FDA product code PGH: Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
PGH is the FDA product code for hsv-1 and hsv-2 cns nucleic-acid based panel. It is a Class II device, regulated under 21 CFR 866.3307 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under PGH, 1 in the last five years, from 2 different applicants. The average 510(k) review took 146 days (median 146); 263 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for PGH devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel |
| Device class | Class II |
| Regulation | 21 CFR 866.3307 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for PGH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 263 |
Compare with all 510(k) review times · Search every PGH clearance
Top PGH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Midiagnostics NV | 1 | 2025-09-30 |
| Focus Diagnostics | 1 | 2014-07-01 |
Most recent PGH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250050 | Midiagnostics NV | miDiagnostics HSV-1&2 CSF Test | 2025-09-30 | 263 |
| K141458 | Focus Diagnostics | SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK | 2014-07-01 | 29 |
Recalls for PGH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-02-10.
Frequently asked questions
What is FDA product code PGH?
PGH is the FDA product code for hsv-1 and hsv-2 cns nucleic-acid based panel. It is a Class II device, regulated under 21 CFR 866.3307 and reviewed by the Microbiology panel.
What device class is PGH?
Class II, regulation 21 CFR 866.3307. Typical premarket route: 510(k).
How long does a 510(k) take for product code PGH?
Across 2 cleared submissions the average was 146 days from receipt to decision (median 146).
Which companies have the most PGH clearances?
Midiagnostics NV (1); Focus Diagnostics (1).
Have PGH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-02-10.
Next steps
- Run an FDA pathway report with predicate devices for product code PGH
- Run a recall and safety report across every PGH manufacturer
- Watch product code PGH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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