510(k) · Cleared

Cleared

N Antisera to Human Ceruloplasmin

K053074510(k) TraditionalCleared Mar 16, 2006135-day reviewClass II21 CFR 866.5210

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

Dade Behring, Inc. · DDB Ceruloplasmin, Antigen, Antiserum, Control

Cleared on Mar 16, 2006 as substantially equivalent to K860894 (Behring Diagnostics, Inc., 1986) after a 135-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.

Decided: Mar 16, 2006
Review: 135 days
Class: Class II
Product code: DDB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K860894 (1986). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK860894 Behring Nephelometer SystemBehring Diagnostics, Inc. · 1986
This deviceK053074 N Antisera to Human CeruloplasminDade Behring, Inc. · 2006
Descendant · cites it directly · 0 of its ownK161508 CeruloplasminBeckman Coulter Ireland, Inc. · 2017
Descendant · cites it directly · 0 of its ownK063655 Dimension Vista; Cer Flex Reagent Cartridge, Protein 1 Calibrator…Dade Behring, Inc. · 2007

Most influential descendants

Showing 2 of 2 · See all

K161508CeruloplasminBeckman Coulter Ireland, Inc. · 2017 · cites it directly0descendants
K063655Dimension Vista; Cer Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…Dade Behring, Inc. · 2007 · 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)	K053074	N Antisera to Human Ceruloplasmin	Dade Behring, Inc.	2006	—
+1	K161508	Ceruloplasmin	Beckman Coulter Ireland, Inc.	2017	—
+1	K063655	Dimension Vista; Cer Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1…	Dade Behring, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2017	1	0

FIG. 1 — Lineage of K053074, 1986–2017Source: 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 DDB? 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 …Immunology Product Code: DDB 3. Identification of the Legally Marketed Device: NAntisera to Human Ceruloplasmin- K860894 4. Device Description: Proteins contained in human body fluids form immune complexes in an immunochemical…	Behring Diagnostics, Inc.	1986	—

Also cleared against K860894: 16 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
K161508	Ceruloplasmin	Beckman Coulter Ireland, Inc.	2017	0
K063655	Dimension Vista; Cer Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…	Dade Behring, Inc.	2007	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, K161508 (Beckman Coulter Ireland, Inc., 2017) has gone furthest, with 0 descendants of its own.
16 other devices also cite its predicate K860894.

How does its category compare?

All DDB devices

DDB Ceruloplasmin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DDB

1in 2017

2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DDB

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

Recalls per year · DDB

No recall names DDB since 2007.

Adverse event reports per year · DDB

No MAUDE report names DDB since 2007.

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	—	0
2012	0	—	0
2013	1	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	1	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

In vitro diagnostic reagents for the quantitative determination of ceruloplasmin aid hemopexin in serum and heparinized plasma by means of immunonephelometery the BNTM Systems. Measurement of ceruloplasmin aids in the diagnosis of copper on metabolism disorders.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053074 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053074: N Antisera to Human Ceruloplasmin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053074

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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