PGI — Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples Class II
FDA product code PGI covers "Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples", a Class II medical device regulated under 21 CFR 866.3309. Submissions are reviewed by the Microbiology panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PGI
- Device Class
- Class II
- Regulation Number
- 866.3309
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233349 | abbott molecular | Alinity m HSV 1 & 2 / VZV | May 3, 2024 |
| K232286 | quidel corporation | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument | December 20, 2023 |
| K192376 | diasorin molecular | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack | November 26, 2019 |
| K180559 | elitechgroup | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | October 29, 2018 |
| K173798 | diasorin molecular | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | March 14, 2018 |
| K162451 | quidel corporation | Solana HSV 1+2/VZV Assay | November 28, 2016 |
| K151906 | luminex corporation | ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol | October 6, 2015 |
| K151046 | meridian bioscience | illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control | July 17, 2015 |
| DEN140004 | diagnostic hybrids | QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY | May 13, 2014 |