# K970343: MMB Method

- Pathway: 510(k) (Traditional)
- Applicant: Dade Chemistry Systems, Inc.
- Decided: Feb 14, 1997 after 16 days
- Product code: JHY (Colorimetric Method, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 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) Abbott Laboratories IMx® Stat CK-MB: named in the summary without a submission number

## Most influential descendants
- K051087: Dimension Vista Integrated System (2005), 5 descendants of its own
- K073561: Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator (2008), 1 descendant of its own
- K061838: Dimension Vista Chemistry 1 Calibrator, Model KC110 (2006), 1 descendant of its own
- K143720: Dimension Vista MMB Assay (2015), 0 descendants of its own
- K140790: Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) (2015), 0 descendants of its own

## Indications for use
The MMB Method for the Dimension® RxL Clinical Chemistry System with the heterogeneous immunoassay module is used to quantitatively measure CKMB in human serum and plasma.

Source page: https://510kreport.com/device/K970343
Methodology: https://510kreport.com/methodology