510(k) · Cleared

Cleared

Premier Platinum Hpsa Plus, Models 601396, 601480

K053335510(k) TraditionalCleared Mar 10, 200699-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. · LYR Helicobacter Pylori

Cleared on Mar 10, 2006 as substantially equivalent to K980076 (Meridian Diagnostics, Inc., 1998) and 1 other predicate after a 99-day review. Its family tree reaches back 1 generation to 1998. 6 later devices descend from it.

Decided: Mar 10, 2006
Review: 99 days
Class: Class I
Product code: LYR
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K980076 (1998). 2 ancestors in all. 6 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK980076 Premier Platinum HpsaMeridian Diagnostics, Inc. · 1998
This deviceK053335 Premier Platinum Hpsa Plus, Models 601396, 601480Meridian Bioscience, Inc. · 2006
Descendant · cites it directly · 3 of its ownK182559 PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc. · 2018
Descendant · 2 generations on · 0 of its ownK232892 Hp Detect™ Stool Antigen ELISABiomerica, Inc. · 2023
Descendant · 2 generations on · 0 of its ownK230901 Premier HpSA Flex (619096)Meridian Bioscience, Inc. · 2023
Descendant · 2 generations on · 0 of its ownK192817 Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc. · 2020
Descendant · cites it directly · 0 of its ownK181464 LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc. · 2018

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2018high 3 (2018) · low 0 (2019)2026

Most influential descendants

Showing 5 of 6 · See all

K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc. · 2018 · cites it directly3descendants
K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc. · 2023 · 2 generations on0descendants
K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc. · 2023 · 2 generations on0descendants
K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc. · 2020 · 2 generations on0descendants
K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc. · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K980076	Premier Platinum Hpsa	Meridian Diagnostics, Inc.	1998	—
0 (this device)	K053335	Premier Platinum Hpsa Plus, Models 601396, 601480	Meridian Bioscience, Inc.	2006	—
+1	K182559	PREMIER Platinum HpSA PLUS	Meridian Bioscience, Inc.	2018	—
+2	K232892	Hp Detect™ Stool Antigen ELISA	Biomerica, Inc.	2023	—
+2	K230901	Premier HpSA Flex (619096)	Meridian Bioscience, Inc.	2023	—
+2	K192817	Curian HpSA, Curian Analyzer	Meridian Bioscience, Inc.	2020	—
+1	K181464	LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set	DiaSorin, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	3	0
2020	1	0
2023	2	0

FIG. 1 — Lineage of K053335, 1998–2023Source: 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? (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
*	K980076	Premier Platinum Hpsa Summary page 1 …YR, CFR section 866.3110 Predicate device to which this device is being compared: Premier Platinum HpSA (Meridian Bioscience, Inc., Cincinnati, OH) (K980076, K983255) Device description: Premier Platinum HpSA PLUS is an in vitro diagnostic, microwell-based, enzyme- linked immunoassay f…	Meridian Diagnostics, Inc.	1998	—
*	K983255	Modification to: Premier Platinum Hpsa Summary page 1 …ection 866.3110 Predicate device to which this device is being compared: Premier Platinum HpSA (Meridian Bioscience, Inc., Cincinnati, OH) (K980076, K983255) Device description: Premier Platinum HpSA PLUS is an in vitro diagnostic, microwell-based, enzyme- linked immunoassay for the de…	Meridian Diagnostics, Inc.	1998	1

What descends from it? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K182559	PREMIER Platinum HpSA PLUS	Meridian Bioscience, Inc.	2018	3
K181464	LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set	DiaSorin, Inc.	2018	0
K181400	H. Pylori 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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K182559 (Meridian Bioscience, Inc., 2018) has gone furthest, with 3 descendants of its own.

How does its category compare?

All LYR devices

LYR Helicobacter Pylori: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

The Premier Platinum HpSA PLUS enzyme immunoassay (EIA) is an in vitro qualitative procedure for

the detection of Helicobacter pylor antigens in human stool. Test results are intended to aid in the

diagnosis of H.pylori infection and to monitor response during and post-therapy in patients. Accepted

medical practice recommends that testing by any current method, to confirm eradication, be done at

least four weeks following completion of therapy.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053335 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053335: Premier Platinum Hpsa Plus, Models 601396, 601480.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053335

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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