OQO — Herpes Simplex Virus Nucleic Acid Amplification Assay Class II
FDA product code OQO covers "Herpes Simplex Virus Nucleic Acid Amplification Assay", a Class II medical device regulated under 21 CFR 866.3305. Submissions are reviewed by the Microbiology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OQO
- Device Class
- Class II
- Regulation Number
- 866.3305
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172509 | vela diagnostics usa | Sentosa SA201 HSV 1/2 Qualitative PCR Test | February 1, 2018 |
| K162673 | hologic | Aptima Herpes Simplex Viruses 1 & 2 Assay | June 15, 2017 |
| K150962 | focus diagnostics | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | August 28, 2015 |
| K150617 | roche molecular systems | cobas HSV 1 and 2 Test | June 1, 2015 |
| K142156 | seegene | SEEGENE ANYPLEX II HSV-1/2 ASSAY | February 13, 2015 |
| K142738 | qiagen | artus HSV-1/2 QS-RGQ MDx Kit | December 19, 2014 |
| K140198 | intelligent medical devices | IMDX HSV-1/2 FOR ABBOTT M2000 | May 13, 2014 |
| K140029 | quidel corporation | AMIPLIVUE HSV 1&2 ASSAY | March 26, 2014 |
| K111951 | biohelix corporation | ISOAMP HSV ASSAY | September 27, 2011 |
| K111527 | eragen biosciences | MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT | August 3, 2011 |
| K103798 | becton, dickinson and | BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS | March 18, 2011 |
| K100336 | eragen biosciences | MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 | May 12, 2010 |