510(k) · Cleared
ClearedCalibrator for Automated Systems (C.F.a.S.) Lipids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rochdiag · JIX Calibrator, Multi-Analyte Mixture
Cleared on Jul 31, 2001 as substantially equivalent to K974825 (Boehringer Mannheim Corp., 1998) after a 63-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Jul 31, 2001
- Review
- 63 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974825 (1998). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK974825 Boehringer Mannheim C.F.a.S. - HDL/LDL-C-PlusBoehringer Mannheim Corp. · 1998
- This deviceK011658 Calibrator for Automated Systems (C.F.a.S.) LipidsRochdiag · 2001
- Descendant · cites it directly · 1 of its ownK040245 Calibrator for Automated Systems Prealbumin-Aslo-Ceruloplasmin…Roche Diagnostics Corp. · 2004
- Descendant · 2 generations on · 0 of its ownK133330 C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2…Roche Diagnostics · 2013
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 |
|---|---|---|---|---|---|
| −1 | K974825 | Boehringer Mannheim C.F.a.S. - HDL/LDL-C-Plus | Boehringer Mannheim Corp. | 1998 | — |
| 0 (this device) | K011658 | Calibrator for Automated Systems (C.F.a.S.) Lipids | Rochdiag | 2001 | — |
| +1 | K040245 | Calibrator for Automated Systems Prealbumin-Aslo-Ceruloplasmin (C.F.a.S. Pac) | Roche Diagnostics Corp. | 2004 | — |
| +2 | K133330 | C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm… | Roche Diagnostics | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 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? (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 |
|---|---|---|---|
| * | K974825 | Boehringer Mannheim C.F.a.S. - HDL/LDL-C-PlusSummary page 2…uivalent to other devices legally marketed in the United States. We claim equivalence to the Roche Diagnostic Calibrator for Automated Systems (C.f.a.s.) HDL/LDL-C plus (K974825). The intended use of both devices is the establishment of calibration curves for their respective test systems. The following t… | 1998 |
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 |
|---|---|---|---|
| K040245 | Calibrator for Automated Systems Prealbumin-Aslo-Ceruloplasmin (C.F.a.S. Pac) | 2004 | 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?
- Its one ancestor has no recall.
- Of its descendants, K040245 (Roche Diagnostics Corp., 2004) has gone furthest, with 1 descendant 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?
For use in the calibration of Roche lipid methods on automated clinical chemistry analyzers.
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/K011658 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011658: Calibrator for Automated Systems (C.F.a.S.) Lipids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011658
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026