K172126 is an FDA 510(k) clearance for the Xpert Xpress Strep A. 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 Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on September 25, 2017, 73 days after receiving the submission on July 14, 2017.
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 | K172126 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2017 |
| Decision Date | September 25, 2017 |
| Days to Decision | 73 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. |