K222638 is an FDA 510(k) clearance for the Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems. This device is classified as a Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (Class I - General Controls, product code NJR).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on September 27, 2023, 391 days after receiving the submission on September 1, 2022.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740. A Nucleic Acid Amplification Assay System (including Probes, Other Reagents, And Instrumentation) Is An Aid In The Identification Of Group B Streptococci From Pre-partum And Intra-partum Women To Establish Colonization Status..
| 510(k) Number | K222638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2022 |
| Decision Date | September 27, 2023 |
| Days to Decision | 391 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | NJR — Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |
| Definition | A Nucleic Acid Amplification Assay System (including Probes, Other Reagents, And Instrumentation) Is An Aid In The Identification Of Group B Streptococci From Pre-partum And Intra-partum Women To Establish Colonization Status. |