510(k) · Cleared
ClearedPREMIER Platinum HpSA PLUS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Bioscience, Inc. · LYR Helicobacter Pylori
Cleared on Nov 5, 2018 as substantially equivalent to K053335 (Meridian Bioscience, Inc., 2006) after a 49-day review. Its family tree reaches back 2 generations to 1998. 3 later devices descend from it.
- Decided
- Nov 5, 2018
- Review
- 49 days
- Class
- Class I
- Product code
- LYR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980076 (1998). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK980076 Premier Platinum HpsaMeridian Diagnostics, Inc. · 1998
- 1 generation backK053335 Premier Platinum Hpsa Plus, Models 601396, 601480Meridian Bioscience, Inc. · 2006
- This deviceK182559 PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK232892 Hp Detect™ Stool Antigen ELISABiomerica, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK230901 Premier HpSA Flex (619096)Meridian Bioscience, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK192817 Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980076 | Premier Platinum Hpsa | Meridian Diagnostics, Inc. | 1998 | — |
| −1 | K053335 | Premier Platinum Hpsa Plus, Models 601396, 601480 | Meridian Bioscience, Inc. | 2006 | — |
| 0 (this device) | K182559 | PREMIER Platinum HpSA PLUS | Meridian Bioscience, Inc. | 2018 | — |
| +1 | K232892 | Hp Detect™ Stool Antigen ELISA | Biomerica, Inc. | 2023 | — |
| +1 | K230901 | Premier HpSA Flex (619096) | Meridian Bioscience, Inc. | 2023 | — |
| +1 | K192817 | Curian HpSA, Curian Analyzer | Meridian Bioscience, Inc. | 2020 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K053335 | Premier Platinum Hpsa Plus, Models 601396, 601480Summary page 4…bacter fetus serological reagents (21 CFR 866.3110, Product Code LYR) Predicate Device: PREMIER Platinum HpSA® PLUS K053335 Device Description The PREMIER Platinum HpSA® PLUS test is a microwell-based enzyme immunoassay that detects H. pylori antigens… | 2006 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 companies; a new generation was cleared every 12.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K232892 (Biomerica, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K053335.
How does its category compare?
All LYR devicesLYR 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
2026 to Oct 25, outlined.
Median 510(k) review, days · LYR
86in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYR
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYR
2in 2023
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 pylori 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/K182559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182559: PREMIER Platinum HpSA PLUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182559
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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