulitis, fissures, colitis or colorectal cancer. The test can be used in mass health screens, doctors offices or hospitals.

Source page: https://510kreport.com/device/K980671
Methodology: https://510kreport.com/methodology