510(k) · Cleared
ClearedRoche Diagnostics Calibrator for Automated Systems, Roche Diagnostics Calibrator Calibrator for Automated System
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 Sep 8, 2010 as substantially equivalent to K062319 (Roche Diagnostics Corp., 2006) and 1 other predicate after a 105-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Sep 8, 2010
- Review
- 105 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K990460 (1999). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK990460 Calibrator for Automated Systems (C.F.a.S.)Roche Diagnostics Corp. · 1999
- 2 generations backK033501 Modification to Calibrator for Automatic Systems (Cfas)Roche Diagnostics Corp. · 2003
- 1 generation backK062319 Calibrator for Automated Systems (C.F.a.S.), Model 10759350 360Roche Diagnostics Corp. · 2006
- This deviceK101456 Roche Diagnostics Calibrator for Automated Systems, Roche…Roche Diagnostics · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990460 | Calibrator for Automated Systems (C.F.a.S.) | Roche Diagnostics Corp. | 1999 | — |
| −2 | K033501 | Modification to Calibrator for Automatic Systems (Cfas) | Roche Diagnostics Corp. | 2003 | — |
| −1 | K062319 | Calibrator for Automated Systems (C.F.a.S.), Model 10759350 360 | Roche Diagnostics Corp. | 2006 | — |
| 0 (this device) | K101456 | Roche Diagnostics Calibrator for Automated Systems, Roche Diagnostics… | Roche Diagnostics | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K062319 | Calibrator for Automated Systems (C.F.a.S.), Model 10759350 360Summary page 1…(O~fa~s.) and C~fa~s. CK-MB. 1. C~fa.s. was originally cleared for use in K990460, then modified in K033501 and K0623 19. 2. COfa~s. CK-MB was originally cleared for use in K003 158. Modifications to these device… | 2006 |
| * | K003158 | Roche Diagnostics CK-MBSummary page 1…iginally cleared for use in K990460, then modified in K033501 and K0623 19. 2. COfa~s. CK-MB was originally cleared for use in K003 158. Modifications to these devices include changing common source materials for three analytes… | 2000 |
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 11 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 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. 2010, 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?
Calibrator for automated systems (C.fa.s) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
C.fa.s. (Calibrator for automated systems) CK-MB is for use in the calibration of Roche methods for the quantitative determination of CK-MB on Roche clinical chemistry analyzers as specified in the value sheets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101456: Roche Diagnostics Calibrator for Automated Systems, Roche Diagnostics Calibrator Calibrator for Automated System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101456
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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