# K984346: Premier Type Specific HSV-2 Igg Elisa Test

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Diagnostics, Inc.
- Decided: Jun 25, 1999 after 203 days
- Product code: LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific)
- Device class: 2
- Regulation: 21 CFR 866.3305
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) HSV-2 IgG ELISA Test: named in the summary without a submission number

## Indications for use
The PREMIER™ TYPE SPECIFIC HSV-2 IgG ELISA TEST is to be used in the testing of human serum specimens from individuals for whom the qualitative presence or absence of detectable IgG antibody to herpes simplex virus type 2 is warranted; specifically, when used in conjunction with the Premier™ Type Specific HSV-1 IgG ELISA in the screening of sexually active adults. This test is indicated for individuals at risk for a sexually transmitted HSV infection or disease (STD). For example, this test is to be used to screen samples from patients with or without clinical history of herpes and can clarify when an individual with symptoms suggestive of genital herpes has genital HSV-2 infection. The PREMIER™ TYPE SPECIFIC HSV-2 IgG ELISA TEST is not recommended for use in a pediatric population. The performance characteristics of this device have not been established for prenatal and neonatal screening, the testing of patients with other HSV associated diseases and . immunosuppressed patients, or the detection of early stages of HSV seroconversion.

Source page: https://510kreport.com/device/K984346
Methodology: https://510kreport.com/methodology