510(k) · Cleared

Cleared

Campylobacter Chek

K173219510(k) TraditionalCleared Jan 22, 2018111-day reviewClass I21 CFR 866.3110

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Jan 22, 2018 as substantially equivalent to K083464 (Meridian Bioscience, Inc., 2009) after a 111-day review. Its family tree reaches back 2 generations to 1998.

Decided: Jan 22, 2018
Review: 111 days
Class: Class I
Product code: LQP
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K982315 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK982315 Prospect Campylobacter Microplate AssayAlexon - Trend, Inc. · 1998 · Recalled
1 generation backK083464 Premier Campy, Model 618096Meridian Bioscience, Inc. · 2009
This deviceK173219 Campylobacter ChekTechlab, Inc. · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K982315	Prospect Campylobacter Microplate Assay	Alexon - Trend, Inc.	1998	1
−1	K083464	Premier Campy, Model 618096	Meridian Bioscience, Inc.	2009	—
0 (this device)	K173219	Campylobacter Chek	Techlab, Inc.	2018	—

FIG. 1 — Lineage of K173219, 1998–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LQP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LQP device

#1 K210976 Curian Campyscore 2.6 · 1 generation · no Class I recall
#2 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K083464	Premier Campy, Model 618096 Summary page 6 …Item Device Predicate K173219 K083464 Indications for use The CAMPYLOBACTER CHEK Premier CAMPY enzyme tes…	Meridian Bioscience, Inc.	2009	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All LQP devices

LQP Campylobacter Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · LQP

2in 2021

2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LQP

Too few LQP 510(k)s in any year since 2007 to give a median.

Recalls per year · LQP

No recall names LQP since 2007.

Adverse event reports per year · LQP

No MAUDE report names LQP since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	2	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	2	—	0
2019	2	—	0
2020	0	—	0
2021	2	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The CAMPYLOBACTER CHEK™ test is an enzyme immunoassay for the qualitative detection of a Campylobacter-specific antigen in human fecal specimens. The CAMPYLOBACTER 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K173219 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173219: Campylobacter Chek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173219

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026