510(k) · Cleared
ClearedElecsys Rubella Igg Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Cleared on Dec 5, 2008 as substantially equivalent to K983805 (Zeus Scientific, Inc., 1999) and 1 other predicate after a 445-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it.
- Decided
- Dec 5, 2008
- Review
- 445 days
- Class
- Class II
- Product code
- LFX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K983805 (1999). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK983805 The Aptus (Automated) Application of the Rubella Igg Elisa Test…Zeus Scientific, Inc. · 1999
- This deviceK072617 Elecsys Rubella Igg ImmunoassayRoche Diagnostics Corp. · 2008
- Descendant · cites it directly · 1 of its ownK131605 Elecsys Precicontrol CMV Igg, Elecsys CMV Igg ImmunoassayRoche Diagnostics · 2014
- Descendant · 2 generations on · 0 of its ownK220911 Elecsys CMV IgGRoche Diagnostics · 2022
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 |
|---|---|---|---|---|---|
| −1 | K983805 | The Aptus (Automated) Application of the Rubella Igg Elisa Test System. an… | Zeus Scientific, Inc. | 1999 | — |
| 0 (this device) | K072617 | Elecsys Rubella Igg Immunoassay | Roche Diagnostics Corp. | 2008 | — |
| +1 | K131605 | Elecsys Precicontrol CMV Igg, Elecsys CMV Igg Immunoassay | Roche Diagnostics | 2014 | — |
| +2 | K220911 | Elecsys CMV IgG | Roche Diagnostics | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K983805 | The Aptus (Automated) Application of the Rubella Igg Elisa Test System. an Enzyme Linked…Summary page 2…ted States. equivalence Elecsys Rubella IgG Immunoassay is equivalent to the Zeus Scientific Rubella IgG ELISA Test System cleared in K983805 510(k) Summary, Continued Substantial equivalence - similarities (1) Rubella IgG Im… | 1999 |
| * | K984180 | The Aptus (Automated) Application of the Rubella Igm Elisa Test SystemSummary page 3…ce: Zeus Scientific Immunoassay Rubella IgG ELISA Test System (K984180) Intended Use The Elecsys Rubella IgG The Zeus Scientific, Inc. Laboratories immunoass… | 1999 |
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 |
|---|---|---|---|
| K131605 | Elecsys Precicontrol CMV Igg, Elecsys CMV Igg Immunoassay | 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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K131605 (Roche Diagnostics, 2014) has gone furthest, with 1 descendant 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. 2008, 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 IgG immunoassay is for the in vitro quantitative determination of IgG 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 assessment of immune status to rubella in individuals including women of childbearing age.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Elecsys PreciControl Rubella IgG is used for quality control of the Elecsys Rubella IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072617 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072617: Elecsys Rubella Igg Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072617
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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