DEN140019 is an FDA 510(k) submission for the T2CANDIDA AND T2DX INSTRUMENT. This device is classified as a Candida Species Nucleic Acid Detection System (Class II - Special Controls, product code PII).
Submitted by T2biosystems, Inc. (Lexington, US). The FDA issued a Not Cleared (DENG) decision on September 22, 2014.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3960. 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 Infections. The Test Is Indicated For The Presumptive Diagnosis Of Candidemia. The Test Is Performed Independent Of Blood Culture. Concomitant Blood Cultures Are Necessary To Recover Organisms For Susceptibility Testing Or Further Identification..
| 510(k) Number | DEN140019 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 27, 2014 |
| Decision Date | September 22, 2014 |
| Days to Decision | 118 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Product Code | PII - Candida Species Nucleic Acid Detection System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3960 |
| 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 Infections. The Test Is Indicated For The Presumptive Diagnosis Of Candidemia. The Test Is Performed Independent Of Blood Culture. Concomitant Blood Cultures Are Necessary To Recover Organisms For Susceptibility Testing Or Further Identification. |