510(k) · Cleared
ClearedThe Aptus (Automated) Application of the Rubella Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) FO
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 May 26, 1999 after a 210-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- May 26, 1999
- Review
- 210 days
- Class
- Class II
- Product code
- LFX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK983805 The Aptus (Automated) Application of the Rubella Igg Elisa Test…Zeus Scientific, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK072617 Elecsys Rubella Igg ImmunoassayRoche Diagnostics Corp. · 2008
- 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
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983805 | The Aptus (Automated) Application of the Rubella Igg Elisa Test System. an… | Zeus Scientific, Inc. | 1999 | — |
| +1 | K072617 | Elecsys Rubella Igg Immunoassay | Roche Diagnostics Corp. | 2008 | — |
| +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 |
| 2014 | 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072617 | Elecsys Rubella Igg Immunoassay | 2008 | 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?
- Of its descendants, K072617 (Roche Diagnostics Corp., 2008) 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 IgG ELISA test system is an enzyme linked immunosorbent assay (ELISA) intended for the manual or automated (Aptus) qualitative detection of IgG antibodies to Rubella virus in human serum. The test system is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, 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/K983805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983805: The Aptus (Automated) Application of the Rubella Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) FO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983805
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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