510(k) · Cleared
ClearedElecsys Rubella Igm Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Cleared on Mar 12, 2010 as substantially equivalent to K984180 (Zeus Scientific, Inc., 1999) and 1 other predicate after a 220-day review. Its family tree reaches back 5 generations to 1993. 2 later devices descend from it.
- Decided
- Mar 12, 2010
- Review
- 220 days
- Class
- Class II
- Product code
- LFX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K931172 (1993). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 4 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 3 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 2 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 1 generation backK031990 Elecsys Precicontrol Troponin TRoche Diagnostics Corp. · 2003
- This deviceK092322 Elecsys Rubella Igm ImmunoassayRoche Diagnostics · 2010
- Descendant · cites it directly · 1 of its ownK142133 Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmRoche Diagnostics · 2014
- Descendant · 2 generations on · 0 of its ownK163569 Elecsys CMV IgMRoche Diagnostics · 2017 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −4 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −3 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −2 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −1 | K031990 | Elecsys Precicontrol Troponin T | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | K092322 | Elecsys Rubella Igm Immunoassay | Roche Diagnostics | 2010 | — |
| +1 | K142133 | Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV Igm | Roche Diagnostics | 2014 | — |
| +2 | K163569 | Elecsys CMV IgM | Roche Diagnostics | 2017 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K984180 | The Aptus (Automated) Application of the Rubella Igm Elisa Test SystemSummary page 3…____ ____ ____ ____ __ ___ ____ ____ ___(K 984180) Intended Use The Elecsys Rubella 1gM The Zeus Scientific. Inc. Laboratories… | 1999 |
| * | K031990 | Elecsys Precicontrol Troponin TSummary page 2…lla 1gM ELISA Test System cleared in K984l180 (2) Elecsvs PreciControl Rubella IgM is equivalent to the Elecsys PreciControl TnT (K03 1990) The devices are compared to their predicates in the tables below. Elecsys Rubella 1gM Test… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142133 | Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV Igm | 2014 | 1 |
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 4 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K142133 (Roche Diagnostics, 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K984180.
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. 2010, 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 Elecsys Rubella IgM immunoassay is for the in vitro qualitative determination of IgM antibodies to rubella virus in human serum and Li-heparin, K3-EDTA, and sodium citrate plasma. This assay may be used as an aid in the presumptive diagnosis of an acute or recent rubella infection in individuals, including women of childbearing age. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers. NOTE: This assay has not been cleared/approved by the FDA for blood/plasma donor screening.
Elecsys PreciControl Rubella IgM is used for quality control of the Elecsys Rubella IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092322 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092322: Elecsys Rubella Igm Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092322
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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