FDA product code OEM: Human Metapneumovirus (Hmpv) Rna Assay System
OEM is the FDA product code for human metapneumovirus (hmpv) rna assay system. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel. FDA has cleared 6 510(k) submissions under OEM, 1 in the last five years, from 4 different applicants. The average 510(k) review took 80 days (median 44).
Definition
A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infections.
Classification
| Field | Value |
|---|---|
| Device name | Human Metapneumovirus (Hmpv) Rna Assay System |
| Device class | Class II |
| Regulation | 21 CFR 866.3980 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for OEM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 29 |
Compare with all 510(k) review times · Search every OEM clearance
Top OEM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gen-Probe Prodesse, Inc. | 2 | 2013-08-14 |
| Quidel Corp. | 2 | 2013-03-08 |
| Quidel Corporation | 1 | 2023-03-10 |
| Prodesse, Inc. | 1 | 2008-11-07 |
Most recent OEM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230349 | Quidel Corporation | Lyra RSV+hMPV Assay | 2023-03-10 | 29 |
| K132200 | Gen-Probe Prodesse, Inc. | PRO HMPV+ ASSAY | 2013-08-14 | 29 |
| K122189 | Quidel Corp. | QUIDEL MOLECULAR RSV + HMPV ASSAY | 2013-03-08 | 227 |
| K123838 | Gen-Probe Prodesse, Inc. | PRO HMPV+ ASSAY | 2013-01-16 | 34 |
| K112490 | Quidel Corp. | QUIDEL MOLECULAR HMPV ASSAY | 2011-12-15 | 108 |
Recalls for OEM devices
openFDA lists no recalls for product code OEM.
Frequently asked questions
What is FDA product code OEM?
OEM is the FDA product code for human metapneumovirus (hmpv) rna assay system. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel.
What device class is OEM?
Class II, regulation 21 CFR 866.3980. Typical premarket route: 510(k).
How long does a 510(k) take for product code OEM?
Across 6 cleared submissions the average was 80 days from receipt to decision (median 44).
Which companies have the most OEM clearances?
Gen-Probe Prodesse, Inc. (2); Quidel Corp. (2); Quidel Corporation (1); Prodesse, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OEM
- Run a recall and safety report across every OEM manufacturer
- Watch product code OEM 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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