FDA product code OMI: Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
OMI is the FDA product code for multiplex flow immunoassay, t. gondii, rubella and cmv. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under OMI. The average 510(k) review took 223 days (median 223). FDA has posted 1 recall for OMI devices.
Definition
The kit is a multiplex immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella, and qualitative detection of Cytomegalovirus (CMV) IgG in human serum and/ or plasma. Indicated as an aid in the determination of serological status to T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors.
Classification
| Field | Value |
|---|---|
| Device name | Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv |
| 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 OMI clearance
Top OMI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad Laboratories, Inc. | 2 | 2012-03-26 |
Most recent OMI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K120572 | Bio-Rad Laboratories, Inc. | BIOPLEX 2200 TORC IGG | 2012-03-26 | 28 |
| K080008 | Bio-Rad Laboratories, Inc. | BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET | 2009-02-23 | 418 |
Recalls for OMI devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-12-22.
Frequently asked questions
What is FDA product code OMI?
OMI is the FDA product code for multiplex flow immunoassay, t. gondii, rubella and cmv. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel.
What device class is OMI?
Class II, regulation 21 CFR 866.3510. Typical premarket route: 510(k).
How long does a 510(k) take for product code OMI?
Across 2 cleared submissions the average was 223 days from receipt to decision (median 223).
Which companies have the most OMI clearances?
Bio-Rad Laboratories, Inc. (2).
Have OMI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-12-22.
Next steps
- Run an FDA pathway report with predicate devices for product code OMI
- Run a recall and safety report across every OMI manufacturer
- Watch product code OMI 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.
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