Prodesse Proflu+ Assay
FDA 510(k) K132129 · Gen-Probe Prodesse, Inc.
510(k) numberK132129
Submission
- Device name
- Prodesse Proflu+ Assay
- Applicant
- Gen-Probe Prodesse, Inc.
Waukesha, WI, US - Received
- July 10, 2013
- Decision date
- August 9, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCC – Respiratory Virus Panel Nucleic Acid Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of…
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More from Applied BioCode, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K132238 | Proparaflu+ AssayOOU · Special | 08/26/2013SE |
| K132237 | Prodesse Profast+ AssayOQW · Special | 08/26/2013SE |
| K132200 | Pro Hmpv+ AssayOEM · Special | 08/14/2013SE |
| K132159 | Proadeno+ AssayOCC · Special | 08/14/2013SE |
| 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 Prodesse Proflu+ Assay cleared by the FDA?
Prodesse Proflu+ Assay (K132129) received a 510(k) decision of Substantially Equivalent on August 9, 2013, 30 days after the submission was received.
What is the product code of K132129?
The FDA product code is OCC – Respiratory Virus Panel Nucleic Acid Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.