# K053576: Dimension Vista Myo Reagent Cartridge and Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 7, 2006 after 47 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K984191 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984191: Myoglobin Flex Reagent Cartridge, Dade Behring, Inc. (1998) Summary page 1.
- K984193: Dimensions RXL Myoglobin (Myo) Calibrator, Dade Behring, Inc. (1998) Summary page 1.

## Recalls of this device
- Nov 24, 2014 · Class II · Z-0946-2015: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K053576
Methodology: https://510kreport.com/methodology