Cleared Traditional

miDiagnostics HSV-1&2 CSF Test

K250050 · Midiagnostics NV · Microbiology
Sep 2025
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K250050 is an FDA 510(k) clearance for the miDiagnostics HSV-1&2 CSF Test, 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 review panel. Regulated under 21 CFR 866.3307.

Submission Details

510(k) Number K250050 FDA.gov
FDA Decision Cleared 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

Device Classification

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.