K162673 is an FDA 510(k) clearance for the Aptima Herpes Simplex Viruses 1 & 2 Assay. This device is classified as a Herpes Simplex Virus Nucleic Acid Amplification Assay (Class II - Special Controls, product code OQO).
Submitted by Hologic, Inc. (San Diego, US). The FDA issued a Cleared decision on June 15, 2017, 262 days after receiving the submission on September 26, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305. A Polymerase Chain Reaction (pcr)-based Qualitative In Vitro Diagnostic Test For The Detection And Typing Of Herpes Simplex Virus (hsv) Dna Using Vaginal Swab Specimens..
| 510(k) Number | K162673 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2016 |
| Decision Date | June 15, 2017 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OQO — Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |
| Definition | A Polymerase Chain Reaction (pcr)-based Qualitative In Vitro Diagnostic Test For The Detection And Typing Of Herpes Simplex Virus (hsv) Dna Using Vaginal Swab Specimens. |