K232286 is an FDA 510(k) clearance for the Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument. This device is classified as a Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples (Class II - Special Controls, product code PGI).
Submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on December 20, 2023, 141 days after receiving the submission on August 1, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3309. 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..
| 510(k) Number | K232286 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2023 |
| Decision Date | December 20, 2023 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PGI — Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3309 |
| 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. |