Cleared Traditional

K250050 - miDiagnostics HSV-1&2 CSF Test

K250050 is an FDA 510(k) clearance for miDiagnostics HSV-1&2 CSF Test, manufactured by Midiagnostics NV. The device is a Class 2 Microbiology device with product code PGH cleared through the Traditional 510(k) pathway after a 263-day FDA review.

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

K250050 is an FDA 510(k) clearance for the miDiagnostics HSV-1&2 CSF Test. Classified as Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel (product code PGH), Class II - Special Controls.

Submitted by Midiagnostics NV (Leuven, BE). The FDA issued a Cleared decision on September 30, 2025 after a review of 263 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3307 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K250050

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 102d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PGH Device Classification - Class 2, Special Controls

Product Code PGH Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.