K250050 is an FDA 510(k) clearance for the miDiagnostics HSV-1&2 CSF Test. This device is classified as a Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel (Class II - Special Controls, product code PGH).
Submitted by Midiagnostics NV (Leuven, BE). The FDA issued a Cleared decision on September 30, 2025, 263 days after receiving the submission on January 10, 2025.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3307. 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..
| 510(k) Number | K250050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 2025 |
| Decision Date | September 30, 2025 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PGH - Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3307 |
| Definition | 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. |