# K250050: miDiagnostics HSV-1&2 CSF Test

- Pathway: 510(k) (Traditional)
- Applicant: Midiagnostics NV
- Decided: Sep 30, 2025 after 263 days
- Product code: PGH (Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel)
- Device class: 2
- Regulation: 21 CFR 866.3307
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN130049 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130049: Simplexa HSV 1&2 Direct, Focus Diagnostics (2014). Our reading of the summary gave K133621, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130049, Simplexa HSV 1&2 Direct (Focus Diagnostics), granted Mar 21, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Indications for use
The miDiagnostics HSV-1&2 CSF Test is an in vitro polymerase chain reaction (PCR) assay intended for use with the miDiagnostics PCR Platform for the qualitative detection and differentiation of HSV-1 and HSV-2 DNA in cerebrospinal fluid (CSF) samples from patients suspected of Herpes Simplex Virus (HSV) infection of the central nervous system (CNS). This test is intended as an aid in the diagnosis of HSV-1 and HSV-2 infection in the CNS. 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. The test is not intended for use as a donor screening test. The test is for professional use only.

Source page: https://510kreport.com/device/K250050
Methodology: https://510kreport.com/methodology