510(k) Report

510(k) · Cleared

Cleared

miDiagnostics HSV-1&2 CSF Test

K250050510(k) TraditionalCleared Sep 30, 2025263-day reviewClass II21 CFR 866.3307

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Midiagnostics NV · PGH Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

Cleared on Sep 30, 2025 as substantially equivalent to DEN130049 (Focus Diagnostics, 2014) after a 263-day review. Its family tree reaches back 1 generation to 2014.

Decided
Sep 30, 2025
Review
263 days
Class
Class II
Product code
PGH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to DEN130049 (2014). No later device cites it as a predicate yet.

DEN130049 · Simplexa HSV 1&2 Direct · Focus Diagnostics · 20142010201520202025
DEN130049 · Simplexa HSV 1&2 Direct · Focus Diagnostics · 20140
  1. Root · 1 generation backDEN130049 Simplexa HSV 1&2 DirectFocus Diagnostics · 2014
  2. This deviceK250050 miDiagnostics HSV-1&2 CSF TestMidiagnostics NV · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN130049Simplexa HSV 1&2 DirectFocus Diagnostics2014—
0 (this device)K250050miDiagnostics HSV-1&2 CSF TestMidiagnostics NV2025—
FIG. 1 — Lineage of K250050, 2014–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PGH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*DEN130049Simplexa HSV 1&2 Direct
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.
Focus Diagnostics2014—

Also cleared against DEN130049: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate DEN130049.

How does its category compare?

All PGH devices

PGH Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · PGH

1in 2025

2014: 22025: 1
2007high 2 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PGH

Too few PGH 510(k)s in any year since 2007 to give a median.

Recalls per year · PGH

No recall names PGH since 2007.

Adverse event reports per year · PGH

No MAUDE report names PGH since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20142—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20251—00
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Also cleared against DEN130049

1 other device cites the same predicate.

  • K141458Simplexa HSV 1&2 Direct/Positive Control PackFocus Diagnostics · 20141 Class I recall

Recent decisions in PGH

The PGH category page

  • K141458Simplexa HSV 1&2 Direct/Positive Control PackFocus Diagnostics · 20141 Class I recall
  • DEN130049Simplexa HSV 1&2 DirectFocus Diagnostics · 2014

https://510kreport.com/device/K250050 · printed Nov 6, 2026

Cite this page

510(k) Report. “K250050: miDiagnostics HSV-1&2 CSF Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250050

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026