510(k) · Cleared
ClearedUni-Gold H. Pylori
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trinity Biotech, Plc · LYR Helicobacter Pylori
Cleared on Dec 21, 1999 after a 217-day review. The FDA summary names its predicate without a number.
- Decided
- Dec 21, 1999
- Review
- 217 days
- Class
- Class I
- Product code
- LYR
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Quidel QuickVue One-Step H. pylori Test Named without a submission number |
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.
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 Trinity Biotech Uni-Gold™ H. pylori assay is intended for the rapid in-vitro qualitative detection of IgG antibodies to Helicobacter pylori (H. pylori) in adult human serum, plasma, or whole blood as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease.
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/K991697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991697: Uni-Gold H. Pylori.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991697
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026