# K062128: The Dimension Vista Flex Reagent Cartridges / Kit Assays - Pathway: 510(k) (Special) - Applicant: Dade Behring, Inc. - Decided: Aug 21, 2006 after 26 days - Product code: JHS (Differential Rate Kinetic 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 Longest line of descent: 4 generations back to K010496 (2001). 20 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 22 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K943024: Kinase Isoenzyme, Dupont Medical Products (1994) Summary page 2. - K011852: Dimension Haic Assay, Model DF105, Dade Behring, Inc. (2001) Summary page 2. - K040133: Urine Amphetamine/Methamphetamine Screen Flex Reagent Cartridge, Dade Behring, Inc. (2004) Summary page 2. - K000459: Urine Barbiturates (Barb) Screen Flex Reagent Cartridge, Catalog NO. DF 96A, Dade Behring, Inc. (2000) Summary page 2. - K000458: Urine Benzodiazepines (Benz) Screen Flex Reagent Cartridge, Catalog NO. DF 92A, Dade Behring, Inc. (2000) Summary page 2. - K033713: Urine Cocaine Metabolite Screen Flex Reagent Cartridge, Catalog# DF92A, Dade Behring, Inc. (2004) Summary page 2. - K053337: Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model DF 109, Dade Behring, Inc. (2006) Summary page 2. - K000466: Urine Methadone (Meth) Screen Flex Reagent Cartridge, Catalog NO. DF 93A, Dade Behring, Inc. (2000) Summary page 2. - K003209: Urine Opiates (Opi) Screen Flex Reagent Cartridge, Catalog NO. DF93A, Dade Behring, Inc. (2000) Summary page 2. - K000462: Urine Phencyclidine (PCP) Screen Flex Reagent Cartridge, Catalog NO. DF 94A, Dade Behring, Inc. (2000) Summary page 2. - K000461: Urine Cannabinoids (THC) Screen Flex Reagent Cartridge, Catalog NO. DF 95A, Dade Behring, Inc. (2000) Summary page 2. ## Most influential descendants - K102045: Dimension Visa HBA1C, Model K3105A (2011), 0 descendants of its own ## Indications for use The Dimension VistaTM Creatine Kinase MB Isoenzyme (CKMB) Flex® reagent cartridge is a device intended to measure the activity of the creatine kinase MB isoenzyme in plasma and serum. Measurements of creatine kinase MB isoenzyme are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The HAIC assay used on the Dimension Vista rMintegrated system is an in-vitro diagnostic assay for the quantitative determination of percent hemoglobin A I c(HbA l c) in anticoagulated whole blood. Measurements of percent hemoglobin Alc are effective in monitoring long term glucose control in individuals with diabetes mellitus. The AMPH Flex® reagent cartridge used on the Dimension VistaTM integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of amphetamines in human urine using a cutoff of either 300, 500, or 1000 ng/mL. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose. The AMPH method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The BARB Flex®reagent cartridge used on the Dimension VistaTM integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of barbiturates in human urine. Measurements obtained with the BARB method are used in the diagnosis and treatment of barbiturates use or overdose. The BARB method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The BENZ Flex® reagent cartridge used on the Dimension VistaTM integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of benzodiazepines in human urine. Measurements obtained with the BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose. The BENZ method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The COC Flex® reagent cartridge used on the Dimension VistaTM integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semti-quantitative determination of benzoylecgonine (cocaine metabolite) in human urine using a cutoff of 150 or 300 ng/mL. Measurements obtained with the COG method are used in the diagnosis and treatment of cocaine use or overdose. The COC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The EXTC Flex® reagent cartridge used on the Dimension VistaTM integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of methylenedioxymethamphetamine (MDMA), and closely related drugs in human urine using a cutoff of either 300 or 500 ng/mL. Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose. The EXTC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The METH Flex® reagent cartridge used on the Dimension VistaTM integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of methadone in human urine. Measurements obtained with the METH method are used to detect methadone use or overdose and to determine compliance with methadone maintenance treatment. The METH method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The OPI Flex® reagent cartridge (300 ng/mL cutoff) used on the Dimension Vista rM integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of opiates in human urine. Measurements obtained with the OPI method are used in the diagnosis and treatment of opiates use or overdose. The OPI method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The PCP Flex® reagent cartridge used on the Dimension VistaTm integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of phencyclidine in human urine. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose. The PCP method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The THC Flex® reagent cartridge used on the Dimension VistaTm integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of cannabinoids in human urine. Measurements obtained with the THC method are used in the diagnosis and treatment of cannabinoids use or overdose. The TIHC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. Source page: https://510kreport.com/device/K062128 Methodology: https://510kreport.com/methodology