510(k) · Cleared

Cleared

Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) Reagent

K964842510(k) TraditionalCleared Jun 11, 1997190-day reviewClass II21 CFR 866.5240

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

Beckman Instruments, Inc. · CZW Complement C3, Antigen, Antiserum, Control

Cleared on Jun 11, 1997 as substantially equivalent to K771603 (Beckman Instruments, Inc., 1977) and 1 other predicate after a 190-day review. Its family tree reaches back 1 generation to 1977. 2 later devices descend from it.

Decided: Jun 11, 1997
Review: 190 days
Class: Class II
Product code: CZW
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K771603 (1977). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK771603 Immochemistry SystemBeckman Instruments, Inc. · 1977
This deviceK964842 Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4…Beckman Instruments, Inc. · 1997
Descendant · cites it directly · 0 of its ownK042494 Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20…Ortho-Clinical Diagnostics · 2004
Descendant · cites it directly · 0 of its ownK032035 Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems…Beckman Coulter, Inc. · 2003

Most influential descendants

Showing 2 of 2 · See all

K042494Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance…Ortho-Clinical Diagnostics · 2004 · cites it directly0descendants
K032035Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4)…Beckman Coulter, Inc. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K771603	Immochemistry System	Beckman Instruments, Inc.	1977	—
0 (this device)	K964842	Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) Reagent	Beckman Instruments, Inc.	1997	—
+1	K042494	Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein…	Ortho-Clinical Diagnostics	2004	—
+1	K032035	Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement…	Beckman Coulter, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0

FIG. 1 — Lineage of K964842, 1977–2004Source: 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 CZW? 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? (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
*	K771603	Immochemistry System Summary page 1 …Classification Name Complement components) immunological test system (21 CFR § 866.5240) Predicate Device!sl: Complement C3 (C3) Immunochemistry Beckman Instruments \| K771603 Reagent Systems Complement Inc. * C3 Reagent . Beckman Instruments Complement C4 (C4) Immunochemistry Inc.* K780913 Reagent Sy…	Beckman Instruments, Inc.	1977	—
*	K780913	Additional Reagents Kits for Imm. System Summary page 1 …ment C3 (C3) Immunochemistry Beckman Instruments \| K771603 Reagent Systems Complement Inc. * C3 Reagent . Beckman Instruments Complement C4 (C4) Immunochemistry Inc.* K780913 Reagent Systems Complement C4 Reagent Bechman Instruments, Inc. twx: 910-592-1260 « telex: 06-78413 Beckman In…	Beckman Instruments, Inc.	1978	—

Also cleared against K771603: 6 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K042494	Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance…	Ortho-Clinical Diagnostics	2004	0
K032035	Synchron LX Systems Complement C3 (C3) Reagent, Synchron LX Systems Complement C4 (C4)…	Beckman Coulter, Inc.	2003	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?

None of the 2 ancestors has a recall.
Of its descendants, K042494 (Ortho-Clinical Diagnostics, 2004) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K771603.

How does its category compare?

All CZW devices

CZW Complement C3, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CZW

1in 2010

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CZW

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

Recalls per year · CZW

No recall names CZW since 2007.

Adverse event reports per year · CZW

2in 2024

2007high 2 (2024) · low 0 (2007)2025

MAUDE reports naming product code CZW, 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	1	—	0
2008	0	—	0
2009	0	—	0
2010	1	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	1
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	2
2025	0	—	0
2026	0	—	—

What is it indicated for?

The IMMAGE Immunochemistry System Complement C4 (C4) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human complement C4 By rate nephelometry.

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/K964842 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964842: Immage Immunochemistry System COMPLEMENTC3 (C3) and COMPLEMENTC4 (C4) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964842

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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