510(k) DEN160016
DEN160016 is an FDA 510(k) premarket notification submitted by Centers For Disease Control and Prevention (CDC) for the device "Variola virus Real-Time PCR Assay". The FDA issued a decision of De Novo Granted on February 6, 2017. The device falls under product code PRA (Variola Virus Nucleic Acid-Based Detection Assay), a Class II device regulated under 21 CFR 866.3316. Centers For Disease Control and Prevention (CDC) has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 6, 2017
- Date Received
- April 14, 2016
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Variola Virus Nucleic Acid-Based Detection Assay
- Device Class
- Class II
- Regulation Number
- 866.3316
- Review Panel
- MI
- Submission Type
The Variola virus nucleic acid-based detection assay is intended for individuals presenting with pustular or vesicular rash illness or other signs and symptoms of Variola virus infection. The test results must be used in conjunction with other diagnostic assays and clinical observations, as an aid to the diagnosis of infection, in accordance with the criteria defined by the appropriate public health authorities with the Federal government.