510(k) · Cleared
ClearedCalibrator for Automated Systems (C.F.a.S.), Model 10759350 360
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Sep 13, 2006 as substantially equivalent to K033501 (Roche Diagnostics Corp., 2003) after a 35-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Sep 13, 2006
- Review
- 35 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K990460 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK990460 Calibrator for Automated Systems (C.F.a.S.)Roche Diagnostics Corp. · 1999
- 1 generation backK033501 Modification to Calibrator for Automatic Systems (Cfas)Roche Diagnostics Corp. · 2003
- This deviceK062319 Calibrator for Automated Systems (C.F.a.S.), Model 10759350 360Roche Diagnostics Corp. · 2006
- Descendant · cites it directly · 0 of its ownK101456 Roche Diagnostics Calibrator for Automated Systems, Roche…Roche Diagnostics · 2010
Most influential descendants
Showing 1 of 1 · See all- K101456Roche Diagnostics Calibrator for Automated Systems, Roche Diagnostics Calibrator…Roche Diagnostics · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990460 | Calibrator for Automated Systems (C.F.a.S.) | Roche Diagnostics Corp. | 1999 | — |
| −1 | K033501 | Modification to Calibrator for Automatic Systems (Cfas) | Roche Diagnostics Corp. | 2003 | — |
| 0 (this device) | K062319 | Calibrator for Automated Systems (C.F.a.S.), Model 10759350 360 | Roche Diagnostics Corp. | 2006 | — |
| +1 | K101456 | Roche Diagnostics Calibrator for Automated Systems, Roche Diagnostics… | Roche Diagnostics | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K033501 | Modification to Calibrator for Automatic Systems (Cfas)Summary page 1…fications to our Calibrator for Automated Systems (C.fa.s.). This calibrator was originally cleared for use as K990460 and modified via K033501. Modifications to the calibrator include: • Modification to reagent composition: addition of… | 2003 |
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 |
|---|---|---|---|
| K101456 | Roche Diagnostics Calibrator for Automated Systems, Roche Diagnostics Calibrator… | 2010 | 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 7 years and passes through 1 company; a new generation was cleared every 4.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K101456 (Roche Diagnostics, 2010) has gone furthest, with 0 descendants of its own.
- 16 other devices also cite its predicate K033501.
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?
Calibrator for automated systems (C.f as.) 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/K062319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062319: Calibrator for Automated Systems (C.F.a.S.), Model 10759350 360.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062319
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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