# K083465: Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista Creatine Kinase MB Flex Reagent Cartridge

- Pathway: 510(k) (Special)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Feb 27, 2009 after 95 days
- Product code: CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- 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: 2 generations back to K834502 (1984). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081731: Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi Calibrator, Models DF38, DF32, Siemens Healthcare Diagnostics (2008) Summary page 1.

## Recalls of this device
- Jun 29, 2017 · Class II · Z-1659-2018: Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely dep

## Indications for use
The creatine kinase MB (MBI) method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension Vista ® clinical chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The CKI method is an in vitro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension Vista ® clinical chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Source page: https://510kreport.com/device/K083465
Methodology: https://510kreport.com/methodology