510(k) Report

FDA product code · Microbiology

Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

PGHClass II21 CFR 866.3307510(k) required3 decisions since 20140 recalls

3 FDA decisions since 2014. 510(k) reviews decided 2021–2025 took a median of 263 days (half between 263 and 263). No recall names this code. The most-cited predicate is DEN130049, named by 2 later devices.

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…

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

FIG. A — Illustration, microbiology panel

Twenty years of PGH at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — PGH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PGH? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PGH devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • DEN130049Simplexa HSV 1&2 DirectFocus Diagnostics · 20142cite it

Which PGH devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K250050miDiagnostics HSV-1&2 CSF TestMidiagnostics NV · 20251generation
  • K141458Simplexa HSV 1&2 Direct/Positive Control PackFocus Diagnostics · 20141generation

What has FDA decided in PGH lately?

  • K250050miDiagnostics HSV-1&2 CSF TestMidiagnostics NV · 2025
  • K141458Simplexa HSV 1&2 Direct/Positive Control PackFocus Diagnostics · 20141 Class I recall
  • DEN130049Simplexa HSV 1&2 DirectFocus Diagnostics · 2014

All 3 PGH decisions →