# K981306: Diamedix IS-HSV 1 & 2 Igg Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diamedix Corp.
- Decided: Sep 29, 1998 after 172 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) Incstar HSV VII IgG "fast" ELISA Kit: named in the summary without a submission number

## Indications for use
The Diamedix Is-HSV 1 & 2 IgG is an indirect Enzyme Immunoassay (EIA) for the qualitative and semi-quantitative determination of IgG antibodies to herpes simplex virus (HSV) type 1 and/ or type 2 in human serum. This test is useful for indicating a past infection with HSV in a single specimen, including females of child-bearing age. The evaluation of acute and convalescent specimens, by demonstrating seroconversion or a significant increase in antibody level, can aid in the diagnosis of primary infection with HSV. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

Source page: https://510kreport.com/device/K981306
Methodology: https://510kreport.com/methodology