# K981831: IS Ebv-EA-D Igg Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diamedix Corp.
- Decided: Feb 16, 1999 after 270 days
- Product code: GNP (Antiserum, Cf, Epstein-Barr Virus)
- Device class: 1
- Regulation: 21 CFR 866.3235
- Recalls of this device: 2 (0 Class I)
- 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) Wampole EA-D IgG ELISA: named in the summary without a submission number

## Recalls of this device
- Jan 5, 2018 · Class III · Z-2574-2018: Contains a gel-like contaminant that may affect product performance.
- Oct 20, 2014 · Class II · Z-1687-2016: A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.

## Indications for use
For the qualitative and semi-quantitative determination of IgG antibodies to Epstein-Barr Virus (recombinant) Early Antigen Diffuse (EBV-EA-D IgG) in human serum by indirect enzyme immunoassay. The Is-EBV-EA-D IgG Test Kit may be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgG and IgM, Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgG and IgM, Early Antigen-Diffuse (EA-D) IgM and heterophile antibody as an aid in the diagnosis of infectious mononucleosis (IM). The evaluation of paired sera, to determine a significant increase in EA-D IgG antibody titer, can also aid in the diagnosis of acute infection. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated Processor.

Source page: https://510kreport.com/device/K981831
Methodology: https://510kreport.com/methodology