510(k) · Cleared
ClearedCalibrator for Automated Systems (C.F.a.S.)
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 Mar 22, 1999 after a 38-day review. The FDA summary names its predicate without a number. 43 later devices descend from it.
- Decided
- Mar 22, 1999
- Review
- 38 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 0
43 later devices descend from it, 5 citing it directly.
- This deviceK990460 Calibrator for Automated Systems (C.F.a.S.)Roche Diagnostics Corp. · 1999
- Descendant · cites it directly · 31 of its ownK033501 Modification to Calibrator for Automatic Systems (Cfas)Roche Diagnostics Corp. · 2003
- Descendant · 2 generations on · 15 of its ownK052007 Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005 · Recalled
- Descendant · cites it directly · 4 of its ownK030169 Setpoint Chemistry CalibratorBayer Healthcare, LLC · 2003
- Descendant · cites it directly · 3 of its ownK081731 Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent…Siemens Healthcare Diagnostics · 2008 · Recalled
- Descendant · 3 generations on · 3 of its ownK060854 Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · Recalled
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K033501Modification to Calibrator for Automatic Systems (Cfas)Roche Diagnostics Corp. · 2003 · cites it directly31descendants
- K052007Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)Horiba Abx · 2005 · 2 generations on15descendants
- K030169Setpoint Chemistry CalibratorBayer Healthcare, LLC · 2003 · cites it directly4descendants
- K081731Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi…Siemens Healthcare Diagnostics · 2008 · cites it directly3descendants
- K060854Abx Pentra 400: LipoproteinsHoriba Abx · 2006 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) | Horiba Abx | 2005 | 6 |
| +1 | K030169 | Setpoint Chemistry Calibrator | Bayer Healthcare, LLC | 2003 | — |
| +1 | K081731 | Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge… | Siemens Healthcare Diagnostics | 2008 | 1 |
| +3 | K060854 | Abx Pentra 400: Lipoproteins | Horiba Abx | 2006 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 10 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | — | Roche Serum Calibrator Named without a submission number |
What descends from it? (43)
See all 435 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033501 | Modification to Calibrator for Automatic Systems (Cfas) | 2003 | 31 |
| K030169 | Setpoint Chemistry Calibrator | 2003 | 4 |
| K081731 | Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi… | 2008 | 3 |
| K080485 | Aspartate Amino Transferase (Ast/Sgot) Test System, Asat (Got) FS | 2008 | 0 |
| K033643 | CO2 Calibrator/Diluent | 2004 | 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?
- Of its descendants, K033501 (Roche Diagnostics Corp., 2003) has gone furthest, with 31 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?
For use as a calibrator of clinical chemistry assays. Biological materials are added as required to obtain desired component levels. This calibrator material is well suited for automated analytical procedures. Levels of constituent analytes are provided in product labeling.
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/K990460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990460: Calibrator for Automated Systems (C.F.a.S.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990460
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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