510(k) K250050
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 2025
- Date Received
- January 10, 2025
- Clearance Type
- Traditional
- 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.