OPMClass II

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

21 CFR 866.3510 / Microbiology

OPM is the FDA product code for Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2, a class II device type, regulated under 21 CFR 866.3510. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2010-07-16, and no recalls.

Classification record

Product code: OPM
Device name: Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
FDA definition: 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 intended for use in screening blood or plasma donors.
Regulation: 21 CFR 866.3510
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code OPM

By decision year

1 clearance under product code OPM with a decision year between 2010 and 2010, 2010 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OPM by decision year
Year	Clearances
2010	1

Applicants with the most clearances

Product code OPM

Applicants holding the most 510(k) clearances under product code OPM
Applicant	Clearances
Zeus Scientific LLC	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code OPM

K093784Class IIAthena Multi-Lyte Torch Igg Plus Test SystemZeus Scientific, Inc. / cleared 2010-07-16

Recent recalls

Product code OPM

FDA records show no recalls under product code OPM.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)