510(k) · Cleared
ClearedLIAISON H. pylori IgG, LIAISON H. pylori IgG 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 Jul 22, 2016 as substantially equivalent to K000463 (Diagnostic Products Corp., 2000) and 1 other predicate after a 91-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Jul 22, 2016
- Review
- 91 days
- Class
- Class I
- Product code
- LYR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010668 (2001). 5 ancestors in all, the oldest K981498 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK010668 Bayer Diagnostics Advia Centaur Rubella Igm AssayBayer Corp. · 2001
- 2 generations backK122397 Liaison Rubella Igm, Liaison Control Rubella IgmDiaSorin, Inc. · 2012
- 1 generation backK132234 Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg IIDiaSorin, Inc. · 2013
- This deviceK161139 LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetDiaSorin, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK181464 LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010668 | Bayer Diagnostics Advia Centaur Rubella Igm Assay | Bayer Corp. | 2001 | — |
| −2 | K122397 | Liaison Rubella Igm, Liaison Control Rubella Igm | DiaSorin, Inc. | 2012 | — |
| −1 | K132234 | Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg II | DiaSorin, Inc. | 2013 | — |
| 0 (this device) | K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set | DiaSorin, Inc. | 2016 | — |
| +1 | 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 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K000463 | Immulite H. Pylori Igg and Immulite 2000 H. Pylori IggSummary page 4…otometer for clinical use PREDICATE DEVICES : IMMULITE® 2000 H. pylori IgG Reference K000463 (assay) DiaSorin LIAISON® Control Toxo IgG II… | 2000 |
| * | K132234 | Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg IISummary page 4…Reference K000463 (assay) DiaSorin LIAISON® Control Toxo IgG II (K132234) DEVICE DESCRIPTION: INTENDED USE: The LIAISON® H. pylori IgG assay uses chemiluminescent immunoassay (CLIA) technology for the… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set | 2018 | 0 |
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 15 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K181464 (DiaSorin, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K000463.
How does its category compare?
All LYR devicesLYR Helicobacter Pylori: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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® H. pylori IgG assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of IgG antibodies to Helicobacter pylori in human serum from symptomatic adults as an aid in the diagnosis of Helicobacter pylori infection. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions. The test has to be performed on the LIAISON® XL Analyzer.
The LIAISON® H. pylori IgG Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® H. pylori IgG assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161139: LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161139
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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