510(k) · Cleared
ClearedBayer Diagnostics Advia Centaur Rubella Igm Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Cleared on Jul 5, 2001 after a 121-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jul 5, 2001
- Review
- 121 days
- Class
- Class II
- Product code
- LFX
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK010668 Bayer Diagnostics Advia Centaur Rubella Igm AssayBayer Corp. · 2001
- Descendant · cites it directly · 3 of its ownK122397 Liaison Rubella Igm, Liaison Control Rubella IgmDiaSorin, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK132234 Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg IIDiaSorin, Inc. · 2013
- Descendant · 3 generations on · 1 of its ownK161139 LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetDiaSorin, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK092587 Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte…Bio-Rad Laboratories · 2010
- Descendant · 4 generations on · 0 of its ownK181464 LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K122397Liaison Rubella Igm, Liaison Control Rubella IgmDiaSorin, Inc. · 2012 · cites it directly3descendants
- K132234Liaison (R) Toxo Igg II, Liaison (R) Control Toxo Igg IIDiaSorin, Inc. · 2013 · 2 generations on2descendants
- K161139LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetDiaSorin, Inc. · 2016 · 3 generations on1descendant
- K092587Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection SystemBio-Rad Laboratories · 2010 · cites it directly1descendant
- K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc. · 2018 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010668 | Bayer Diagnostics Advia Centaur Rubella Igm Assay | Bayer Corp. | 2001 | — |
| +1 | 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 | — |
| +3 | K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set | DiaSorin, Inc. | 2016 | — |
| +1 | K092587 | Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection… | Bio-Rad Laboratories | 2010 | — |
| +4 | K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set | DiaSorin, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
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?
- Of its descendants, K122397 (DiaSorin, Inc., 2012) has gone furthest, with 3 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K010668 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010668: Bayer Diagnostics Advia Centaur Rubella Igm Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010668
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026