K140029 is an FDA 510(k) clearance for the AMIPLIVUE HSV 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 Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on March 26, 2014, 79 days after receiving the submission on January 6, 2014.
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 | K140029 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 2014 |
| Decision Date | March 26, 2014 |
| Days to Decision | 79 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. |