K151906 is an FDA 510(k) clearance for the 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). 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 Luminex Corporation (Austin, US). The FDA issued a Cleared decision on October 6, 2015, 85 days after receiving the submission on July 13, 2015.
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 | K151906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2015 |
| Decision Date | October 06, 2015 |
| Days to Decision | 85 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. |