DEN130032 is an FDA 510(k) submission for the XPERT MTB/RIF ASSAY. 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 Not Cleared (DENG) decision on July 25, 2013.
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 | DEN130032 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 11, 2013 |
| Decision Date | July 25, 2013 |
| Days to Decision | 44 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | — |
| 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. |