510(k) · Cleared
ClearedSetpoint Chemistry Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · JIX Calibrator, Multi-Analyte Mixture
Cleared on Jan 31, 2003 as substantially equivalent to K990460 (Roche Diagnostics Corp., 1999) after a 14-day review. Its family tree reaches back 1 generation to 1999. 4 later devices descend from it.
- Decided
- Jan 31, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990460 (1999). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK990460 Calibrator for Automated Systems (C.F.a.S.)Roche Diagnostics Corp. · 1999
- This deviceK030169 Setpoint Chemistry CalibratorBayer Healthcare, LLC · 2003
- Descendant · cites it directly · 2 of its ownK031682 Lipoprotein CalibratorBayer Healthcare, LLC · 2003
- Descendant · 2 generations on · 1 of its ownK051619 Lipoprotein for Multiple AnalytesBayer Healthcare, LLC · 2005
- Descendant · 3 generations on · 0 of its ownK061139 Bayer Advia Ims Psa Calibrator and Advia Ims Cpsa CalibratorsBayer Healthcare, LLC · 2006
- Descendant · cites it directly · 0 of its ownK031683 Tox Ammonia CalibratorBayer Healthcare, LLC · 2003 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K031682Lipoprotein CalibratorBayer Healthcare, LLC · 2003 · cites it directly2descendants
- K051619Lipoprotein for Multiple AnalytesBayer Healthcare, LLC · 2005 · 2 generations on1descendant
- K061139Bayer Advia Ims Psa Calibrator and Advia Ims Cpsa CalibratorsBayer Healthcare, LLC · 2006 · 3 generations on0descendants
- K031683Tox Ammonia CalibratorBayer Healthcare, LLC · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990460 | Calibrator for Automated Systems (C.F.a.S.) | Roche Diagnostics Corp. | 1999 | — |
| 0 (this device) | K030169 | Setpoint Chemistry Calibrator | Bayer Healthcare, LLC | 2003 | — |
| +1 | K031682 | Lipoprotein Calibrator | Bayer Healthcare, LLC | 2003 | — |
| +2 | K051619 | Lipoprotein for Multiple Analytes | Bayer Healthcare, LLC | 2005 | — |
| +3 | K061139 | Bayer Advia Ims Psa Calibrator and Advia Ims Cpsa Calibrators | Bayer Healthcare, LLC | 2006 | — |
| +1 | K031683 | Tox Ammonia Calibrator | Bayer Healthcare, LLC | 2003 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K990460 | Calibrator for Automated Systems (C.F.a.S.)Summary page 1…9 115 Hague Rd. Indianapolis, IN 46250 5 1O(k) Number: K990460 4. Device Description The SETpoint Chemistry Calibrator is a bovine serum based solution containing various… | 1999 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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?
Bayer SETpoint Calibrator is intended for in vitro diagnostic use to calibrate the following systems: Technicon RA and opeRA Chemistry Systems, Technicon RA-100, Technicon DAX, ADVIA 1650/ADVIA 2400 Chemistry systems, and ADVIA IMS Chemistry systems.
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/K030169 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030169: Setpoint Chemistry Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030169
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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