# K981661: Hemaprompt

- Pathway: 510(k) (Traditional)
- Applicant: Aerscher Diagnostics
- Decided: Sep 15, 1998 after 132 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. The FDA summary names no predicate by number.

## Indications for use
HemaPrompt is a guaiac-based in-vitro slide method for the qualitative detection of occult blood in feces by lay persons. It is a useful aid in the diagnosis or early detection of a number of gastro-intestinal disorders, and is recommended for use in monitoring for recurrences of previously treated bowel conditions, and in screening for colorectal cancer or for other sources of gastro-intestinal bleeding.

Source page: https://510kreport.com/device/K981661
Methodology: https://510kreport.com/methodology