510(k) · Cleared
ClearedImmunocardstat Hpsa
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 Dec 5, 2003 as substantially equivalent to K983255 (Meridian Diagnostics, Inc., 1998) after a 137-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Dec 5, 2003
- Review
- 137 days
- Class
- Class I
- Product code
- LYR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983255 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK983255 Modification to: Premier Platinum HpsaMeridian Diagnostics, Inc. · 1998 · Recalled
- This deviceK032222 Immunocardstat HpsaMeridian Bioscience, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK183573 Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK181379 H. Pylori Quik ChekTechlab, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983255 | Modification to: Premier Platinum Hpsa | Meridian Diagnostics, Inc. | 1998 | 1 |
| 0 (this device) | K032222 | Immunocardstat Hpsa | Meridian Bioscience, Inc. | 2003 | — |
| +1 | K183573 | Vstrip H. pylori Antigen Rapid Test | Panion & BF Biotech, Inc. | 2019 | — |
| +1 | K181379 | H. Pylori Quik Chek | Techlab, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 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 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 |
|---|---|---|---|
| * | K983255 | Modification to: Premier Platinum HpsaSummary page 1…ay for H. pylon stool antigen CLASSIFICATION NAME: Campylobacterpylon[83LYR] REGULATION: 866.3110 PREDICATE EQUIVALENT DEVICES: Premier Platinum HpSA® (K983255) INTENDED USE: ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacterpylon antigen (HpSA… | 1998 |
What descends from it? (2)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen (HpSA) in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylon infection and to demonstrate loss of H. pylon stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm the loss of antigen be done at least four weeks following completion of therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032222 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032222: Immunocardstat Hpsa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032222
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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