Definition: Amplification, Detection And Identification Of Microbial Pathogens Directly From Whole Blood Specimens
| Device Type ID | 3590 |
| Device Name | Direct Blood Bacterial Nucleic Acid Detection System |
| Physical State | The Direct Blood Bacterial Nucleic Acid Detection System Consists Of Reagents And Disposables. The Associated Instrumentation Performs The Amplification Of Bacterial Nucleic Acid, Detects The Amplified Products And Reports Results. |
| Technical Method | A Multiplexed Nucleic Acid Amplification Assay That Amplifies And Detects Bacterial DNA In Whole Blood Specimens |
| Target Area | Nucleic Acids Of Bacteria |
| Regulation Description | Nucleic Acid-based Device For The Amplification, Detection, And Identification Of Microbial Pathogens Directly From Whole Blood 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 | 866.3960 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QBX |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3590 |
| Device | Direct Blood Bacterial Nucleic Acid Detection System |
| Product Code | QBX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nucleic Acid-based Device For The Amplification, Detection, And Identification Of Microbial Pathogens Directly From Whole Blood Specimens. |
| CFR Regulation Number | 866.3960 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
T2 BIOSYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |