510(k) · Cleared

Cleared

Vca Igg Elisa Test System

K980912510(k) TraditionalCleared Jul 22, 1998134-day reviewClass I21 CFR 866.3235

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

Clark Laboratories, Inc. · LSE Epstein-Barr Virus, Other

Cleared on Jul 22, 1998 after a 134-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Jul 22, 1998
Review: 134 days
Class: Class I
Product code: LSE
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK980912 Vca Igg Elisa Test SystemClark Laboratories, Inc. · 1998
Descendant · cites it directly · 1 of its ownK062211 Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection…Bio-Rad Laboratories, Inc. · 2006 · Recalled
Descendant · 2 generations on · 0 of its ownK120439 Bioplex 2200 Ebv Igg and Syphilis IggBio-Rad Laboratories, Inc. · 2012

Most influential descendants

Showing 2 of 2 · See all

K062211Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories, Inc. · 2006 · cites it directly1descendant
K120439Bioplex 2200 Ebv Igg and Syphilis IggBio-Rad Laboratories, Inc. · 2012 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K980912	Vca Igg Elisa Test System	Clark Laboratories, Inc.	1998	—
+1	K062211	Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection System	Bio-Rad Laboratories, Inc.	2006	2
+2	K120439	Bioplex 2200 Ebv Igg and Syphilis Igg	Bio-Rad Laboratories, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2012	1	0

FIG. 1 — Lineage of K980912, 1998–2012Source: FDA 510(k) summaries, read by 510(k) Report · 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 LSE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LSE device

#1 K233606 ADVIA Centaur EBV-VCA IgMscore 8.1 · 2 generations · no Class I recall

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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
*	—	EBV serology Named without a submission number			—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062211	Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection System	Bio-Rad Laboratories, Inc.	2006	1

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K062211 (Bio-Rad Laboratories, Inc., 2006) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LSE devices

LSE Epstein-Barr Virus, Other: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LSE

1in 2024

2007high 2 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LSE

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

Recalls per year · LSE

1in 2025

2007high 2 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LSE

1in 2014

2007high 1 (2014) · low 0 (2007)2025

MAUDE reports naming product code LSE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	2	0
2008	1	—	1	0
2009	1	—	0	0
2010	0	—	0	0
2011	0	—	1	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	1
2015	0	—	0	0
2016	0	—	0	0
2017	2	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	1	—	0	0
2025	0	—	1	0
2026	2	—	0	—

What is it indicated for?

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

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/K980912 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980912: Vca Igg Elisa Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980912

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Record history

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