510(k) · Cleared
ClearedDimension Vista System ENZYME2 Calibrator, Model KC320
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 Jul 5, 2006 as substantially equivalent to K860021 (E.I. Dupont DE Nemours & Co., Inc., 1986) after a 48-day review. Its family tree reaches back 1 generation to 1986. 3 later devices descend from it.
- Decided
- Jul 5, 2006
- Review
- 48 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K860021 (1986). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK860021 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986 · Recalled
- This deviceK061390 Dimension Vista System ENZYME2 Calibrator, Model KC320Dade Behring, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK103612 Dimension Visa Enz 2 CalSiemens Healthcare Diagnostics, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK153365 ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2…Siemens Healthcare Diagnostics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK103836 Enzyme II CalibratorSiemens Healthcare Diagnostics, Inc. · 2011 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K103612Dimension Visa Enz 2 CalSiemens Healthcare Diagnostics, Inc. · 2011 · cites it directly1descendant
- K153365ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 CalibratorSiemens Healthcare Diagnostics, Inc. · 2015 · 2 generations on0descendants
- K103836Enzyme II CalibratorSiemens Healthcare Diagnostics, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860021 | Dimension (TM) Clinical Chemistry System | E.I. Dupont DE Nemours & Co., Inc. | 1986 | 1 |
| 0 (this device) | K061390 | Dimension Vista System ENZYME2 Calibrator, Model KC320 | Dade Behring, Inc. | 2006 | — |
| +1 | K103612 | Dimension Visa Enz 2 Cal | Siemens Healthcare Diagnostics, Inc. | 2011 | 1 |
| +2 | K153365 | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
| +1 | K103836 | Enzyme II Calibrator | Siemens Healthcare Diagnostics, Inc. | 2011 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K860021 | Dimension (TM) Clinical Chemistry SystemSummary page 2…e-vdlume pervial is 1.5 mL. I. Substantial Equivalence Information: 1. Predicate Device: Dimension® Enzyme Verifier (DC19). 2. Predicate K Number: K860021 for Dimension® clinical chemistry system. 3. Comparison with Predicate: Item Dimension Vista TM… | 1986 |
What descends from it? (3)
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?
The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) on the Dimension VistaTM System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061390 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061390: Dimension Vista System ENZYME2 Calibrator, Model KC320.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061390
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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