510(k) · Cleared
ClearedLIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · LYR Helicobacter Pylori
Cleared on Aug 31, 2018 as substantially equivalent to K053335 (Meridian Bioscience, Inc., 2006) and 1 other predicate after an 88-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Aug 31, 2018
- Review
- 88 days
- Class
- Class I
- Product code
- LYR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K010668 (2001). 9 ancestors in all, the oldest K980076 (1998). No later device cites it as a predicate yet.
- Root · 4 generations backK010668 Bayer Diagnostics Advia Centaur Rubella Igm AssayBayer Corp. · 2001
- 3 generations backK122397 Liaison Rubella Igm, Liaison Control Rubella IgmDiaSorin, Inc. · 2012
- 2 generations backK132234 Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg IIDiaSorin, Inc. · 2013
- 1 generation backK161139 LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetDiaSorin, Inc. · 2016
- This deviceK181464 LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010668 | Bayer Diagnostics Advia Centaur Rubella Igm Assay | Bayer Corp. | 2001 | — |
| −3 | K122397 | Liaison Rubella Igm, Liaison Control Rubella Igm | DiaSorin, Inc. | 2012 | — |
| −2 | K132234 | Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg II | DiaSorin, Inc. | 2013 | — |
| −1 | K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set | DiaSorin, Inc. | 2016 | — |
| 0 (this device) | K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set | DiaSorin, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2006 | 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? (2)
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…For Clinical Use PREDICATE DEVICES : Meridian Platinum Premier HpSA PLUS Reference K053335 assay LIAISON® H. pylori IgG Control Set (K161139) DEVICE DESCRIPTION: INTENDE… | 2006 |
| * | K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetSummary page 4…HpSA PLUS Reference K053335 assay LIAISON® H. pylori IgG Control Set (K161139) DEVICE DESCRIPTION: INTENDED USE: The LIAISON® Helicobacter Antigen assay is a chemiluminescent immunoassay (CLIA) intended for… | 2016 |
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 17 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 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 LIAISON® Helicobacter Antigen assay is a chemiluminescent immunoassay (CLIA) intended for the qualitative determination of Helicobacter pylori (H. pylori) antigen in human stool. The test is an aid in the diagnosis of patients suspected of H. pylori infection and to measure post therapy response from patients who have discontinued therapy for at least 4 weeks. Assay results should be used in conjunction with other clinical and laboratory data to…
Read the full statement (140 words)
The LIAISON® Helicobacter Antigen assay is a chemiluminescent immunoassay (CLIA) intended for the qualitative determination of Helicobacter pylori (H. pylori) antigen in human stool. The test is an aid in the diagnosis of patients suspected of H. pylori infection and to measure post therapy response from patients who have discontinued therapy for at least 4 weeks. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions.
The test must be performed on the LIAISON® XL Analyzer.
The LIAISON® Helicobacter Antigen Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Helicobacter Antigen assay.
The performance characteristics of the LIAISON® Helicobacter Antigen Control Set have not been established for any other assay or instrument platforms different from the LIAISON® XL.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181464 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181464: LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181464
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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