510(k) DEN130049
DEN130049 is an FDA 510(k) premarket notification submitted by Focus Diagnostics for the device "SIMPLEXA HSV 1&2 DIRECT". The FDA issued a decision of De Novo Granted on March 21, 2014. The device falls under product code PGH (Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel), a Class II device regulated under 21 CFR 866.3307. Focus Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 21, 2014
- Date Received
- November 25, 2013
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
- Device Class
- Class II
- Regulation Number
- 866.3307
- Review Panel
- MI
- Submission Type
Intended for the qualitative detection and differentiation of HSV-1 and HSV-2 in cerebrospinal fluid (CSF) from patients with signs and symptoms of Herpes Simplex Virus (HSV) central nervous system (CNS) infection. This test is an aid in the diagnosis of HSV-1 and HSV-2 CNS infections in conjunction with other clinical and laboratory findings. Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.