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 Diagnosi
| Device Type ID | 3560 |
| Device Name | System, Nucleic Acid-based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen |
| Physical State | In Vitro Diagnostic |
| Technical Method | Nested Real-time PCR. The [test] Must Be Used In Conjunction With Mycobacterial Culture To Address The Risk Of False Negative Results And To Recover The Organisms For Further Characterization And Drug Susceptibility Testing. The [test] Should Only Be |
| Target Area | Sputum |
| Regulation Description | Nucleic Acid-based In Vitro Diagnostic Devices For The Detection Of Mycobacterium Tuberculosis Complex (MTB-complex) And The Genetic Mutations Associated With MTB-complex Antibiotic Resistance In Respiratory Specimens. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3373 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PEU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3560 |
| Device | System, Nucleic Acid-based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen |
| Product Code | PEU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nucleic Acid-based In Vitro Diagnostic Devices For The Detection Of Mycobacterium Tuberculosis Complex (MTB-complex) And The Genetic Mutations Associated With MTB-complex Antibiotic Resistance In Respiratory Specimens. |
| CFR Regulation Number | 866.3373 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CEPHEID | ||
SUBSTANTIALLY EQUIVALENT | 1 | |