510(k) · Cleared
Recalled · 2002Modification to: Premier Platinum Hpsa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Diagnostics, Inc. · LYR Helicobacter Pylori
Cleared on Dec 17, 1998 after a 93-day review. The FDA summary names its predicate without a number. 10 later devices descend from it. It has been recalled once.
- Decided
- Dec 17, 1998
- Review
- 93 days
- Class
- Class I
- Product code
- LYR
- Recalls
- 1
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK983255 Modification to: Premier Platinum HpsaMeridian Diagnostics, Inc. · 1998
- Descendant · cites it directly · 6 of its ownK053335 Premier Platinum Hpsa Plus, Models 601396, 601480Meridian Bioscience, Inc. · 2006
- Descendant · 2 generations on · 3 of its ownK182559 PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK032222 Immunocardstat HpsaMeridian Bioscience, Inc. · 2003
- Descendant · 3 generations on · 0 of its ownK232892 Hp Detect™ Stool Antigen ELISABiomerica, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK230901 Premier HpSA Flex (619096)Meridian Bioscience, Inc. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K053335Premier Platinum Hpsa Plus, Models 601396, 601480Meridian Bioscience, Inc. · 2006 · cites it directly6descendants
- K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc. · 2018 · 2 generations on3descendants
- K032222Immunocardstat HpsaMeridian Bioscience, Inc. · 2003 · cites it directly2descendants
- K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc. · 2023 · 3 generations on0descendants
- K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983255 | Modification to: Premier Platinum Hpsa | Meridian Diagnostics, Inc. | 1998 | — |
| +1 | K053335 | Premier Platinum Hpsa Plus, Models 601396, 601480 | Meridian Bioscience, Inc. | 2006 | — |
| +2 | K182559 | PREMIER Platinum HpSA PLUS | Meridian Bioscience, Inc. | 2018 | — |
| +1 | K032222 | Immunocardstat Hpsa | Meridian Bioscience, Inc. | 2003 | — |
| +3 | K232892 | Hp Detect™ Stool Antigen ELISA | Biomerica, Inc. | 2023 | — |
| +3 | K230901 | Premier HpSA Flex (619096) | Meridian Bioscience, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Meretek UBT Named without a submission number |
What descends from it? (10)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 26, 2002 | Not classified | Z-0465-03 | Other | Due to defective packaging, the firm cannot assure product stability through the labeled expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053335 (Meridian Bioscience, Inc., 2006) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LYR devicesLYR Helicobacter Pylori: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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 adult 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983255: Modification to: Premier Platinum Hpsa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983255
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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