510(k) · Cleared
ClearedPrecinorm Proteins in Urine/CSF (Puc) and Precipath Puc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · JIX Calibrator, Multi-Analyte Mixture
Cleared on Jan 31, 2005 as substantially equivalent to K040264 (Roche Diagnostics Corp., 2004) and 1 other predicate after a 25-day review. Its family tree reaches back 4 generations to 1987. 1 later device descends from it.
- Decided
- Jan 31, 2005
- Review
- 25 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K871027 (1987). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK871027 Precinorm (R) ProteinBoehringer Mannheim Corp. · 1987
- 3 generations backK981401 Boehringer Mannheim Precinorm Precipath Protein ControlsBoehringer Mannheim Corp. · 1998
- 2 generations backK040280 Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR…Roche Diagnostics Corp. · 2004
- 1 generation backK041812 Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF…Roche Diagnostics Corp. · 2004
- This deviceK050026 Precinorm Proteins in Urine/CSF (Puc) and Precipath PucRoche Diagnostics · 2005
- Descendant · cites it directly · 0 of its ownK071779 Abx Pentra Urine CalHoriba Abx · 2008
Most influential descendants
Showing 1 of 1 · See all- K071779Abx Pentra Urine CalHoriba Abx · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871027 | Precinorm (R) Protein | Boehringer Mannheim Corp. | 1987 | — |
| −3 | K981401 | Boehringer Mannheim Precinorm Precipath Protein Controls | Boehringer Mannheim Corp. | 1998 | — |
| −2 | 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 | — |
| 0 (this device) | K050026 | Precinorm Proteins in Urine/CSF (Puc) and Precipath Puc | Roche Diagnostics | 2005 | — |
| +1 | K071779 | Abx Pentra Urine Cal | Horiba Abx | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 JIX? 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? (2)
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 |
|---|---|---|---|
| * | K040264 | Calibrator for Automated Systems Proteins in Urine/CSFSummary page 2…sheet Device I For C.f.a.s. PUC, Roche claims substantial equivalence to the currently Substantial marketed currently marketed C.fa.s. PUC, K040264. Equivalence Substantial The table below compares C.fa.s. PUC with its predicate device (currently equivalence… | 2004 |
| * | K041812 | Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and Precipath…Summary page 3…C, Roche claims substantial Substantial equivalence to the currently marketed Roche Diagnostics Precinorm ® PUC Equivalence and Precipath ®PUC (K041812). Substantial The table below compares Precinorm ® PUC / Precipath® PUC with the Equivalence - predica… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071779 | Abx Pentra Urine Cal | 2008 | 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K071779 (Horiba Abx, 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 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.
C.fa.s. PUC is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050026: Precinorm Proteins in Urine/CSF (Puc) and Precipath Puc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050026
Report an extraction error
Are you the manufacturer?
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