510(k) · Cleared

Cleared

Premier Campy, Model 618096

K083464510(k) TraditionalCleared Jan 30, 200967-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

Meridian Bioscience, Inc. · LQP Campylobacter Spp.

Cleared on Jan 30, 2009 as substantially equivalent to K982315 (Alexon - Trend, Inc., 1998) after a 67-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.

Decided: Jan 30, 2009
Review: 67 days
Class: Class I
Product code: LQP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K982315 (1998). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK982315 Prospect Campylobacter Microplate AssayAlexon - Trend, Inc. · 1998 · Recalled
This deviceK083464 Premier Campy, Model 618096Meridian Bioscience, Inc. · 2009
Descendant · cites it directly · 0 of its ownK173219 Campylobacter ChekTechlab, Inc. · 2018

Most influential descendants

Showing 1 of 1 · See all

K173219Campylobacter ChekTechlab, Inc. · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K083464, 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

Get a 510(k) Report

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
*	K982315	Prospect Campylobacter Microplate Assay Summary page 1 …ier CAMPY Common name: EIA for Campylobacter Classificationname: Campylobacter ssp. LOP, CFR section 866.311 0 Predicate device: K98231 5, ProSpecT Campylobacter EIA Reference comparator Bacterial culture Description of the Premier CAMPY is an in vitro diagn…	Alexon - Trend, Inc.	1998	1

Also cleared against K982315: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K173219	Campylobacter Chek	Techlab, Inc.	2018	0

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?

Its one ancestor has a recall.
Of its descendants, K173219 (Techlab, Inc., 2018) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K982315.

How does its category compare?

All LQP devices

LQP Campylobacter Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?

Premier CAMPY enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of specific Campylobacter antigens in stool samples from patients with signs and symptoms of gastroenteritis. Premier CAMPY detects C. jejuni and C. coli in human stool that may be either unpreserved or preserved in Cary Blair-based transport media. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.

Premier CAMPY is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083464 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083464: Premier Campy, Model 618096.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083464

Report an extraction error

Are you the manufacturer?

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