OQO · Herpes Simplex Virus Nucleic Acid Amplification Assay
Microbiology · 21 CFR 866.3305 · Class 2
Overview
| Product Code | OQO |
|---|---|
| Device Name | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Regulation | 21 CFR 866.3305 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.
Classification Rationale
Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
Special Controls
*Classification.* Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K172509 | Sentosa SA201 HSV 1/2 Qualitative PCR Test | Vela Diagnostics USA, Inc. | Feb 1, 2018 | SESE |
| K162673 | Aptima Herpes Simplex Viruses 1 & 2 Assay | Hologic, Inc. | Jun 15, 2017 | SESE |
| K150962 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | Focus Diagnostics | Aug 28, 2015 | SESE |
| K150617 | cobas HSV 1 and 2 Test | Roche Molecular Systems, Inc. | Jun 1, 2015 | SESE |
| K142156 | SEEGENE ANYPLEX II HSV-1/2 ASSAY | Seegene | Feb 13, 2015 | SESE |
| K142738 | artus HSV-1/2 QS-RGQ MDx Kit | Qiagen | Dec 19, 2014 | SESE |
| K140198 | IMDX HSV-1/2 FOR ABBOTT M2000 | Intelligent Medical Devices, Inc. | May 13, 2014 | SESE |
| K140029 | AMIPLIVUE HSV 1&2 ASSAY | Quidel Corporation | Mar 26, 2014 | SESE |
| K111951 | ISOAMP HSV ASSAY | Biohelix Corporation | Sep 27, 2011 | SESE |
| K111527 | MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT | Eragen Biosciences, Inc. | Aug 3, 2011 | SESE |
| K103798 | BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS | Becton, Dickinson & CO | Mar 18, 2011 | SESE |
| K100336 | MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 | Eragen Biosciences | May 12, 2010 | SESE |
Top Applicants
- Becton, Dickinson & CO — 1 clearance
- Biohelix Corporation — 1 clearance
- Eragen Biosciences — 1 clearance
- Eragen Biosciences, Inc. — 1 clearance
- Focus Diagnostics — 1 clearance
