K101855 is an FDA 510(k) clearance for the PROFAST+ ASSAY. This device is classified as a 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification (Class II - Special Controls, product code OQW).
Submitted by Gen-Probe Prodesse, Inc. (Waukesha, US). The FDA issued a Cleared decision on July 23, 2010, 22 days after receiving the submission on July 1, 2010.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3332. 2009 H1n1 Influenza Virus Detection And Identification Reagents Are Used To Directly Detect And Differentiate The 2009 H1n1 Influenza Virus In Human Respiratory Specimens.
| 510(k) Number | K101855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2010 |
| Decision Date | July 23, 2010 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OQW — 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3332 |
| Definition | 2009 H1n1 Influenza Virus Detection And Identification Reagents Are Used To Directly Detect And Differentiate The 2009 H1n1 Influenza Virus In Human Respiratory Specimens |