K162274 is an FDA 510(k) clearance for the Solana Strep Complete Assay. This device is classified as a Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (Class II - Special Controls, product code PGX).
Submitted by Quidel Corporation (Athens, US). The FDA issued a Cleared decision on October 25, 2016, 74 days after receiving the submission on August 12, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2680. An In Vitro Diagnostic Test For The Detection Of Group A, C And G Beta Hemolytic Streptococcus In Throat Swab Specimens From Symptomatic Patients..
| 510(k) Number | K162274 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2016 |
| Decision Date | October 25, 2016 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PGX — Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.2680 |
| Definition | An In Vitro Diagnostic Test For The Detection Of Group A, C And G Beta Hemolytic Streptococcus In Throat Swab Specimens From Symptomatic Patients. |