K233349 is an FDA 510(k) clearance for the Alinity m HSV 1 & 2 / VZV. 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 Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on May 3, 2024, 217 days after receiving the submission on September 29, 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 | K233349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2023 |
| Decision Date | May 03, 2024 |
| Days to Decision | 217 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. |