# PGI: Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

- Device class: 2; regulation: 21 CFR 866.3309; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 179 days (middle half 160–198)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 1
- 2015: 2
- 2016: 1
- 2018: 2
- 2019: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- K162451: Solana HSV 1+2/VZV Assay (2016), cited by 2
- K151906: ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD) (2015), cited by 1
- K151046: illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 (2015), cited by 1

Source page: https://510kreport.com/product-code/PGI
Data by year (CSV): https://510kreport.com/product-code/PGI.csv