Herpes Simplex Virus Nucleic Acid Amplification Assay
The Herpes Simplex Virus Nucleic Acid Amplification Assay (product code OQO) is a PCR-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV) DNA in vaginal swab specimens. It is used in clinical laboratory settings to aid in the diagnosis of HSV infections. As an FDA Class 2 device under regulation 866.3305, it requires 510(k) premarket clearance and falls within the Microbiology specialty. The device carries no implant or life-sustaining flags and is not subject to third-party review.
Basic Information
- Product Code
- OQO
- Device Class
- FDA class 2
- Regulation Number
- 866.3305
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K172509 | Sentosa SA201 HSV 1/2 Qualitative PCR Test | Feb 01, 2018 | Substantially Equivalent | Vela Diagnostics USA, Inc. |
| K162673 | Aptima Herpes Simplex Viruses 1 & 2 Assay | Jun 15, 2017 | Substantially Equivalent | Hologic, Inc. |
| K150962 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | Aug 28, 2015 | Substantially Equivalent | Focus Diagnostics |
| K150617 | cobas HSV 1 and 2 Test | Jun 01, 2015 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K142156 | SEEGENE ANYPLEX II HSV-1/2 ASSAY | Feb 13, 2015 | Substantially Equivalent | Seegene |
| K142738 | artus HSV-1/2 QS-RGQ MDx Kit | Dec 19, 2014 | Substantially Equivalent | Qiagen |
| K140198 | IMDX HSV-1/2 FOR ABBOTT M2000 | May 13, 2014 | Substantially Equivalent | Intelligent Medical Devices, Inc. |
| K140029 | AMIPLIVUE HSV 1&2 ASSAY | Mar 26, 2014 | Substantially Equivalent | Quidel Corporation |
| K111951 | ISOAMP HSV ASSAY | Sep 27, 2011 | Substantially Equivalent | Biohelix Corporation |
| K111527 | MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT | Aug 03, 2011 | Substantially Equivalent | Eragen Biosciences, Inc. |
| K103798 | BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS | Mar 18, 2011 | Substantially Equivalent | Becton, Dickinson & CO |
| K100336 | MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 | May 12, 2010 | Substantially Equivalent | Eragen Biosciences |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.