510(k) · Cleared

Cleared

N Antisera to Human Complement Factors (C3C, C4)

K050665510(k) TraditionalCleared May 2, 200548-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

Dade Behring, Inc. · CZW Complement C3, Antigen, Antiserum, Control

Cleared on May 2, 2005 as substantially equivalent to K860894 (Behring Diagnostics, Inc., 1986) after a 48-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.

Decided: May 2, 2005
Review: 48 days
Class: Class II
Product code: CZW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K860894 (1986). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK860894 Behring Nephelometer SystemBehring Diagnostics, Inc. · 1986
This deviceK050665 N Antisera to Human Complement Factors (C3C, C4)Dade Behring, Inc. · 2005
Descendant · cites it directly · 0 of its ownK061852 Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1…Dade Behring, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all

K061852Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low…Dade Behring, Inc. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K860894	Behring Nephelometer System	Behring Diagnostics, Inc.	1986	—
0 (this device)	K050665	N Antisera to Human Complement Factors (C3C, C4)	Dade Behring, Inc.	2005	—
+1	K061852	Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator…	Dade Behring, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0

FIG. 1 — Lineage of K050665, 1986–2006Source: 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? (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
*	K860894	Behring Nephelometer System Summary page 1 …C3, C4 immunological test system, Class 11 (866.5240) 3. Identification of the Legally Marketed Device: N Antisera to Human Complement Factors (C3c and C4), K860894 4. Device Description: Proteins contained in human body fluids form immune complexes in an immunochemical re…	Behring Diagnostics, Inc.	1986	—

Also cleared against K860894: 16 other devices →

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
K061852	Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low…	Dade Behring, Inc.	2006	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, K061852 (Dade Behring, Inc., 2006) has gone furthest, with 0 descendants of its own.
16 other devices also cite its predicate K860894.

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?

In vitro diagnostic reagents for the quantitative determination of complement factors (C3/C3c and C4/C4c) in human serum or heparinized or EDTA plasma by means of immunonephelometry on the BN* Systems as an aid in the diagnosis of immunologic disorders associated with complement C3 or C4 protein.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050665 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050665: N Antisera to Human Complement Factors (C3C, C4).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050665

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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