510(k) · Cleared
ClearedPrecinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR Controls
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 Mar 11, 2004 as substantially equivalent to K981401 (Boehringer Mannheim Corp., 1998) after a 34-day review. Its family tree reaches back 2 generations to 1987. 5 later devices descend from it.
- Decided
- Mar 11, 2004
- Review
- 34 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871027 (1987). 3 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK871027 Precinorm (R) ProteinBoehringer Mannheim Corp. · 1987
- 1 generation backK981401 Boehringer Mannheim Precinorm Precipath Protein ControlsBoehringer Mannheim Corp. · 1998
- This deviceK040280 Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR…Roche Diagnostics Corp. · 2004
- Descendant · cites it directly · 2 of its ownK041812 Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF…Roche Diagnostics Corp. · 2004
- Descendant · 2 generations on · 1 of its ownK050026 Precinorm Proteins in Urine/CSF (Puc) and Precipath PucRoche Diagnostics · 2005
- Descendant · cites it directly · 0 of its ownK132156 Randox CSF Controls Levels 2 and 3Randox Laboratories, Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK071779 Abx Pentra Urine CalHoriba Abx · 2008
- Descendant · cites it directly · 0 of its ownK062379 Cobas Integra CeruloplasminRoche Diagnostics Corp. · 2007
Most influential descendants
Showing 5 of 5 · See all- K041812Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and Precipath…Roche Diagnostics Corp. · 2004 · cites it directly2descendants
- K050026Precinorm Proteins in Urine/CSF (Puc) and Precipath PucRoche Diagnostics · 2005 · 2 generations on1descendant
- K132156Randox CSF Controls Levels 2 and 3Randox Laboratories, Ltd. · 2013 · cites it directly0descendants
- K071779Abx Pentra Urine CalHoriba Abx · 2008 · 3 generations on0descendants
- K062379Cobas Integra CeruloplasminRoche Diagnostics Corp. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871027 | Precinorm (R) Protein | Boehringer Mannheim Corp. | 1987 | — |
| −1 | K981401 | Boehringer Mannheim Precinorm Precipath Protein Controls | Boehringer Mannheim Corp. | 1998 | — |
| 0 (this device) | K040280 | Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR Controls | Roche Diagnostics Corp. | 2004 | — |
| +1 | K041812 | Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and… | Roche Diagnostics Corp. | 2004 | — |
| +2 | K050026 | Precinorm Proteins in Urine/CSF (Puc) and Precipath Puc | Roche Diagnostics | 2005 | — |
| +1 | K132156 | Randox CSF Controls Levels 2 and 3 | Randox Laboratories, Ltd. | 2013 | — |
| +3 | K071779 | Abx Pentra Urine Cal | Horiba Abx | 2008 | — |
| +1 | K062379 | Cobas Integra Ceruloplasmin | Roche Diagnostics Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K981401 | Boehringer Mannheim Precinorm Precipath Protein ControlsSummary page 2…evices legally marketed in the United States. We claim equivalence to the Roche Diagnostic Precinorm Protein Precipath Protein Controls. (K981401). The intended use of both devices is quality control of their respective test systems. Substantial The fol… | 1998 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 2 companies; a new generation was cleared every 11.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K041812 (Roche Diagnostics Corp., 2004) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K981401.
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.
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?
Precinorm PUC (Proteins in Urine/CSF) is for use in quality control by monitoring
accuracy and precision for the quantitative methods as specified in the enclosed value
sheet.
Precipath PUC (Proteins in Urine/CSF) is for use in 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/K040280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040280: Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040280
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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