510(k) · Cleared
Recalled · Class II · 2014Dimension Vista Myo Reagent Cartridge and Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · JIT Calibrator, Secondary
Cleared on Feb 7, 2006 as substantially equivalent to K984191 (Dade Behring, Inc., 1998) and 1 other predicate after a 47-day review. Its family tree reaches back 1 generation to 1998. It has been recalled once.
- Decided
- Feb 7, 2006
- Review
- 47 days
- Class
- Class II
- Product code
- JIT
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K984191 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK984191 Myoglobin Flex Reagent CartridgeDade Behring, Inc. · 1998
- This deviceK053576 Dimension Vista Myo Reagent Cartridge and CalibratorDade Behring, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984191 | Myoglobin Flex Reagent Cartridge | Dade Behring, Inc. | 1998 | — |
| 0 (this device) | K053576 | Dimension Vista Myo Reagent Cartridge and Calibrator | Dade Behring, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 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? (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 |
|---|---|---|---|
| * | K984191 | Myoglobin Flex Reagent CartridgeSummary page 1…FDA Guidance Documents: Not applicable Predicate Device(s): Dade Behring MYO immunoassay and Calibrator (K984191/K984193) Device Description(s): Method The MYO method is a homogenous sandwich chemiluminescent immunoassay based on Luminescen… | 1998 |
| * | K984193 | Dimensions RXL Myoglobin (Myo) CalibratorSummary page 1…dance Documents: Not applicable Predicate Device(s): Dade Behring MYO immunoassay and Calibrator (K984191/K984193) Device Description(s): Method The MYO method is a homogenous sandwich chemiluminescent immunoassay based on Luminescent Oxygen… | 1998 |
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 |
|---|---|---|---|---|
| Nov 24, 2014 | Class II | Z-0946-2015 | Under Investigation by firm | Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds acceptance criteria for this product. A positive shift observed up to 12% at MYO concentrations within and above… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K984191.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For the quantitative measurement of myoglobin in human serum and plasma on the Dimension VistaTM System as an aid in the rapid diagnosis of acute myocardial infarction.
For the calibration of the myoglobin (MYO) method on the Dimension VistaTM System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053576 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053576: Dimension Vista Myo Reagent Cartridge and Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053576
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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