510(k) · Cleared
Recalled · Class II · 2018Dimension Vista Ctni Flex Reagent Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · MMI Immunoassay Method, Troponin Subunit
Cleared on Mar 19, 2007 as substantially equivalent to K010313 (Dade Behring, Inc., 2001) after a 90-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 19, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- MMI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010313 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK010313 Dimension Ctni Flex Reagent CartridgeDade Behring, Inc. · 2001 · Recalled
- This deviceK063756 Dimension Vista Ctni Flex Reagent CartridgeDade Behring, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK081643 Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with…Siemens Healthcare Diagnostics · 2008 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K081643Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models, RF621, KD692Siemens Healthcare Diagnostics · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010313 | Dimension Ctni Flex Reagent Cartridge | Dade Behring, Inc. | 2001 | 2 |
| 0 (this device) | K063756 | Dimension Vista Ctni Flex Reagent Cartridge | Dade Behring, Inc. | 2007 | — |
| +1 | K081643 | Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models… | Siemens Healthcare Diagnostics | 2008 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 MMI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MMI device
- #1 K253051 i-STAT hs-TnI cartridge with the i-STAT…score 13.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K010313 | Dimension Ctni Flex Reagent Cartridge | 2001 |
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 |
|---|---|---|---|
| K081643 | Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models, RF621, KD692 | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 2, 2018 | Class II | Z-1671-2018 | Error in labeling | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MMI devicesMMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MMI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MMI
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MMI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MMI
805in 2025
MAUDE reports naming product code MMI, 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 | 3 | 190 | 6 | 352 |
| 2008 | 1 | — | 2 | 837 |
| 2009 | 1 | — | 3 | 1,010 |
| 2010 | 2 | — | 5 | 1,335 |
| 2011 | 1 | — | 1 | 2,406 |
| 2012 | 0 | — | 6 | 1,841 |
| 2013 | 2 | — | 0 | 1,394 |
| 2014 | 0 | — | 1 | 1,150 |
| 2015 | 0 | — | 1 | 831 |
| 2016 | 0 | — | 0 | 487 |
| 2017 | 1 | — | 0 | 618 |
| 2018 | 4 | 344 | 0 | 487 |
| 2019 | 3 | 88 | 1 | 521 |
| 2020 | 0 | — | 1 | 387 |
| 2021 | 1 | — | 1 | 356 |
| 2022 | 1 | — | 0 | 507 |
| 2023 | 3 | 270 | 0 | 748 |
| 2024 | 2 | — | 1 | 921 |
| 2025 | 4 | 266 | 0 | 805 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CTNI method is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in human serum and plasma on the Dimension VistaTM System. Measurements of cardiac troponin I are used to aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063756: Dimension Vista Ctni Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063756
Report an extraction error
Are you the manufacturer?
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