510(k) · Cleared
Recalled · 2000The Aptus (Automated) Application of the Rubella Igm Elisa Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeus Scientific, Inc. · LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Cleared on Jul 20, 1999 after a 239-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it. It has been recalled once.
- Decided
- Jul 20, 1999
- Review
- 239 days
- Class
- Class II
- Product code
- LFX
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK984180 The Aptus (Automated) Application of the Rubella Igm Elisa Test SystemZeus Scientific, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK092322 Elecsys Rubella Igm ImmunoassayRoche Diagnostics · 2010
- Descendant · cites it directly · 2 of its ownK072617 Elecsys Rubella Igg ImmunoassayRoche Diagnostics Corp. · 2008
- Descendant · 2 generations on · 1 of its ownK142133 Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmRoche Diagnostics · 2014
- Descendant · 2 generations on · 1 of its ownK131605 Elecsys Precicontrol CMV Igg, Elecsys CMV Igg ImmunoassayRoche Diagnostics · 2014
- Descendant · 3 generations on · 0 of its ownK220911 Elecsys CMV IgGRoche Diagnostics · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K092322Elecsys Rubella Igm ImmunoassayRoche Diagnostics · 2010 · cites it directly2descendants
- K072617Elecsys Rubella Igg ImmunoassayRoche Diagnostics Corp. · 2008 · cites it directly2descendants
- K142133Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmRoche Diagnostics · 2014 · 2 generations on1descendant
- K131605Elecsys Precicontrol CMV Igg, Elecsys CMV Igg ImmunoassayRoche Diagnostics · 2014 · 2 generations on1descendant
- K220911Elecsys CMV IgGRoche Diagnostics · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984180 | The Aptus (Automated) Application of the Rubella Igm Elisa Test System | Zeus Scientific, Inc. | 1999 | — |
| +1 | K092322 | Elecsys Rubella Igm Immunoassay | Roche Diagnostics | 2010 | — |
| +1 | K072617 | Elecsys Rubella Igg Immunoassay | Roche Diagnostics Corp. | 2008 | — |
| +2 | K142133 | Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV Igm | Roche Diagnostics | 2014 | — |
| +2 | K131605 | Elecsys Precicontrol CMV Igg, Elecsys CMV Igg Immunoassay | Roche Diagnostics | 2014 | — |
| +3 | K220911 | Elecsys CMV IgG | Roche Diagnostics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 24, 2000 | Not classified | Z-1065-03 | Other | The high positive control/low positive standard ratio recovering too low. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092322 (Roche Diagnostics, 2010) has gone furthest, with 2 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 | — |
What is it indicated for?
The Rubella IgM ELISA test system is and enzyme-linked immunosorbent assay (ELISA) designed for the manual or automated (Aptus), qualitative determination of IgM-class antibody to rubelia virus in human serum. The test is intended to be used to evaluate serologic evidence of primary or active infection with Rubella and is for in vitro diagnostic use.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984180 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984180: The Aptus (Automated) Application of the Rubella Igm Elisa Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984180
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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