MXJ · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Microbiology · 21 CFR 866.3305 · Class 2
Overview
| Product Code | MXJ |
|---|---|
| Device Name | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| 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 (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls | Biokit, S.A. | Sep 20, 2023 | SESE |
| K220923 | Elecsys HSV-1 IgG (08948844160) | Roche Diagnostics | Oct 12, 2022 | SESE |
| K181333 | ADVIA Centaur Herpes-1 IgG | Biokit, S.A. | Aug 23, 2018 | SESE |
| K162276 | SeraQuest Herpes Type 1 Specific IgG | Quest International, Inc. | Oct 1, 2016 | SESE |
| K143236 | Theranos Herpes Simplex Virus-1 IgG Assay | Theranos, Inc. | Jul 2, 2015 | SESE |
| K131334 | HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST | Gold Standard Diagnostics | Feb 28, 2014 | SESE |
| K120625 | ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV | Roche Diagnostics | Jul 25, 2012 | SESE |
| K120959 | BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT | Bio-Rad Laboratories | Jun 22, 2012 | SESE |
| K103363 | ZEUS ELISA HSV GC-I IGG TEST SYSTEM | Zeus Scientific, Inc. | Apr 26, 2011 | SESE |
| K090409 | BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories | May 8, 2009 | SESE |
| K081685 | LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG | DiaSorin, Inc. | Nov 18, 2008 | SESE |
| K072178 | ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM | Zeus Scientific, Inc. | May 30, 2008 | SESE |
| K071511 | PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G | Focus Diagnostics, Inc. | Oct 5, 2007 | SESE |
| K071510 | HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 | Focus Diagnostics, Inc. | Sep 24, 2007 | SESE |
| K062543 | HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G | Focus Diagnostics, Inc. | Feb 1, 2007 | SESE |
| K033105 | CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT | Trinity Biotech USA | Jul 13, 2004 | SESE |
| K021486 | HERPESELECT 2 ELISA IGG, MODEL ELO920G | Focus Technologies, Inc. | Aug 1, 2002 | SESE |
| K021429 | HERPESELECT 1 ELISA IGG, MODEL EL0910G | Focus Technologies, Inc. | Jul 29, 2002 | SESE |
| K993754 | HSV-1 ELISA IGG, MODEL EL0910G | Mrl Diagnostics | Feb 9, 2000 | SESE |
| K984343 | PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST | Meridian Diagnostics, Inc. | Jun 25, 1999 | SESE |
Top Applicants
- Focus Diagnostics, Inc. — 3 clearances
- Bio-Rad Laboratories — 2 clearances
- Biokit, S.A. — 2 clearances
- Focus Technologies, Inc. — 2 clearances
- Roche Diagnostics — 2 clearances
