# K973123: EA-D Igg Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Clark Laboratories, Inc.
- Decided: Mar 26, 1998 after 218 days
- Product code: LSE (Epstein-Barr Virus, Other)
- Device class: 1
- Regulation: 21 CFR 866.3235
- 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) EBV serology: named in the summary without a submission number

## Most influential descendants
- K062211: Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection System (2006), 1 descendant of its own
- K120439: Bioplex 2200 Ebv Igg and Syphilis Igg (2012), 0 descendants of its own

## Indications for use
The Epstein-Barr Early Antigen Diffuse component (EA-D) IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to EA-D antigen. The Clark anti-EA-D IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis.

Source page: https://510kreport.com/device/K973123
Methodology: https://510kreport.com/methodology