# K972763: Hemaprompt

- Pathway: 510(k) (Traditional)
- Applicant: Aerscher Diagnostics
- Decided: Oct 20, 1997 after 88 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 and gastric aspirate or vomitus by medical professionals only. For fecal testing, it is a useful aid in the diagnosis of a number of gastro-intestinal disorders, and is recommended for use in 1) routine physical examinations 2) routine hospital testing 3) screening for colorectal cancer or gastro-intestinal bleeding from any other source. For the testing of gastric contents it is used for the early detection of occult blood in conditions such as gastric trauma, gastric or duodenal ulceration, gastric cancer, esophageal varices, situations of likely exogenous or endogenous gastritis, leukemia, and hereditary telangiectasia These conditions may be encountered in the emergency room, recovery room or intensive care.

Source page: https://510kreport.com/device/K972763
Methodology: https://510kreport.com/methodology