K150868 is an FDA 510(k) clearance for the Solana GAS Assay, Solana instrument. 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 June 23, 2015, 83 days after receiving the submission on April 1, 2015.
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 | K150868 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2015 |
| Decision Date | June 23, 2015 |
| Days to Decision | 83 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. |