510(k) · Cleared

Cleared

Capture-CMV

K183571510(k) TraditionalCleared Feb 4, 201945-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 Feb 4, 2019 as substantially equivalent to K910003 (Immucor, Inc., 1991) after a 45-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.

Decided: Feb 4, 2019
Review: 45 days
Class: Class II
Product code: LJO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K910003 (1991). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK910003 Cytomegalovirus Antibody ScreenImmucor, Inc. · 1991
This deviceK183571 Capture-CMVImmucor, Inc. · 2019
Descendant · cites it directly · 0 of its ownK203612 Capture-CMVImmucor, Inc. · 2021

Most influential descendants

Showing 1 of 1 · See all

K203612Capture-CMVImmucor, Inc. · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0

FIG. 1 — Lineage of K183571, 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.

Top candidate predicates for a new LJO device

#1 K203612 Capture-CMVscore 1.3 · 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
*	K910003	Cytomegalovirus Antibody Screen Summary page 4 …I Classification Product Code: LJO Regulation Number: 21 CFR 866.3175 Predicate Device: Capture-CMV (K910003) 510(k) Number: K183571 Device Description and Intended Use Summary of the Test Cytomegalovirus…	Immucor, Inc.	1991	—

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
K203612	Capture-CMV	Immucor, Inc.	2021	0

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?

Its one ancestor has no recall.
Of its descendants, K203612 (Immucor, Inc., 2021) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LJO devices

LJO Antigen, Iha, Cytomegalovirus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 blood and plasma donors or patients for serological evidence of previous infection by CMV.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K183571 · printed Nov 6, 2026

Cite this page

510(k) Report. “K183571: 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/K183571

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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