FDA product code OPM: Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
OPM is the FDA product code for multiplex immunoassay for t. gondii, rubella, cytomegalovirus and herpes simplex virus 1 and 2. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under OPM. The average 510(k) review took 219 days (median 219).
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.
Classification
| Field | Value |
|---|---|
| Device name | Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2 |
| Device class | Class II |
| Regulation | 21 CFR 866.3510 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OPM clearance
Top OPM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zeus Scientific, Inc. | 1 | 2010-07-16 |
Most recent OPM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093784 | Zeus Scientific, Inc. | ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM | 2010-07-16 | 219 |
Recalls for OPM devices
openFDA lists no recalls for product code OPM.
Frequently asked questions
What is FDA product code OPM?
OPM is the FDA product code for multiplex immunoassay for t. gondii, rubella, cytomegalovirus and herpes simplex virus 1 and 2. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel.
What device class is OPM?
Class II, regulation 21 CFR 866.3510. Typical premarket route: 510(k).
How long does a 510(k) take for product code OPM?
Across 1 cleared submissions the average was 219 days from receipt to decision (median 219).
Which companies have the most OPM clearances?
Zeus Scientific, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OPM
- Run a recall and safety report across every OPM manufacturer
- Watch product code OPM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times