510(k) · Cleared
ClearedBioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200 MMRV Igg Calibrator Set, and Biopl
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 Aug 23, 2011 as substantially equivalent to K091616 (Bio-Rad Laboratories, 2010) after a 127-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Aug 23, 2011
- Review
- 127 days
- Class
- Class II
- Product code
- OPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923122 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923122 | Vitek Immunodiagnostic Assay System | Biomerieux Vitek, Inc. | 1992 | 2 |
| −1 | K091616 | Bioplex 2200 MMRV Igg | Bio-Rad Laboratories | 2010 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K091616 | Bioplex 2200 MMRV IggSummary page 1…Microbiology Registration Number 886.3510 Product Code OPL Legally Marketed Predicate Device BioPlex 2200 MMRV lgG, k091616 Intended Use/Indications For Use The BioPlexl 2200 MMRV lgG kit is a multiplex flow immunoassay intended for the qualitative det… | 2010 |
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?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 17.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K091616.
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. 2011, 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…
Read the full statement (189 words)
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 neonatal, pediatrics and immunocompromised patients, or for use at point of care facilities.
The BioPlex® 2200 MMRV IgG Calibrator Set is intended for the calibration of the BioPlex® 2200 MMRV IgG Reagent Pack.
The BioPlex® 2200 MMRV IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and BioPlex 2200 MMRV IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 MMRV IgG Control Set has not been established with any other Measles, Mumps, Rubella or VZV IgG assays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111072: Bioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200 MMRV Igg Calibrator Set, and Biopl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111072
Report an extraction error
Are you the manufacturer?
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