Proparaflu+ Assay
FDA 510(k) K132238 · Gen-Probe Prodesse, Inc.
510(k) numberK132238
Submission
- Device name
- Proparaflu+ Assay
- Applicant
- Gen-Probe Prodesse, Inc.
Waukesha, WI, US - Received
- July 18, 2013
- Decision date
- August 26, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OOU – Parainfluenza Multiplex Nucleic Acid Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
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…
Other 510(k)s with product code OOU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172282 | Panther Fusion Paraflu AssayOOU · Traditional | Hologic, Inc. | 10/23/2017SE |
| K153223 | ProParaFlu+ AssayOOU · Special | Hologic, Inc. | 12/09/2015SE |
| K141927 | Lyra Parainfluenza Virus AssayOOU · Traditional | Quidel Corporation | 10/09/2014SE |
| K091053 | Proparaflu+AssayOOU · Traditional | Prodesse, Inc. | 11/20/2009SE |
More from Prodesse, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K132237 | Prodesse Profast+ AssayOQW · Special | 08/26/2013SE |
| K132200 | Pro Hmpv+ AssayOEM · Special | 08/14/2013SE |
| K132159 | Proadeno+ AssayOCC · Special | 08/14/2013SE |
| K132129 | Prodesse Proflu+ AssayOCC · Special | 08/09/2013SE |
| K123838 | Pro Hmpv+ AssayOEM · Special | 01/16/2013SE |
| K123274 | Progastro SSCS AssayPCH · Traditional | 01/16/2013SE |
| K110968 | Proflu+ AssayOCC · Traditional | 06/27/2011SE |
| K102952 | Prodesse ProadenoOCC · Traditional | 12/03/2010SE |
| K101855 | Profast+ AssayOQW · Traditional | 07/23/2010SE |
Questions and answers
When was Proparaflu+ Assay cleared by the FDA?
Proparaflu+ Assay (K132238) received a 510(k) decision of Substantially Equivalent on August 26, 2013, 39 days after the submission was received.
What is the product code of K132238?
The FDA product code is OOU – Parainfluenza Multiplex Nucleic Acid Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3980.