510(k) · Cleared
Recalled · 2008Axsym Rubella Igg Antibody Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Cleared on Sep 24, 1996 after a 392-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 24, 1996
- Review
- 392 days
- Class
- Class II
- Product code
- LFX
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK954045 Axsym Rubella Igg Antibody AssayAbbott Laboratories · 1996
- Descendant · cites it directly · 2 of its ownK080766 Vidas Rub IggbioMerieux, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK243168 Alinity i Rubella IgGAbbott Laboratories · 2025
- Descendant · 2 generations on · 0 of its ownK141133 VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG…Biomerieux · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK063143 Vitros Immunodiagnostic Products Rubella Igg Reagant Pack and…Ortho-Clinical Diagnostics, Inc. · 2006
Most influential descendants
Showing 4 of 4 · See all- K080766Vidas Rub IggbioMerieux, Inc. · 2008 · cites it directly2descendants
- K243168Alinity i Rubella IgGAbbott Laboratories · 2025 · 2 generations on0descendants
- K141133VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS…Biomerieux · 2015 · 2 generations on0descendants
- K063143Vitros Immunodiagnostic Products Rubella Igg Reagant Pack and CalibratorsOrtho-Clinical Diagnostics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954045 | Axsym Rubella Igg Antibody Assay | Abbott Laboratories | 1996 | — |
| +1 | K080766 | Vidas Rub Igg | bioMerieux, Inc. | 2008 | — |
| +2 | K243168 | Alinity i Rubella IgG | Abbott Laboratories | 2025 | — |
| +2 | K141133 | VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M… | Biomerieux | 2015 | 4 |
| +1 | K063143 | Vitros Immunodiagnostic Products Rubella Igg Reagant Pack and Calibrators | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|---|
| Jun 2, 2008 | Not classified | Z-2175-2008 | Device Design | An increase in complaints was noted for AxSYM Rubella IgG assay calibration failures due to error codes related to elevated Calibrator A (or Master Calibrator 1) rates too high. |
| Apr 23, 2007 | Not classified | Z-1025-2007 | Other | Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K080766 (bioMerieux, Inc., 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 | — |
https://510kreport.com/device/K954045 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954045: Axsym Rubella Igg Antibody Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954045
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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