DeviceClearance

Product code OPM— Microbiology

ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM

Classification name
Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
Device class
Class 2
Regulation
21 CFR 866.3510
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OPM under 21 CFR 866.3510, via openFDA

Market context for product code OPM

FDA has cleared 1 device under product code OPM, all in 2010, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OPM

Recent clearances under product code OPM

Data sourced from openFDA. This site is unofficial and independent of the FDA.