510(k) · Cleared

Cleared

Immunocard Stat Campy, Model 751530

K090700510(k) TraditionalCleared May 28, 200972-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 May 28, 2009 as substantially equivalent to K982315 (Alexon - Trend, Inc., 1998) after a 72-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.

Decided: May 28, 2009
Review: 72 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 deviceK090700 Immunocard Stat Campy, Model 751530Meridian Bioscience, Inc. · 2009
Descendant · cites it directly · 0 of its ownK173217 Campylobacter Quik ChekTechlab, Inc. · 2018

Most influential descendants

Showing 1 of 1 · See all

K173217Campylobacter Quik 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)	K090700	Immunocard Stat Campy, Model 751530	Meridian Bioscience, Inc.	2009	—
+1	K173217	Campylobacter Quik Chek	Techlab, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K090700, 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? (2)

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 …apid immunochromatographic assay for Campylobacter Classification name: Cam pylobacter ssp. LOP, CFR section 866.311 0 Predicate device: K982315, ProSpecT Campylobacter EIA Reference comparator Bacterial culture Description of the ImmunoCard STAT! CAMPY is an immu…	Alexon - Trend, Inc.	1998	1
*	—	Premier CAMPY Named without a submission number			—

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
K173217	Campylobacter Quik 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, K173217 (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?

ImmunoCard STAT! CAMPY is an immunochromatographic rapid test for the qualitative detection of specific Campylobacter antigens in human stool. ImmunoCard STAT! CAMPY detects C. jejuni and C. coli in human stool, where stool may be either unpreserved or preserved in Cary-Blair-based transport media. Test results are to be used in conjunction with information available from the patient's clinical evaluation and other diagnostic procedures.

ImmunoCard STAT! CAMPY is not intended for point-of-care use. The device is intended for use in hospital, reference, regional, private or state laboratory settings.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090700 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090700: Immunocard Stat Campy, Model 751530.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090700

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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