MYF · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Microbiology · 21 CFR 866.3305 · Class 2
Overview
| Product Code | MYF |
|---|---|
| Device Name | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 |
| 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 (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | Biokit, S.A. | Feb 12, 2025 | SESE |
| K220924 | Elecsys HSV-2 IgG (08948887160) | Roche Diagnostics | Oct 12, 2022 | SESE |
| K181514 | SeraQuest HSV Type 2 Specific IgG | Quest International, Inc. | Jun 13, 2019 | SESE |
| K181334 | ADVIA Centaur Herpes-2 IgG | Biokit, S.A. | Aug 23, 2018 | SESE |
| K152353 | SeraQuest HSV Type 2 Specific IgG | Quest International, Inc. | May 13, 2016 | SESE |
| K103603 | ZEUS ELISA HSV GG-2 IGG TEST SYSTEM | Zeus Scientific, Inc. | May 20, 2011 | SESE |
| K081687 | LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG | DiaSorin, Inc. | Nov 10, 2008 | SESE |
| K061239 | EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT | Euroimmun Us, LLC | Jun 28, 2007 | SESE |
| K033106 | CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT | Trinity Biotech USA | Jul 13, 2004 | SESE |
| K993724 | HSV-2 ELISA IGG, MODEL EL0920G | Mrl Diagnostics | Feb 1, 2000 | SESE |
Top Applicants
- Biokit, S.A. — 2 clearances
- Quest International, Inc. — 2 clearances
- DiaSorin, Inc. — 1 clearance
- Euroimmun Us, LLC — 1 clearance
- Mrl Diagnostics — 1 clearance
