510(k) · Cleared

Cleared

Vstrip H. pylori Antigen Rapid Test

K183573510(k) TraditionalCleared Mar 14, 201983-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

Panion & BF Biotech, Inc. · LYR Helicobacter Pylori

Cleared on Mar 14, 2019 as substantially equivalent to K032222 (Meridian Bioscience, Inc., 2003) after an 83-day review. Its family tree reaches back 2 generations to 1998.

Decided: Mar 14, 2019
Review: 83 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 deviceK183573 Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc. · 2019

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)	K183573	Vstrip H. pylori Antigen Rapid Test	Panion & BF Biotech, Inc.	2019	—

FIG. 1 — Lineage of K183573, 1998–2019Source: 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 5 …FR 866.3110) Regulatory Class: Class I Product Code: LYR Predicate Device: ImmunoCard STAT!® HpSA® [K032222] 4. Device Description The Vstrip® H.pylori Antigen Rapid Test (Vstrip®) is a Helicobacter pylori (H. pylori) antige…	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 21 years and passes through 3 companies; a new generation was cleared every 15.3 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. 2019, 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?

Vstrip® H.pylori Antigen Rapid Test is a single use immunochromatographic assay for the qualitative detection of H. pylori antigen in unpreserved human stool specimens. Test results are intended to aid in the initial diagnosis and treatment of H. pylori infection. 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/K183573 · printed Nov 4, 2026

Cite this page

510(k) Report. “K183573: Vstrip H. pylori Antigen Rapid Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183573

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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