Product Code: LQP FDA class 1 21 CFR 866.3110

Campylobacter Spp.

Microbiology

Campylobacter species diagnostic reagents are in vitro diagnostic products used to detect and identify Campylobacter organisms in clinical specimens, aiding in the diagnosis of bacterial gastroenteritis caused by these pathogens. They are classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LQP, regulated under 21 CFR 866.3110, within the Microbiology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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FEI Numbers

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Basic Information

Product Code: LQP
Device Class: FDA class 1
Regulation Number: 866.3110
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 12 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K210976	Curian Campy	Dec 23, 2021	Substantially Equivalent	Meridian Bioscience, Inc.
K211342	Sofia 2 Campylobacter FIA	Nov 23, 2021	Substantially Equivalent	Quidel Corporation
K191456	Campylobacter Quik Chek	Jun 20, 2019	Substantially Equivalent	Techlab, Inc.
K191442	Campylobacter Chek	Jun 20, 2019	Substantially Equivalent	Techlab, Inc.
K173219	CAMPYLOBACTER CHEK	Jan 22, 2018	Substantially Equivalent	Techlab, Inc.
K173217	CAMPYLOBACTER QUIK CHEK	Jan 22, 2018	Substantially Equivalent	Techlab, Inc.
K090700	IMMUNOCARD STAT CAMPY, MODEL 751530	May 28, 2009	Substantially Equivalent	Meridian Bioscience, Inc.
K083464	PREMIER CAMPY, MODEL 618096	Jan 30, 2009	Substantially Equivalent	Meridian Bioscience, Inc.
K982315	PROSPECT CAMPYLOBACTER MICROPLATE ASSAY	Nov 18, 1998	Substantially Equivalent	Alexon - Trend, Inc.
K880389	MERITEC(TM)-CAMPY (JCL)	Apr 12, 1988	Substantially Equivalent	Meridian Diagnostics, Inc.
K864027	BBL CAMPYSLIDE(TM) TEST	Dec 11, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K862814	COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI	Sep 30, 1986	Substantially Equivalent	Institute Virion , Ltd.