510(k) · Cleared
ClearedBioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Cleared on Dec 3, 2010 as substantially equivalent to K010668 (Bayer Corp., 2001) and 1 other predicate after a 466-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Dec 3, 2010
- Review
- 466 days
- Class
- Class II
- Product code
- LFX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K933549 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK933549 Vidas CMV Igm AssayBiomerieux Vitek, Inc. · 1994 · Recalled
- This deviceK092587 Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte…Bio-Rad Laboratories · 2010
- Descendant · cites it directly · 0 of its ownK170509 BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex…Bio-Rad Laboratories · 2017
Most influential descendants
Showing 1 of 1 · See all- K170509BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM…Bio-Rad Laboratories · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933549 | Vidas CMV Igm Assay | Biomerieux Vitek, Inc. | 1994 | 2 |
| 0 (this device) | K092587 | Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection… | Bio-Rad Laboratories | 2010 | — |
| +1 | K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC… | Bio-Rad Laboratories | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K010668 | Bayer Diagnostics Advia Centaur Rubella Igm AssaySummary page 5…2200 ADVIA Centaur bioMerldux, Inc. VIDAS® ___________ Rubella and CMV 1gM Kit Rubella 1gM (K010668) CMV 1gM (K933549) Intended Use he BioPle T 2200 Rubella and The ADVIA Centaur and… | 2001 |
| * | K933549 | Vidas CMV Igm AssaySummary page 1…ds (assayed and unassayed) 3. PREDICATE DEVICES * ADVIA Centaur® Rubella IgM KO010668 " bioMeri~ux VIDAS® CMV 1gM K933549 4. DEVICE DESCRIPTION The BioPlex® 2200 Rubella and CMVV IgM kit uses multiplex flow immunoassay, a methodology that great… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM… | 2017 | 0 |
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?
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. 2010, 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 BioPlex@- 2200 Rubella and CMV IgM kit is a multiplex flow inmmoassay intended for the qualitative detection of 1gM antibodies to Rubella and Cytomnegalovirus (CMV) in human serum and potassium EDTA or sodium heparin plasma. The BioPlex 2200 Rubella and CMIV 1gM kit is intended for use with the Bio-Rad BioPlex 2200 System. This kit is intended as an aid in the diagnosis of a curr ent or recent Rubella and/or CMV infection, in individuals suspected of…
Read the full statement (239 words)
The BioPlex@- 2200 Rubella and CMV IgM kit is a multiplex flow inmmoassay intended for the qualitative detection of 1gM antibodies to Rubella and Cytomnegalovirus (CMV) in human serum and potassium EDTA or sodium heparin plasma.
The BioPlex 2200 Rubella and CMIV 1gM kit is intended for use with the Bio-Rad BioPlex 2200 System.
This kit is intended as an aid in the diagnosis of a curr ent or recent Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states including women of child bearing age.
This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors.
Performance characteristics for the Rubella and CMV 1gM assays have not been evaluated in immunosupressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at point of care facilities.
The BioPlex® 2200 Rubella and CMV 1gM Calibrator Set is intended for the calibration of the Biollex - 2200 Rubella and CMV 1gM Reagent Pack.
The Biollex® 2200 Rubella and CMV 1gM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and BioPlex 2200 Rubella and CMV 1gM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Rubella and CMV 1gM Control Set has not been established with any other Rubella and CMV 1gM assays.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K092587 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092587: Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092587
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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