510(k) · Cleared

Recalled · 2007

Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection System

K062213510(k) TraditionalCleared Dec 8, 2006129-day reviewClass I21 CFR 866.3235Recalls 1

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

Bio-Rad Laboratories, Inc. · LSE Epstein-Barr Virus, Other

Cleared on Dec 8, 2006 as substantially equivalent to K946157 (Incstar Corp., 1995) and 1 other predicate after a 129-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it. It has been recalled once.

Decided: Dec 8, 2006
Review: 129 days
Class: Class I
Product code: LSE
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K862008 (1986). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK862008 Mono-Latex (TM) Slide TestArmkel, LLC · 1986
This deviceK062213 Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection…Bio-Rad Laboratories, Inc. · 2006
Descendant · cites it directly · 0 of its ownK123021 Bioplex 2200 Ebv Igm KitBio-Rad Laboratories · 2012

Most influential descendants

Showing 1 of 1 · See all

K123021Bioplex 2200 Ebv Igm KitBio-Rad Laboratories · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K862008	Mono-Latex (TM) Slide Test	Armkel, LLC	1986	—
0 (this device)	K062213	Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection System	Bio-Rad Laboratories, Inc.	2006	—
+1	K123021	Bioplex 2200 Ebv Igm Kit	Bio-Rad Laboratories	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K062213, 1986–2012Source: 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? (2)

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
*	K946157	Incstar Epstein-Barr Viral Capsid Antigen (Vca) LGM Elisa Kit Summary page 2 …Decision IgG Analyte PREDICATE DEVICE Number Date 1. EBV VCA Diasorin EBV VCA IgM Capture EIA 946157 6/7/95 2. Heterophile Warnpole Monolatex 862008 7/03/86 DEVICE DESCRIPTION Th…	Incstar Corp.	1995	—
*	K862008	Mono-Latex (TM) Slide Test Summary page 2 …Date 1. EBV VCA Diasorin EBV VCA IgM Capture EIA 946157 6/7/95 2. Heterophile Warnpole Monolatex 862008 7/03/86 DEVICE DESCRIPTION The BioPlex 2200 EBV IgM kit uses multiplex flow immunoassay, a methodology that greatly rese…	Armkel, LLC	1986	—

Also cleared against K946157: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K123021	Bioplex 2200 Ebv Igm Kit	Bio-Rad Laboratories	2012	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 13, 2007	Not classified	Z-1158-2008	Nonconforming Material/Component	False negative results due to reagent packs exhibiting low signal.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K123021 (Bio-Rad Laboratories, 2012) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K946157.

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 BioPlex 2200 EBV IgM kit is a multiplex flow immunoassay intended for the qualitative detection of two (2) separate analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum. The test system can be used in conjunction with the BioPlex 2200 EBV IgG kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM). The EBV IgM kit is intended for use with the Bio-Rad BioPlex 2200…

Read the full statement (189 words)

The EBV IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.

Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas.

The BioPlex 2200 EBV IgM Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgM Reagent Pack.

The BioPlex 2200 EBV IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 EBV IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 EBV IgM Control Set has not been established with any other EBV assays.

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/K062213 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062213: Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062213

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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