# K955895: E. Histolytica Test

- Pathway: 510(k) (Traditional)
- Applicant: Techlab, Inc.
- Decided: Aug 30, 1996 after 248 days
- Product code: KHW (Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.)
- Device class: 2
- Regulation: 21 CFR 866.3220
- 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
The E. histolytica Test can be used to detect adhesin (also referred to as galactose-inhibitable lectin) produced by strains of E. histolytica. It does not cross-react with the adhesin from E. dispar (formerly known as nonpathogenic E. histolytica). The test can be used to detect the adhesin in fecal specimens from persons suspected of having amebiasis.

Source page: https://510kreport.com/device/K955895
Methodology: https://510kreport.com/methodology