510(k) · Cleared
Recalled · Class II · 2016Dimension Vista Chemistry 1 Calibrator, Model KC110
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Aug 21, 2006 as substantially equivalent to K051087 (Dade Behring, Inc., 2005) after a 53-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Aug 21, 2006
- Review
- 53 days
- Class
- Class II
- Product code
- JIX
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922273 (1992). 14 ancestors in all, the oldest K860021 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK922273 Array (R) 360Beckman Instruments, Inc. · 1992
- 2 generations backK990551 Igg Flex Reagent CartridgeDade Behring, Inc. · 1999
- 1 generation backK051087 Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · Recalled
- This deviceK061838 Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK140790 Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista…Siemens Healthcare Diagnostics · 2015 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922273 | Array (R) 360 | Beckman Instruments, Inc. | 1992 | — |
| −2 | K990551 | Igg Flex Reagent Cartridge | Dade Behring, Inc. | 1999 | — |
| −1 | K051087 | Dimension Vista Integrated System | Dade Behring, Inc. | 2005 | 32 |
| 0 (this device) | K061838 | Dimension Vista Chemistry 1 Calibrator, Model KC110 | Dade Behring, Inc. | 2006 | — |
| +1 | K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium… | Siemens Healthcare Diagnostics | 2015 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K051087 | Dimension Vista Integrated SystemSummary page 1…ose, The Dimension Vista TM System Chemistry I Calibrator was previously cleared for the calibration of blood urea nitrogen (BUN) in the Dimension Vista TM System under K05 1087. lactic acid, magnesium, thyroxine, urea nitrogen and uric acid. The kit consists of six vials, three vials of Ca… | 2005 |
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 |
|---|---|---|---|
| K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex… | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 15, 2016 | Class II | Z-0652-2017 | Under Investigation by firm | Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista CHEM 1 CAL lots 5GM081 and 5GM082. |
| Aug 18, 2014 | Class II | Z-2720-2014 | Process design | Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, lot 3GM081. Investigation by Siemens… |
| Aug 31, 2009 | Not classified | Z-0864-2010 | Other | Siemens Healthcare Diagnostics, Inc. has confirmed high accuracy shifts with Dimension Vista URCA Flex reagent cartridge (various lots) when calibrating with some vials from CHEM 1 calibrator lot 9DM001. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- 5 of the 14 ancestors have a recall of any class.
- Of its descendants, K140790 (Siemens Healthcare Diagnostics, 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K051087.
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?
The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (URCA) methods on the Dimension VistaT M System
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/K061838 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061838: Dimension Vista Chemistry 1 Calibrator, Model KC110.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061838
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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