510(k) · Cleared
ClearedBioplex 2200 MMRV Igg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · OPL Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
Cleared on Mar 29, 2010 as substantially equivalent to K961053 (Quest Intl., Inc., 1996) and 1 other predicate after a 299-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.
- Decided
- Mar 29, 2010
- Review
- 299 days
- Class
- Class II
- Product code
- OPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K923122 (1992). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK923122 Vitek Immunodiagnostic Assay SystemBiomerieux Vitek, Inc. · 1992 · Recalled
- This deviceK091616 Bioplex 2200 MMRV IggBio-Rad Laboratories · 2010
- Descendant · cites it directly · 0 of its ownK212769 DYNEX SmartPLEX MMRV IgG Assay KitDynex Technologies, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK111072 Bioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection…Bio-Rad Laboratories · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923122 | Vitek Immunodiagnostic Assay System | Biomerieux Vitek, Inc. | 1992 | 2 |
| 0 (this device) | K091616 | Bioplex 2200 MMRV Igg | Bio-Rad Laboratories | 2010 | — |
| +1 | K212769 | DYNEX SmartPLEX MMRV IgG Assay Kit | Dynex Technologies, Inc. | 2023 | — |
| +1 | K111072 | Bioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection System… | Bio-Rad Laboratories | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2023 | 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 OPL? 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 OPL device
- #1 K212769 DYNEX SmartPLEX MMRV IgG Assay Kitscore 6.4 · 2 generations · no Class I recall
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K961053 | Seraquest Rubella Igg | 1996 |
| * | K923122 | Vitek Immunodiagnostic Assay SystemSummary page 2…N/A Bio-Rad Rubella lgG EIA K(961 053 9/14/1996 BioMerieux VIDAS Varicella-Zoster IgG Q/ZV) k923122 10/26/1 992 DEVICE DESCRIPTION The BioPlex 2200 MMRV IgG kit uses multiplex flow immunoassay, a methodology that… | 1992 |
| * | — | BioMerieux VIDAS Measles IgG (MSG) Named without a submission number | |
| * | — | BioMerieux VIDAS Mumps IgG (MPG) Named without a submission number |
What descends from it? (2)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K212769 (Dynex Technologies, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OPL devicesOPL Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OPL
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OPL
Too few OPL 510(k)s in any year since 2007 to give a median.
Recalls per year · OPL
No recall names OPL since 2007.
Adverse event reports per year · OPL
No MAUDE report names OPL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BioPlex 2200 MMRV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of IgG antibodies to Measles, Mumps, Rubella, and Varicella-zoster virus (VZV) in human serum and EDTA or heparinized plasma. The BioPlex 2200 MMRV IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
This kit is intended as an aid in the determination of serological status to Measles, Mumps, Rubella, and VZV. This kit is not intended for use in screening blood or plasma donors.
The performance of this assay has not been established for use in neonates, pediatrics and immunocompromised patients, or for use at point of care facilities.
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/K091616 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091616: Bioplex 2200 MMRV Igg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091616
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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