510(k) Report

FDA product code · Microbiology

Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

OPLClass II21 CFR 866.3510510(k) required3 decisions since 20100 recalls

3 FDA decisions since 2010. 510(k) reviews decided 2021–2025 took a median of 759 days (half between 759 and 759). No recall names this code. The most-cited predicate is K091616, named by 2 later devices.

The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to measles virus, mumps virus, Rubella and varicella zoster virus (VZV) in human serum and/ or plasma. The results of this assay are intended to be used as an aid in the assessment of a patient¿s serological status to measles virus, mumps virus, Rubella and VZV. The test is not intended for use in screening…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, microbiology panel

Twenty years of OPL at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OPL

1in 2023

2010: 12011: 12023: 1
2007high 1 (2010) · low 0 (2007)2026

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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20111—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20231—00
20240—00
20250—00
20260—0—
FIG. 1 — OPL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OPL? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do OPL devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K091616Bioplex 2200 MMRV IggBio-Rad Laboratories · 20102cite it

Which OPL devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K212769DYNEX SmartPLEX MMRV IgG Assay KitDynex Technologies, Inc. · 20232generations
  • K111072Bioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200 MMRV Igg Calibrator…Bio-Rad Laboratories · 20112generations
  • K091616Bioplex 2200 MMRV IggBio-Rad Laboratories · 20101generation

What has FDA decided in OPL lately?

  • K212769DYNEX SmartPLEX MMRV IgG Assay KitDynex Technologies, Inc. · 2023
  • K111072Bioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200 MMRV Igg Calibrator…Bio-Rad Laboratories · 2011
  • K091616Bioplex 2200 MMRV IggBio-Rad Laboratories · 2010

All 3 OPL decisions →

Related product codes

Other codes under 21 CFR 866.3510.

OMI Multiplex Flow Immunoassay, T. Gondii, Rubella…LSD Rubella, Other AssaysPUQ Multiplex Flow Immunoassay, T. Gondii…GOJ Antisera, Neutralization, RubellaOPM Multiplex Immunoassay For T. Gondii, Rubella…GON Antigen, Cf (Including Cf Control), RubellaGOK Antisera, Hai (Including Hai Control), RubellaLFX Enzyme Linked Immunoabsorbent Assay, RubellaGOM Antisera, Cf, RubellaLQN Latex Agglutination Assay, RubellaGOL Antigen, Ha (Including Ha Control), RubellaLSJ Antigen, Rubella, Other