FDA product code OOU: Parainfluenza Multiplex Nucleic Acid Assay
OOU is the FDA product code for parainfluenza multiplex nucleic acid assay. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel. FDA has cleared 5 510(k) submissions under OOU, from 4 different applicants. The average 510(k) review took 93 days (median 85).
Definition
A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human parainfluenza nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Parainfluenza Multiplex Nucleic Acid Assay |
| 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 OOU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 87 |
Compare with all 510(k) review times · Search every OOU clearance
Top OOU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hologic, Inc. | 2 | 2017-10-23 |
| Quidel Corporation | 1 | 2014-10-09 |
| Gen-Probe Prodesse, Inc. | 1 | 2013-08-26 |
| Prodesse, Inc. | 1 | 2009-11-20 |
Most recent OOU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172282 | Hologic, Inc. | Panther Fusion Paraflu Assay | 2017-10-23 | 87 |
| K153223 | Hologic, Inc. | ProParaFlu+ Assay | 2015-12-09 | 33 |
| K141927 | Quidel Corporation | LYRA PARAINFLUENZA VIRUS ASSAY | 2014-10-09 | 85 |
| K132238 | Gen-Probe Prodesse, Inc. | PROPARAFLU+ ASSAY | 2013-08-26 | 39 |
| K091053 | Prodesse, Inc. | PROPARAFLU+ASSAY | 2009-11-20 | 221 |
Recalls for OOU devices
openFDA lists no recalls for product code OOU.
Frequently asked questions
What is FDA product code OOU?
OOU is the FDA product code for parainfluenza multiplex nucleic acid assay. It is a Class II device, regulated under 21 CFR 866.3980 and reviewed by the Microbiology panel.
What device class is OOU?
Class II, regulation 21 CFR 866.3980. Typical premarket route: 510(k).
How long does a 510(k) take for product code OOU?
Across 5 cleared submissions the average was 93 days from receipt to decision (median 85).
Which companies have the most OOU clearances?
Hologic, Inc. (2); Quidel Corporation (1); Gen-Probe Prodesse, Inc. (1); Prodesse, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OOU
- Run a recall and safety report across every OOU manufacturer
- Watch product code OOU 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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