# K954996: Trend Amebiasis (E.Histolytica) Serological Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Trend Scientific, Inc.
- Decided: Aug 8, 1996 after 281 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 its predicate without a number.
- (no number) Original TREND Amebiasis (Entamoeba histolytica) Serological ELISA Test System: named in the summary without a submission number

## Indications for use
The intended use of the device is for the qualitative and/or quantitative determination of serum IgG antibodies to Entamoeba histolytica using an Enzyme-Linked Immunosorbent Assay (ELISA) technique.

Source page: https://510kreport.com/device/K954996
Methodology: https://510kreport.com/methodology