510(k) · Cleared
ClearedC.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein & Precipath Protein
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 Nov 26, 2013 as substantially equivalent to K080607 (Roche Diagnostics Corp., 2008) and 3 other predicates after a 25-day review. Its family tree reaches back 4 generations to 1981.
- Decided
- Nov 26, 2013
- Review
- 25 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K811832 (1981). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK811832 Precinorm U & Precipath U Human SerumBoehringer Mannheim Corp. · 1981
- 3 generations backK993360 Precinorm Universal Plus and Precipath Universal Plus Control SeraRoche Diagnostics Corp. · 1999
- 2 generations backK042389 Modification to Precinorm Universal Plus and Precipath Universal…Roche Diagnostics Corp. · 2004
- 1 generation backK102016 Precicontrol Clinchem Multi 1 and 2Roche Diagnostics · 2010
- This deviceK133330 C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2…Roche Diagnostics · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K811832 | Precinorm U & Precipath U Human Serum | Boehringer Mannheim Corp. | 1981 | — |
| −3 | K993360 | Precinorm Universal Plus and Precipath Universal Plus Control Sera | Roche Diagnostics Corp. | 1999 | — |
| −2 | K042389 | Modification to Precinorm Universal Plus and Precipath Universal Plus Control… | Roche Diagnostics Corp. | 2004 | — |
| −1 | K102016 | Precicontrol Clinchem Multi 1 and 2 | Roche Diagnostics | 2010 | — |
| 0 (this device) | K133330 | C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm… | Roche Diagnostics | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 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? (4)
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 |
|---|---|---|---|
| * | K080607 | Calibrator for Automated Systems (C.F.a.S.) Proteins with Model 11355279160Summary page 2…rances Device 5 10O(k) Submission C.f.a.s. Proteins K080607 C.f.a.s. PAC K040245 PreciControl ClinChemn Mu… | 2008 |
| * | K040245 | Calibrator for Automated Systems Prealbumin-Aslo-Ceruloplasmin (C.F.a.S. Pac)Summary page 2…Submission C.f.a.s. Proteins K080607 C.f.a.s. PAC K040245 PreciControl ClinChemn Multi I and 2 K102016 Precinorm Protein and Pre… | 2004 |
| * | K102016 | Precicontrol Clinchem Multi 1 and 2Summary page 2…K080607 C.f.a.s. PAC K040245 PreciControl ClinChemn Multi I and 2 K102016 Precinorm Protein and Precipath Protein K981401 Regulatory Table 2: Regulatory Cla… | 2010 |
| * | K981401 | Boehringer Mannheim Precinorm Precipath Protein ControlsSummary page 2…K040245 PreciControl ClinChemn Multi I and 2 K102016 Precinorm Protein and Precipath Protein K981401 Regulatory Table 2: Regulatory Classification of Candidate Devices classification of Device C.f.a.s. Prote… | 1998 |
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 32 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
C.f.a.s. (Calibrator for automated systems) PAC (Prealbumin-ASLQ-Ceruioplasmin) is for usC inl the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the valuc sheets. C.f.a.s. (Calibrator for automated systems) Proteins is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. PreciControl ClinChem Multi I s for the use in quality…
Read the full statement (134 words)
C.f.a.s. (Calibrator for automated systems) PAC (Prealbumin-ASLQ-Ceruioplasmin) is for usC inl the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the valuc sheets.
C.f.a.s. (Calibrator for automated systems) Proteins is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
PreciControl ClinChem Multi I s for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in thle value sheets. PreciControl ClinChemn Multi 2 is for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Precinorm Protein and Precipath Protein are for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133330 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133330: C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein & Precipath Protein.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133330
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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