FDA product code PGI: Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
PGI is the FDA product code for herpes virus (vzv, hsv1, hsv2), dna detection assay for cutaneous and mucocutaneous lesion samples. It is a Class II device, regulated under 21 CFR 866.3309 and reviewed by the Microbiology panel. FDA has cleared 8 510(k) submissions under PGI, 2 in the last five years, from 6 different applicants. The average 510(k) review took 130 days (median 89); 217 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 2 recalls for PGI devices.
Definition
For the qualitative detection and differentiation of VZV, HSV1, HSV2- DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. The assay is not intended for use with cerebral spinal fluid.
Classification
| Field | Value |
|---|---|
| Device name | Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples |
| Device class | Class II |
| Regulation | 21 CFR 866.3309 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PGI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 166 |
| 2019 | 1 | 88 |
| 2023 | 1 | 141 |
| 2024 | 1 | 217 |
Compare with all 510(k) review times · Search every PGI clearance
Top PGI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quidel Corporation | 2 | 2023-12-20 |
| Diasorin Molecular, LLC | 2 | 2019-11-26 |
| Abbott Molecular, Inc. | 1 | 2024-05-03 |
| Elitechgroup | 1 | 2018-10-29 |
| Luminex Corporation | 1 | 2015-10-06 |
1 more applicants have PGI clearances. See the full list in Caduvo.
Most recent PGI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233349 | Abbott Molecular, Inc. | Alinity m HSV 1 & 2 / VZV | 2024-05-03 | 217 |
| K232286 | Quidel Corporation | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument | 2023-12-20 | 141 |
| K192376 | Diasorin Molecular, LLC | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack | 2019-11-26 | 88 |
| K180559 | Elitechgroup | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | 2018-10-29 | 242 |
| K173798 | Diasorin Molecular, LLC | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | 2018-03-14 | 90 |
Recalls for PGI devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2020-05-12.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code PGI?
PGI is the FDA product code for herpes virus (vzv, hsv1, hsv2), dna detection assay for cutaneous and mucocutaneous lesion samples. It is a Class II device, regulated under 21 CFR 866.3309 and reviewed by the Microbiology panel.
What device class is PGI?
Class II, regulation 21 CFR 866.3309. Typical premarket route: 510(k).
How long does a 510(k) take for product code PGI?
Across 8 cleared submissions the average was 130 days from receipt to decision (median 89).
Which companies have the most PGI clearances?
Quidel Corporation (2); Diasorin Molecular, LLC (2); Abbott Molecular, Inc. (1); Elitechgroup (1); Luminex Corporation (1).
Have PGI devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2020-05-12.
Next steps
- Run an FDA pathway report with predicate devices for product code PGI
- Run a recall and safety report across every PGI manufacturer
- Watch product code PGI 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times