# K021429: Herpeselect 1 Elisa Igg, Model EL0910G

- Pathway: 510(k) (Traditional)
- Applicant: Focus Technologies, Inc.
- Decided: Jul 29, 2002 after 87 days
- Product code: MXJ (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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) HerpeSelect®1 ELISA IgG (manual option): named in the summary without a submission number

## Most influential descendants
- K090409: Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection System (2009), 1 descendant of its own
- K120959: Bioplex 2200 HSV-1 and HSV-2 Igg Kit (2012), 0 descendants of its own

## Indications for use
Focus Technologies' Herpeselect® 1 ELISA IgG test is intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 in human sera. In conjunction with the Focus Herpeselect® 2 ELISA IgG, the test is indicated for testing sexually active adults or expectant mothers for aiding in the presumptive diagnosis of HSV infection. The assay can be used manually or in conjunction with an automated system as outlined in the package insert. The user is responsible for assay performance characteristics when an automated system is used. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.

Source page: https://510kreport.com/device/K021429
Methodology: https://510kreport.com/methodology