510(k) · Cleared
ClearedTina-Quant Ceruloplasmin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · CHN Immunochemical, Ceruloplasmin
Cleared on Mar 18, 2010 as substantially equivalent to K062114 (Roche Diagnostics Corp., 2007) after a 275-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Mar 18, 2010
- Review
- 275 days
- Class
- Class II
- Product code
- CHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K812486 (1981). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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
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 | Decided |
|---|---|---|---|
| * | K062114 | Ceruloplasmin, Model 2055953Summary page 1…antially equivalent to the Roche equivalence Ceruloplasmin assay on the cobas c501 analyzer. The cobas c501 Ceruloplasmin assay was cleared under K0621 14. Page 1 of 4 Tina-quant Ceruloplasmin Assay 510(k) Summary, Continued Substantial equi… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 25.4 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All CHN devicesCHN Immunochemical, Ceruloplasmin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · CHN
1in 2010
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHN
1in 2020
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 determination of ceruloplasmin in human serum and
plasma on Roche automated clinical chemistry analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091741 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091741: Tina-Quant Ceruloplasmin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091741
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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