# K081731: Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi Calibrator, Models DF38, DF32

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Aug 29, 2008 after 71 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: 1 generation back to K834502 (1984). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K834502: CK-Nac Reagent, Roche Diagnostic Systems, Inc. (1984) Summary page 1.
- K003158: Roche Diagnostics CK-MB, Roche Diagnostics Corp. (2000) Summary page 1.
- K990460: Calibrator for Automated Systems (C.F.a.S.), Roche Diagnostics Corp. (1999) Summary page 1.

## Most influential descendants
- K083579: Dimension Vista System Enzyme 6 Calibrator, Model KC360 (2009), 1 descendant of its own
- K160724: ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator (2016), 0 descendants of its own
- K083465: Dimension Vista Creatine Kinase Flex Reagent Cartridge and Dimension Vista Creatine Kinase MB Flex Reagent Cartridge (2009), 0 descendants of its own

## Recalls of this device
- Jun 29, 2017 · Class II · Z-1653-2018: 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® clinical chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatmentof 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 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/MBI CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension® clinical chemistry system.

Source page: https://510kreport.com/device/K081731
Methodology: https://510kreport.com/methodology