510(k) · Cleared

Cleared

H. Pylori Quik Chek

K181379510(k) TraditionalCleared Aug 21, 201889-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

Techlab, Inc. · LYR Helicobacter Pylori

Cleared on Aug 21, 2018 as substantially equivalent to K032222 (Meridian Bioscience, Inc., 2003) after an 89-day review. Its family tree reaches back 2 generations to 1998.

Decided: Aug 21, 2018
Review: 89 days
Class: Class I
Product code: LYR
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K983255 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK983255 Modification to: Premier Platinum HpsaMeridian Diagnostics, Inc. · 1998 · Recalled
1 generation backK032222 Immunocardstat HpsaMeridian Bioscience, Inc. · 2003
This deviceK181379 H. Pylori Quik ChekTechlab, Inc. · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K983255	Modification to: Premier Platinum Hpsa	Meridian Diagnostics, Inc.	1998	1
−1	K032222	Immunocardstat Hpsa	Meridian Bioscience, Inc.	2003	—
0 (this device)	K181379	H. Pylori Quik Chek	Techlab, Inc.	2018	—

FIG. 1 — Lineage of K181379, 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 LYR? 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 LYR device

#1 K232892 Hp Detect™ Stool Antigen ELISAscore 7.1 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 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
*	K032222	Immunocardstat Hpsa Summary page 6 …arison Table Similarities Item H. PYLORI QUIK CHEK™ ImmunoCard STAT!® HpSA (K032222) The TECHLAB® H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immu…	Meridian Bioscience, Inc.	2003	—

Also cleared against K032222: 1 other device →

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 14.7 years on median.
1 of the 2 ancestors has a recall of any class.
1 other device also cites its predicate K032222.

How does its category compare?

All LYR devices

LYR Helicobacter Pylori: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · LYR

2in 2023

2007high 4 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYR

86in 2018

2007high 86 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LYR

2in 2025

2007high 3 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LYR

2in 2023

2007high 4 (2016) · low 0 (2007)2025

MAUDE reports naming product code LYR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	2	0
2009	0	—	0	0
2010	0	—	1	1
2011	0	—	0	2
2012	2	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	2	—	0	2
2016	2	—	0	4
2017	0	—	0	1
2018	4	86	0	0
2019	1	—	0	0
2020	1	—	0	4
2021	0	—	0	1
2022	0	—	3	0
2023	2	—	1	2
2024	0	—	0	0
2025	0	—	2	0
2026	0	—	0	—

What is it indicated for?

Read the full statement (122 words)

The TECHLAB H. PYLORI QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the qualitative detection of Helicobacter pylori specific antigen in a single use cassette. It is intended for use with human fecal specimens to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment. The test can be used with unpreserved fecal specimens and fecal specimens preserved in transport media from patients suspected of H. pylori infection. Testing of patients to demonstrate loss of H. pylori antigen following treatment should be performed no sooner than 4 weeks after completion of the treatment regimen. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K181379 · printed Nov 5, 2026

Cite this page

510(k) Report. “K181379: H. Pylori Quik Chek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181379

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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