K173798 is an FDA 510(k) clearance for the Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack. 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 Diasorin Molecular, LLC (Cypress, US). The FDA issued a Cleared decision on March 14, 2018, 90 days after receiving the submission on December 14, 2017.
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 | K173798 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2017 |
| Decision Date | March 14, 2018 |
| Days to Decision | 90 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. |