K143302 is an FDA 510(k) clearance for the Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80. This device is classified as a System, Nucleic Acid-based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen (Class II - Special Controls, product code PEU).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on February 12, 2015, 87 days after receiving the submission on November 17, 2014.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3373. The [test] Is Intended For Use With Specimens From Patients For Whom There Is Clinical Suspicion Of Tuberculosis (tb) And Who Have Received No Antituberculosis Therapy, Or Less Than 3 Days Of Therapy. This [test] Is Intended As An Aid In The Diagnosis Of Pulmonary Tuberculosis When Used In Conjunction With Clinical And Other Laboratory Findings..
| 510(k) Number | K143302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2014 |
| Decision Date | February 12, 2015 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PEU — System, Nucleic Acid-based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3373 |
| Definition | The [test] Is Intended For Use With Specimens From Patients For Whom There Is Clinical Suspicion Of Tuberculosis (tb) And Who Have Received No Antituberculosis Therapy, Or Less Than 3 Days Of Therapy. This [test] Is Intended As An Aid In The Diagnosis Of Pulmonary Tuberculosis When Used In Conjunction With Clinical And Other Laboratory Findings. |