510(k) · Cleared
ClearedModification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and Precipath Proteins in Urine/CSF (Puc)
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 Jul 27, 2004 as substantially equivalent to K040280 (Roche Diagnostics Corp., 2004) after a 21-day review. Its family tree reaches back 3 generations to 1987. 2 later devices descend from it.
- Decided
- Jul 27, 2004
- Review
- 21 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. 2 later devices descend from it, 1 citing it directly.
- 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 deviceK041812 Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF…Roche Diagnostics Corp. · 2004
- Descendant · cites it directly · 1 of its ownK050026 Precinorm Proteins in Urine/CSF (Puc) and Precipath PucRoche Diagnostics · 2005
- Descendant · 2 generations on · 0 of its ownK071779 Abx Pentra Urine CalHoriba Abx · 2008
Most influential descendants
Showing 2 of 2 · See allView 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) | K041812 | Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and… | Roche Diagnostics Corp. | 2004 | — |
| +1 | K050026 | Precinorm Proteins in Urine/CSF (Puc) and Precipath Puc | Roche Diagnostics | 2005 | — |
| +2 | K071779 | Abx Pentra Urine Cal | Horiba Abx | 2008 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 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…e claims substantial equivalence to the currently marketed Roche Equivalence Diagnostics Precinorm ®Universal and Precipath ® Universal Control Sera (K040280). Substantial The table below compares Precinorm ®PUC / Precipath® PUC with the Equivalence - predicate device (currently… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050026 | Precinorm Proteins in Urine/CSF (Puc) and Precipath Puc | 2005 | 1 |
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 5.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K050026 (Roche Diagnostics, 2005) has gone furthest, with 1 descendant of its own.
- 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.
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/K041812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041812: Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and Precipath Proteins in Urine/CSF (Puc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041812
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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