510(k) · Cleared
Recalled · Class III · 2017Enzyme II Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JIT Calibrator, Secondary
Cleared on Feb 16, 2011 as substantially equivalent to K061390 (Dade Behring, Inc., 2006) after a 48-day review. Its family tree reaches back 2 generations to 1986. It has been recalled 2 times.
- Decided
- Feb 16, 2011
- Review
- 48 days
- Class
- Class II
- Product code
- JIT
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K860021 (1986). No later device cites it as a predicate yet.
- 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 deviceK103836 Enzyme II CalibratorSiemens Healthcare Diagnostics, Inc. · 2011
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) | K103836 | Enzyme II Calibrator | Siemens Healthcare Diagnostics, Inc. | 2011 | — |
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 JIT? 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…JIX; Panel: Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: Dimension Vista® ENZ 2 CAL k061390 4. Device Descriptions: ENZ 11 CAL is a liquid, multi-analyte, bovine serum albumin based product contain… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 23, 2017 | Class III | Z-1712-2017 | Under Investigation by firm | Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concentrated (AST_c) assays following calibration with… |
| May 5, 2016 | Class III | Z-1217-2017 | Under Investigation by firm | Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10%… |
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.
- 1 other device also cites its predicate K061390.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Enzyme 11Calibrator is an in vitro diagnostic product for the calibration of Alanine
Aminotransferase (ALTI) on the Dimension® clinical chemistry system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103836: Enzyme II Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103836
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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