510(k) · Cleared
ClearedCobas Integra Ceruloplasmin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jan 31, 2007 as substantially equivalent to K040280 (Roche Diagnostics Corp., 2004) after a 169-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Jan 31, 2007
- Review
- 169 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K871027 (1987). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK871027 Precinorm (R) ProteinBoehringer Mannheim Corp. · 1987
- 2 generations backK981401 Boehringer Mannheim Precinorm Precipath Protein ControlsBoehringer Mannheim Corp. · 1998
- 1 generation backK040280 Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR…Roche Diagnostics Corp. · 2004
- This deviceK062379 Cobas Integra CeruloplasminRoche Diagnostics Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871027 | Precinorm (R) Protein | Boehringer Mannheim Corp. | 1987 | — |
| −2 | K981401 | Boehringer Mannheim Precinorm Precipath Protein Controls | Boehringer Mannheim Corp. | 1998 | — |
| −1 | K040280 | Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR Controls | Roche Diagnostics Corp. | 2004 | — |
| 0 (this device) | K062379 | Cobas Integra Ceruloplasmin | Roche Diagnostics Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
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 JJY? 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 |
|---|---|---|---|
| * | K040280 | Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR ControlsSummary page 2…equivalence products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Precinorm PUG (K040280). Substantial The below tables compare Prealbumin/Ceruloplasmin Control Set with the equivalence: predicate… | 2004 |
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 20 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K040280.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Prealbumin/Ceruloplasmin Control Set (Precinorm/Precipath PC) is used for quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062379 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062379: Cobas Integra Ceruloplasmin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062379
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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