# K173217: Campylobacter Quik Chek

- Pathway: 510(k) (Traditional)
- Applicant: Techlab, Inc.
- Decided: Jan 22, 2018 after 111 days
- Product code: LQP (Campylobacter Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K982315 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090700: Immunocard Stat Campy, Model 751530, Meridian Bioscience, Inc. (2009) Summary page 6.

## Indications for use
The CAMPYLOBACTER QUIK CHEK™ test is a rapid membrane enzyme-linked immunosorbent assay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER QUIK CHEK™ test is designed to detect C. jejuni and C. coli from patients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

Source page: https://510kreport.com/device/K173217
Methodology: https://510kreport.com/methodology