# K994101: E. Histolytica II

- Pathway: 510(k) (Special)
- Applicant: Techlab, Inc.
- Decided: Dec 21, 1999 after 15 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K170728: E. Histolytica Quik Chek (2017), 0 descendants of its own

## Indications for use
The E. histolytica I is an enzyme immunoassay for the rapid detection of the adhesin of E. histolytica in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea or dysentery to determine the presence of E. histolytica gastrointestinal infection. The test can be used for fecal specimens submitted for routine clinical testing from adults or children. Conventional microscopy is not a prerequisite for use of the test. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K994101
Methodology: https://510kreport.com/methodology