510(k) · Cleared
ClearedLiaison Rubella Igm, Liaison Control Rubella Igm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Cleared on Sep 6, 2012 as substantially equivalent to K010668 (Bayer Corp., 2001) after a 30-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Sep 6, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- LFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010668 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK010668 Bayer Diagnostics Advia Centaur Rubella Igm AssayBayer Corp. · 2001
- This deviceK122397 Liaison Rubella Igm, Liaison Control Rubella IgmDiaSorin, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK132234 Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg IIDiaSorin, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK161139 LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetDiaSorin, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK181464 LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K132234Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg IIDiaSorin, Inc. · 2013 · cites it directly2descendants
- K161139LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetDiaSorin, Inc. · 2016 · 2 generations on1descendant
- K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010668 | Bayer Diagnostics Advia Centaur Rubella Igm Assay | Bayer Corp. | 2001 | — |
| 0 (this device) | 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 | — |
| +2 | K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set | DiaSorin, Inc. | 2016 | — |
| +3 | K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set | DiaSorin, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 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 LFX? 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 LFX device
- #1 K250588 Access Rubella IgGscore 10.4 · 1 generation · 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 |
|---|---|---|---|
| * | K010668 | Bayer Diagnostics Advia Centaur Rubella Igm AssaySummary page 2…nated plasma reactive for Rubella IgM J. Substantial Equivalence Information: 1. Predicate device name(s): ADVIA Centaur Rubella laM Assay 2. Predicate 510k number(s): K010668 3. Comparison with predicate: Table 1: Table of Similarities New Device… | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132234 | Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg II | 2013 | 2 |
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 LFX devicesLFX Enzyme Linked Immunoabsorbent Assay, Rubella: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LFX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFX
354in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFX
12in 2025
MAUDE reports naming product code LFX, 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 | 1 | — | 2 | 5 |
| 2008 | 3 | 354 | 2 | 367 |
| 2009 | 0 | — | 3 | 19 |
| 2010 | 2 | — | 2 | 18 |
| 2011 | 1 | — | 1 | 89 |
| 2012 | 1 | — | 0 | 37 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 0 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 0 | — | 2 | 47 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 0 | — | 0 | 16 |
| 2020 | 0 | — | 0 | 21 |
| 2021 | 0 | — | 1 | 13 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 13 |
| 2025 | 2 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LIAISON® Rubella IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to rubella virus in human serum samples. It is intended for use as an aid in the diagnosis of a current or recent Rubella infection in individuals with signs and symptoms of Rubella, or suspected of having rubella virus infection, including women of child bearing age. The LIAISON® Control Rubella…
Read the full statement (113 words)
The LIAISON® Rubella IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to rubella virus in human serum samples. It is intended for use as an aid in the diagnosis of a current or recent Rubella infection in individuals with signs and symptoms of Rubella, or suspected of having rubella virus infection, including women of child bearing age.
The LIAISON® Control Rubella IgM (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Rubella IgM assay. The performance characteristics of LIAISON® Rubella IgM controls have not been established for any other assays or instrument platforms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122397 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122397: Liaison Rubella Igm, Liaison Control Rubella Igm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122397
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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