# K033059: Herpes Group Igg

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Biotech, Inc.
- Decided: Nov 26, 2003 after 58 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) Clark Laboratories, Inc. HSV I ELISA test: named in the summary without a submission number
- (no number) Clark Laboratories, Inc. HSV II ELISA test: named in the summary without a submission number

## Indications for use
The Trinity Biotech CaptiaTM Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to determine serologic status in females of child bearing age, and to evaluate paired sera for the presence of a seroconversion of IgG as an aid in the diagnosis of Herpes simplex virus infection. It is not intended for determining the type of Herpes simplex virus.

Source page: https://510kreport.com/device/K033059
Methodology: https://510kreport.com/methodology