HSV IGM Test
by Gull Laboratories, Inc. 510(k)
Active
510(k) K830865
Overview
The HSV IGM Test is a fluorescent antisera diagnostic device designed for the detection of IgM antibodies to herpes simplex virus types 1 and 2 (HSV-1 and HSV-2). Classified under the nomenclature for antisera, this in vitro assay aids in the serological diagnosis of herpesvirus hominis infections by identifying recent or primary infections through the presence of IgM antibodies.
This test is supplied as a kit for laboratory use in microbiology settings and requires FDA 510(k) clearance (K830865). It is intended for single-use and must be handled according to standard laboratory protocols for serological testing. The device is regulated under the U.S. FDA as a Class II medical device under regulation number 866.3305, with no indication of MRI compatibility or sterility requirements beyond typical laboratory handling.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830865 | Date18 Jul 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GQL
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3305
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Gull Laboratories, Inc.
Questions
What is the HSV IGM Test used for in a clinical setting?
The HSV IGM Test is designed to detect IgM antibodies to herpes simplex virus types 1 and 2 (HSV-1 and HSV-2) in blood samples. This helps identify recent or primary infections by herpesvirus hominis, distinguishing them from past exposures where only IgG antibodies may be present. It is an in vitro diagnostic tool used in microbiology laboratories for serological testing.
Is the HSV IGM Test intended for single-use or repeated use?
The HSV IGM Test is explicitly intended for single-use only. Each kit is meant to be used once and discarded, following standard laboratory protocols for serological testing to ensure accuracy and prevent cross-contamination.
How is the HSV IGM Test supplied, and where is it manufactured?
The HSV IGM Test is supplied as a kit for laboratory use, tailored for microbiology settings. It is manufactured by Gull Laboratories, Inc., located at 803 N. Front St. Suite 3, McHenry, IL 60050, USA.
Does the HSV IGM Test require any special handling or storage conditions?
The HSV IGM Test does not specify unique sterility requirements beyond typical laboratory handling for serological tests. It should be stored and handled according to standard microbiology laboratory protocols to maintain its integrity and performance. No special storage conditions (e.g., refrigeration or temperature controls) are mentioned in the provided data.
What regulatory pathway was followed for the approval of the HSV IGM Test?
The HSV IGM Test received FDA clearance through a Traditional 510(k) pathway, classified under the Microbiology advisory committee (MI). The submission was determined Substantially Equivalent (SESE) to a predicate device and was filed on March 18, 1983, with clearance granted on July 18, 1983. The device is regulated under FDA regulation number 866.3305 and falls under the Class II medical device category.