510(k) · Cleared

Recalled · Class II · 2018

IS Ebv-EA-D Igg Elisa Test System

K981831510(k) TraditionalCleared Feb 16, 1999270-day reviewClass I21 CFR 866.3235Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Diamedix Corp. · GNP Antiserum, Cf, Epstein-Barr Virus

Cleared on Feb 16, 1999 after a 270-day review. The FDA summary names its predicate without a number. It has been recalled 2 times.

Decided: Feb 16, 1999
Review: 270 days
Class: Class I
Product code: GNP
Recalls: 2
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K981831Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GNP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	—	Wampole EA-D IgG ELISA Named without a submission number			—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 5, 2018	Class III	Z-2574-2018	Under Investigation by firm	Contains a gel-like contaminant that may affect product performance.
Oct 20, 2014	Class II	Z-1687-2016	Unknown/Undetermined by firm	A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.

No ancestor or descendant has a Class I recall.

How does its category compare?

All GNP devices

GNP Antiserum, Cf, Epstein-Barr Virus: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GNP

FDA has decided no GNP device since 2007.

Median 510(k) review, days · GNP

Too few GNP 510(k)s in any year since 2007 to give a median.

Recalls per year · GNP

No recall names GNP since 2007.

Adverse event reports per year · GNP

No MAUDE report names GNP since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

Read the full statement (110 words)

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K981831 · printed Nov 5, 2026

Cite this page

510(k) Report. “K981831: IS Ebv-EA-D Igg Elisa Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981831

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026