510(k) · Cleared
Recalled · Class III · 2016Dimension Visa Enz 2 Cal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Jan 25, 2011 as substantially equivalent to K061390 (Dade Behring, Inc., 2006) after a 47-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 25, 2011
- Review
- 47 days
- Class
- Class II
- Product code
- JIX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K860021 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK860021 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986 · Recalled
- 1 generation backK061390 Dimension Vista System ENZYME2 Calibrator, Model KC320Dade Behring, Inc. · 2006
- This deviceK103612 Dimension Visa Enz 2 CalSiemens Healthcare Diagnostics, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK153365 ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2…Siemens Healthcare Diagnostics, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K153365ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 CalibratorSiemens Healthcare Diagnostics, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K860021 | Dimension (TM) Clinical Chemistry System | E.I. Dupont DE Nemours & Co., Inc. | 1986 | 1 |
| −1 | K061390 | Dimension Vista System ENZYME2 Calibrator, Model KC320 | Dade Behring, Inc. | 2006 | — |
| 0 (this device) | K103612 | Dimension Visa Enz 2 Cal | Siemens Healthcare Diagnostics, Inc. | 2011 | — |
| +1 | K153365 | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator | Siemens Healthcare Diagnostics, Inc. | 2015 | — |
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 |
|---|---|---|---|
| * | K061390 | Dimension Vista System ENZYME2 Calibrator, Model KC320Summary page 1…X; Panel: Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: Dimension Vista® ENZ 2 CAL (KC320) k061390 4. Device Descriptions: ENZ 2 CAL is a liquid, multi-analyte, bovine serum albumin based product containing… | 2006 |
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 |
|---|---|---|---|
| K153365 | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 5, 2016 | Class III | Z-1216-2017 | Under Investigation by firm | Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 20.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K153365 (Siemens Healthcare Diagnostics, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K061390.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 ENZ 2 CAL is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALT and ALTI) and Aspartate Aminotransferase (AST) on the Dimension Vista® System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103612: Dimension Visa Enz 2 Cal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103612
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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