# K170728: E. Histolytica Quik Chek

- Pathway: 510(k) (Traditional)
- Applicant: Techlab, Inc.
- Decided: Jun 7, 2017 after 90 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
Longest line of descent: 1 generation back to K994101 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994101: E. Histolytica II, Techlab, Inc. (1999) Summary page 6.

## Indications for use
The TECHLAB E. HISTOLYTICA QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of adhesin from Entamoeba histolytica in a single use cassette. It is intended for use with human fecal specimens from patients with diarrhea or dysentery as an aid in the diagnosis of E. histolytica gastrointestinal infection. Test results should be considered in conjunction with patient history.

Source page: https://510kreport.com/device/K170728
Methodology: https://510kreport.com/methodology