510(k) · Cleared
ClearedDimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample Diluent
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 Apr 14, 2006 as substantially equivalent to K010313 (Dade Behring, Inc., 2001) and 1 other predicate after a 113-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Apr 14, 2006
- Review
- 113 days
- Class
- Class II
- Product code
- MMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010313 (2001). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010313 Dimension Ctni Flex Reagent CartridgeDade Behring, Inc. · 2001 · Recalled
- This deviceK053577 Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and…Dade Behring, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK081683 Loci Cardiac Troponin I Calibrator, Model RC621Siemens Healthcare Diagnostics · 2008 · Recalled
- 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 2 of 2 · See allView 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) | K053577 | Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample… | Dade Behring, Inc. | 2006 | — |
| +1 | K081683 | Loci Cardiac Troponin I Calibrator, Model RC621 | Siemens Healthcare Diagnostics | 2008 | 3 |
| +1 | K081643 | Dimension Tni Flex Reagent Cartridge, and Ctni Sample Diluent with Models… | Siemens Healthcare Diagnostics | 2008 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 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? (2)
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 CartridgeSummary page 1…Guidance Documents: None applicable Predicate Device(s): Dade Behring CTNI immunoassay and Calibrator (K0103 13/K0103 14) Device Description(s): Method The CTNI method is a one-step sandwich chemiluminescent immunoassay based on Luminescen… | 2001 |
| * | K010314 | Dimension Ctni CalibratorSummary page 1…Documents: None applicable Predicate Device(s): Dade Behring CTNI immunoassay and Calibrator (K0103 13/K0103 14) Device Description(s): Method The CTNI method is a one-step sandwich chemiluminescent immunoassay based on Luminescent Oxygen… | 2001 |
What descends from it? (2)
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 MMI devicesMMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 on the Dimension Vistaim 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.
The CTNI CAL is an in vitro diagnostic product for the calibration of cardiac Troponin-l (CTNI) on the Dimension VistaTM system.
For use on the Dimension Vista TM System to dilute samples with elevated CTNI results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053577 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053577: Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample Diluent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053577
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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