Definition: The Candida Species Nucleic Acid Detection System Is A Qualitative Panel For The Direct Detection Of Candida Species In Whole Blood Specimens From Patients With Symptoms Of, Or Medical Conditions Predisposing The Patients To, Invasive Fungal Infectio
| Device Type ID | 3565 |
| Device Name | Candida Species Nucleic Acid Detection System |
| Physical State | The Candida Species Nucleic Acid Detection System Consists Of Reagents And Disposables And Accompanying Positive And Negative Controls. The Associated Instrumentation Performs The Amplification Of The Candida Nucleic Acid, Detects The Amplified Produ |
| Technical Method | A Multiplexed Nucleic Acid Amplification Assay That Amplifies And Detects Candida DNA In Whole Blood Specimens. |
| Target Area | Nucleic Acids Of Candida Species. |
| 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 | PII |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3565 |
| Device | Candida Species Nucleic Acid Detection System |
| Product Code | PII |
| 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 | ||
GRANTED | 1 | |
T2 BIOSYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | T2 Biosystems Inc | II | Sep-14-2016 |