510(k) Report

FDA product code · Microbiology

Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

OPMClass II21 CFR 866.3510510(k) required1 decision since 20100 recalls

1 FDA decision since 2010. No recall names this code.

The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV) and Herpes Simplex Virus 1 & 2 (HSV 1 and HSV 2) in human serum. The results of this assay are intended to be used as an aid in the assessment of a patient's serological status to Toxoplasma gondii, Rubella, CMV and HSV 1 & 2. The test is not…

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 OPM 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 · OPM

1in 2010

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

2026 to Oct 25, outlined.

Median 510(k) review, days · OPM

Too few OPM 510(k)s in any year since 2007 to give a median.

Recalls per year · OPM

No recall names OPM since 2007.

Adverse event reports per year · OPM

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2025

MAUDE reports naming product code OPM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OPM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OPM? 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 OPM devices have the deepest lineage?

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

  • K093784Athena Multi-Lyte Torch Igg Plus Test SystemZeus Scientific, Inc. · 20101generation

What has FDA decided in OPM lately?

  • K093784Athena Multi-Lyte Torch Igg Plus Test SystemZeus Scientific, Inc. · 2010

The one OPM decision →

Related product codes

Other codes under 21 CFR 866.3510.

OPL Multiplex Immunoassay For Measles Virus, Mumps…OMI Multiplex Flow Immunoassay, T. Gondii, Rubella…LSD Rubella, Other AssaysPUQ Multiplex Flow Immunoassay, T. Gondii…GOJ Antisera, Neutralization, RubellaGON 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