# K984191: Myoglobin Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Dec 10, 1998 after 17 days
- Product code: DDR (Myoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stratus® Myoglogobin Fluorometric Enzyme Immunoassay: named in the summary without a submission number

## Most influential descendants
- K053576: Dimension Vista Myo Reagent Cartridge and Calibrator (2006), 0 descendants of its own
- K033300: Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range Verifiers (2003), 0 descendants of its own

## Indications for use
The MYO method for the Dimension® RxL with the heterogeneous immunoassay module is a device used to quantitatively measure myoglobin in human serum and plasma as an aid in the rapid diagnosis of acute myocardial infarction.

Source page: https://510kreport.com/device/K984191
Methodology: https://510kreport.com/methodology