# K033106: Captia HSV 2 Igg Type Specific Elisa Kit

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Biotech USA
- Decided: Jul 13, 2004 after 287 days
- Product code: MYF (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2)
- 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) Western Blot: named in the summary without a submission number

## Indications for use
The Trinity Biotech Captia TM Herpes Simplex Virus (HSV) 2 Type Specific IgG kit is an Enzyme-linked Immunosorbent Assay (ELISA) intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-2 in human serum. In conjunction with the Trinity Biotech CaptiaT M Herpes Simplex Virus (HSV) 1 Type Specific IgG kit, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. Due to the implications of positive results, it is recommended they be confirmed in a low prevalence population with Western blot. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, or for use with automated equipment. The user is responsible for establishing assay performance in these populations and with automated equipment.

Source page: https://510kreport.com/device/K033106
Methodology: https://510kreport.com/methodology