510(k) · Cleared

Cleared

Ceruloplasmin, Model 2055953

K062114510(k) TraditionalCleared Jan 31, 2007191-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

Roche Diagnostics Corp. · CHN Immunochemical, Ceruloplasmin

Cleared on Jan 31, 2007 as substantially equivalent to K812486 (Dako Corp., 1981) after a 191-day review. Its family tree reaches back 1 generation to 1981. 1 later device descends from it.

Decided: Jan 31, 2007
Review: 191 days
Class: Class II
Product code: CHN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K812486 (1981). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK812486 Immunogl. FRCT. of Rabbit Antiser.-CerulDako Corp. · 1981
This deviceK062114 Ceruloplasmin, Model 2055953Roche Diagnostics Corp. · 2007
Descendant · cites it directly · 0 of its ownK091741 Tina-Quant CeruloplasminRoche Diagnostics · 2010

Most influential descendants

Showing 1 of 1 · See all

K091741Tina-Quant CeruloplasminRoche Diagnostics · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K812486	Immunogl. FRCT. of Rabbit Antiser.-Cerul	Dako Corp.	1981	—
0 (this device)	K062114	Ceruloplasmin, Model 2055953	Roche Diagnostics Corp.	2007	—
+1	K091741	Tina-Quant Ceruloplasmin	Roche Diagnostics	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K062114, 1981–2010Source: 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 CHN? 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
*	K812486	Immunogl. FRCT. of Rabbit Antiser.-Cerul Summary page 2 …RU3, 0-666). Predicate We claim substantial equivalence to the DakoCytomation assay for Device Polyclonal Rabbit Anti-Human Ceruloplasmin cleared as K812486. Substantial The table below indicates the similarities between the COBAS INTEGRA equivalency - Ceruloplasmin test an…	Dako Corp.	1981	—

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
K091741	Tina-Quant Ceruloplasmin	Roche Diagnostics	2010	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, K091741 (Roche Diagnostics, 2010) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CHN devices

CHN Immunochemical, Ceruloplasmin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · CHN

1in 2010

2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CHN

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

Recalls per year · CHN

6in 2017

2007high 6 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CHN

1in 2020

2007high 1 (2017) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	1	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	6	1
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	1
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

In vitro test for the quantitative immunological determination of ceruloplasmin in human serum and plasma on COBAS INTEGRA systems.

Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders.

In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche/Hitachi cobas c systems.

Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062114 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062114: Ceruloplasmin, Model 2055953.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062114

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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