510(k) · Cleared

Cleared

Capture-CMV

K203612510(k) TraditionalCleared Mar 22, 2021102-day reviewClass II21 CFR 866.3175

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

Immucor, Inc. · LJO Antigen, Iha, Cytomegalovirus

Cleared on Mar 22, 2021 as substantially equivalent to K183571 (Immucor, Inc., 2019) after a 102-day review. Its family tree reaches back 2 generations to 1991.

Decided: Mar 22, 2021
Review: 102 days
Class: Class II
Product code: LJO
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K910003 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK910003 Cytomegalovirus Antibody ScreenImmucor, Inc. · 1991
1 generation backK183571 Capture-CMVImmucor, Inc. · 2019
This deviceK203612 Capture-CMVImmucor, Inc. · 2021

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K910003	Cytomegalovirus Antibody Screen	Immucor, Inc.	1991	—
−1	K183571	Capture-CMV	Immucor, Inc.	2019	—
0 (this device)	K203612	Capture-CMV	Immucor, Inc.	2021	—

FIG. 1 — Lineage of K203612, 1991–2021Source: 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 LJO? 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

Get a 510(k) Report

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
*	K183571	Capture-CMV Summary page 4 …Predicate Device Information Trade/Device Name: Capture-CMV® Clearance: K183571 (cleared February 4, 2019) Purpose of the Submission To demonstrate performance of the Capture-CMV® assay on the upg…	Immucor, Inc.	2019	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 30 years and passes through 1 company; a new generation was cleared every 27.9 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All LJO devices

LJO Antigen, Iha, Cytomegalovirus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · LJO

1in 2021

2007high 1 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJO

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

Recalls per year · LJO

No recall names LJO since 2007.

Adverse event reports per year · LJO

1in 2018

2007high 2 (2011) · low 0 (2007)2025

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

View these four charts as a table

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

What is it indicated for?

Capture-CMV® is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Capture-CMV® is intended to be used in screening of patients for serological evidence of previous infection by CMV using manual and semi-automated methods, NEO Iris® and Galileo NEO®.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K203612 · printed Nov 6, 2026

Cite this page

510(k) Report. “K203612: Capture-CMV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203612

Report an extraction error

Are you the manufacturer?

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