K201269 is an FDA 510(k) clearance for the Accula Strep A Test. 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 Mesa Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on November 9, 2020, 181 days after receiving the submission on May 12, 2020.
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 | K201269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2020 |
| Decision Date | November 09, 2020 |
| Days to Decision | 181 days |
| Submission Type | Dual Track |
| 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. |