# K992191: Eti-EA-G Assay

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Jul 12, 1999 after 14 days
- Product code: LSE (Epstein-Barr Virus, Other)
- Device class: 1
- Regulation: 21 CFR 866.3235
- Recalls of this device: 1 (0 Class I)
- 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) DiaSorin EBV EA (D) IgG Clin-ELISA™: named in the summary without a submission number
- (no number) Gull Laboratories EBV EA IgG IFA: named in the summary without a submission number

## Most influential descendants
- K060204: Liaison EA Igg (2006), 1 descendant of its own
- K162959: LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set (2017), 0 descendants of its own

## Recalls of this device
- Nov 1, 2004 · Not classified · Z-0658-05: The DiaSorin ETI-EA-G kits contained the wrong microtiter plate. The plate provided in the kits was for a different product, the ProTrac II Tacrolimus kit.

## Indications for use
The DiaSorin ETI-EA-G kit uses Enzyme Linked Immunosorbent Assay (ELISA) technology for the qualitative and/or semi-quantitative detection of IgG antibodies to the EBV Early Antigen Diffuse. The assay is designed for human serum. The presence of EA antibodies is used as an aid in the diagnosis of EBV associated infectious mononucleosis when used in conjunction with other EBV serologies in pediatric, adult, transplant donor and transplant recipient populations. When evaluating properly paired sera, the results of these assays are used to demonstrate seroconversion or significant change in antibody titer as evidence of recent infection. Both specimens should be tested simultaneously.

Source page: https://510kreport.com/device/K992191
Methodology: https://510kreport.com/methodology