510(k) · Cleared
ClearedVitros Immunodiagnostic Products Rubella Igg Reagant Pack and Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Cleared on Dec 26, 2006 as substantially equivalent to K954045 (Abbott Laboratories, 1996) after a 71-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Dec 26, 2006
- Review
- 71 days
- Class
- Class II
- Product code
- LFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954045 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK954045 Axsym Rubella Igg Antibody AssayAbbott Laboratories · 1996 · Recalled
- This deviceK063143 Vitros Immunodiagnostic Products Rubella Igg Reagant Pack and…Ortho-Clinical Diagnostics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954045 | Axsym Rubella Igg Antibody Assay | Abbott Laboratories | 1996 | 2 |
| 0 (this device) | K063143 | Vitros Immunodiagnostic Products Rubella Igg Reagant Pack and Calibrators | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
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? (1)
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 |
|---|---|---|---|
| * | K954045 | Axsym Rubella Igg Antibody AssaySummary page 1…ethod Regulation 866.3510 Class: 2 Product Code: LFX 1.5 Predicate Device ABBOTT AxSYM Rubella IgG Assay: K954045. 1.6 Device Description The VITROS Rubella IgG assay is performed using the VITROS Immunodiagnostic… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K954045.
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?
For in vitro diagnostic use only.
The VITROS Immunodiagnostic Products Rubella IgG assay is intended for the quantitative determination of IgG antibodies to rubella virus in human serum and plasma (heparin, EDTA or sodium citrate) using the VITROS Immunodiagnostic System.
The VITROS Rubella IgG assay is for use in the clinical laboratory to aid in the determination of immunity to rubella virus infection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063143 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063143: Vitros Immunodiagnostic Products Rubella Igg Reagant Pack and Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063143
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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