LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Microbiology · 21 CFR 866.3305 · Class 2
Overview
| Product Code | LGC |
|---|---|
| Device Name | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific |
| 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 38)
Showing 20 most recent of 38 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K033059 | HERPES GROUP IGG | Trinity Biotech, Inc. | Nov 26, 2003 | SESE |
| K010878 | MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 | Diagnostic Products Corp. | Apr 18, 2001 | SESE |
| K002262 | DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM | Diamedix Corp. | Nov 28, 2000 | SESE |
| K000238 | HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G | Mrl Diagnostics | Apr 14, 2000 | SESE |
| K992166 | THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | Zeus Scientific, Inc. | Sep 3, 1999 | SESE |
| K983886 | POCKIT HSV 2 RAPID TEST | Diagnology , Ltd. | Aug 19, 1999 | SESE |
| K984346 | PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST | Meridian Diagnostics, Inc. | Jun 25, 1999 | SESE |
| K983656 | HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM | Zeus Scientific, Inc. | Mar 18, 1999 | SESE |
| K983541 | HSV 1+2 IGG ELISA TEST | Gull Laboratories, Inc. | Feb 26, 1999 | SESE |
| K981306 | DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM | Diamedix Corp. | Sep 29, 1998 | SESE |
| K963645 | HERPES GROUP IGG ELISA TEST SYSTEM | Armkel, LLC | Feb 4, 1997 | SESE |
| K963282 | SERAQUEST HSV IGG | Quest Intl., Inc. | Jan 22, 1997 | SESE |
| K950670 | IMMULITE HERPES I AND II IGG | Diagnostic Products Corp. | Jun 21, 1996 | SESE |
| K953839 | PREMIER HSV PLUS | Meridian Diagnostics, Inc. | May 23, 1996 | SESE |
| K925208 | ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION | Ortho Diagnostic Systems, Inc. | Dec 28, 1992 | SESE |
| K922334 | BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA | Baxter Diagnostics, Inc. | Dec 15, 1992 | SESE |
| K922333 | BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA | Baxter Diagnostics, Inc. | Dec 15, 1992 | SESE |
| K922759 | HSV-2 IGM ELISA TEST--MODIFICATION | Gull Laboratories, Inc. | Oct 5, 1992 | SESE |
| K922758 | HSV-1 IGM ELISA TEST -- MODIFICATION | Gull Laboratories, Inc. | Oct 5, 1992 | SESE |
| K922583 | BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA | Baxter Diagnostics, Inc. | Sep 28, 1992 | SESE |
Top Applicants
- Gull Laboratories, Inc. — 7 clearances
- Baxter Diagnostics, Inc. — 4 clearances
- Ortho Diagnostic Systems, Inc. — 3 clearances
- Zeus Scientific, Inc. — 2 clearances
- Meridian Diagnostics, Inc. — 2 clearances
