510(k) · Cleared
ClearedHp Detect™ Stool Antigen ELISA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerica, Inc. · LYR Helicobacter Pylori
Cleared on Dec 15, 2023 as substantially equivalent to K182559 (Meridian Bioscience, Inc., 2018) after an 88-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Dec 15, 2023
- Review
- 88 days
- Class
- Class I
- Product code
- LYR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K980076 (1998). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK980076 Premier Platinum HpsaMeridian Diagnostics, Inc. · 1998
- 2 generations backK053335 Premier Platinum Hpsa Plus, Models 601396, 601480Meridian Bioscience, Inc. · 2006
- 1 generation backK182559 PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc. · 2018
- This deviceK232892 Hp Detect™ Stool Antigen ELISABiomerica, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980076 | Premier Platinum Hpsa | Meridian Diagnostics, Inc. | 1998 | — |
| −2 | K053335 | Premier Platinum Hpsa Plus, Models 601396, 601480 | Meridian Bioscience, Inc. | 2006 | — |
| −1 | K182559 | PREMIER Platinum HpSA PLUS | Meridian Bioscience, Inc. | 2018 | — |
| 0 (this device) | K232892 | Hp Detect™ Stool Antigen ELISA | Biomerica, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 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 K230901 Premier HpSA Flex (619096)score 6.2 · 3 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K182559 | PREMIER Platinum HpSA PLUSSummary page 4…Class I Product Code: LYR Panel: 83-Microbiology D. PREDICATE DEVICE PREMIER Platinum HpSA PLUS (K182559) E. DEVICE DESCRIPTION The Hp Detect Stool Antigen ELISA is an enzyme immunoassay which detects the H. pylori antigen i… | 2018 |
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 25 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K182559.
How does its category compare?
All LYR devicesLYR Helicobacter Pylori: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Hp Detect™ Stool Antigen ELISA is an in vitro diagnostic qualitative enzyme immunoassay for the detection of
Helicobacter pylori (H. pylori) antigens in human stool or feces. The Hp Detect™ Stool Antigen ELISA is intended to aid
in the initial diagnosis and post-therapy diagnosis of H. pylori infection. Additionally, the test may be used to assess H.
pylori infection status after treatment. Retesting at a minimum of 4 weeks after the completion of treatment may be done
to assess H. pylori status. Test results should always be taken into consideration by the physician in conjunction with
patient’s clinical information (history and symptoms).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232892 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232892: Hp Detect™ Stool Antigen ELISA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232892
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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