FDA product code OMG: Antisera, Fluorescent, Human Metapneumovirus
OMG is the FDA product code for antisera, fluorescent, human metapneumovirus. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under OMG, from 2 different applicants. The average 510(k) review took 84 days (median 70).
Definition
It is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in direct respiratory specimens or cell culture. The assay detects hMPV antigens by immunofluorescence using antibodies, from patients with signs and symptoms of acute respiratory infection. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, Human Metapneumovirus |
| Device class | Class II |
| Regulation | 21 CFR 866.3980 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OMG clearance
Top OMG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Hybrids, Inc. | 3 | 2009-12-04 |
| Millipore Corporation | 1 | 2010-03-12 |
Most recent OMG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093815 | Millipore Corporation | LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 | 2010-03-12 | 88 |
| K093233 | Diagnostic Hybrids, Inc. | D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT | 2009-12-04 | 51 |
| K091171 | Diagnostic Hybrids, Inc. | D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT | 2009-09-11 | 142 |
| K090073 | Diagnostic Hybrids, Inc. | D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT | 2009-03-06 | 53 |
Recalls for OMG devices
openFDA lists no recalls for product code OMG.
Frequently asked questions
What is FDA product code OMG?
OMG is the FDA product code for antisera, fluorescent, human metapneumovirus. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel.
What device class is OMG?
Class II, regulation 21 CFR 866.3980. Typical premarket route: 510(k).
How long does a 510(k) take for product code OMG?
Across 4 cleared submissions the average was 84 days from receipt to decision (median 70).
Which companies have the most OMG clearances?
Diagnostic Hybrids, Inc. (3); Millipore Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OMG
- Run a recall and safety report across every OMG manufacturer
- Watch product code OMG 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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