K173398 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 April 26, 2018, 177 days after receiving the submission on October 31, 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 | K173398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2017 |
| Decision Date | April 26, 2018 |
| Days to Decision | 177 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. |