(26 days)
The Dimension Vista™ Creatine Kinase MB Isoenzyme (CKMB) Flex® reagent cartridge is a device intended to measurement the activity of the creatine kinase MB isoenzyme in plasma and serum. Measurements with 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™ integrated system is an in-vitro diagnostic assay for the quantitative determination of percent hemoglobin A1c(HbA1c) in anticoagulated whole blood. Measurements of percent hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.
The AMPH Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative 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 Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative 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 Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative 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 Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of benzoylecgonine (cocaine metabolite) in human urine using a cutoff of 150 or 300 ng/mL. Measurements obtained with the COC 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 Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of methylenedioxymethamine (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 Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative 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™ 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 Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative 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 Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative 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 THC 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.
Dade Behring Dimension Vista™ Flex® reagent cartridges and the HA1C kit are prepackaged Dade Behring products that are specifically designed to be used on the Dade Behring Dimension Vista™ integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system. The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The calibrator included in the Dimension Vista™ HAIC kit is the same product (unchanged) as that used in the Dimension® HA1C Kit. The packaging modification, does not affect the intended use of the devices. nor does it alter the fundamental scientific technology of the devices.
Please find the requested information regarding the acceptance criteria and study details below.
1. Table of Acceptance Criteria and the Reported Device Performance
The provided document describes a 510(k) submission for new reagent cartridges and a kit for the Dimension Vista™ system, which are essentially packaging modifications of existing, previously cleared devices for use on a new analyzer system. The core scientific technology and reagents remain the same.
The document mainly focuses on demonstrating substantial equivalence to predicate devices rather than establishing new performance criteria. Therefore, the "acceptance criteria" are implied to be performance comparable to the predicate devices, and the "reported device performance" is framed in terms of achieving this equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reagents are identical to predicate devices. | "The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems..." |
| Calibrator for HA1C is identical to predicate device. | "The calibrator included in the Dimension Vista™ HA1C kit is the same product (unchanged) as that used in the Dimension® HA1C Kit." |
| Packaging modification does not affect intended use. | "The packaging modification, does not affect the intended use of the devices." |
| Packaging modification does not alter fundamental scientific technology. | "nor does it alter the fundamental scientific technology of the devices." |
| Performance is substantially equivalent to predicate devices. | "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance." |
| "The Flex® reagent cartridges/kit... are substantially equivalent in all aspects... for same intended use and indications for use." | "Comparative testing also demonstrates substantially equivalent performance." |
2. Sample Size Used for the Test Set and the Data Provenance
The document states, "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for these comparative tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. As this is an in-vitro diagnostic device for quantitative and qualitative measurements, the "ground truth" would likely be established through reference methods (e.g., GC/MS for drug screens, or an established method for CKMB and HbA1c) rather than expert consensus on images or clinical cases.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided in the document. Given the nature of these in-vitro diagnostic tests, adjudication methods like 2+1 or 3+1, which are common in image interpretation or clinical expert review, are not applicable. Instead, the performance would be compared against a reference method or predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
No MRMC comparative effectiveness study was done, nor is it applicable to this submission. The device involves in-vitro diagnostic reagent cartridges for automated analyzer systems, not an AI-assisted interpretation or diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, this describes a standalone performance evaluation in the context of an in-vitro diagnostic device. The Dimension Vista™ system is described as a "floor model, fully automated, microprocessor-controlled, integrated instrument system." The reagents are designed for use on this automated system. The comparative testing would confirm the analytical performance of the reagents on the new system, without human interpretation of the raw data beyond standard laboratory procedures.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the drug screens (Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Ecstasy, Methadone, Opiates, Phencyclidine, Cannabinoids), the "Indications For Use" sections explicitly state: "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." This indicates that GC/MS is the ground truth or gold standard against which the screening tests are compared.
For Creatine Kinase MB Isoenzyme (CKMB) and Hemoglobin A1c (HA1C), while not explicitly stated as GC/MS, the "ground truth" would be established by comparison to accepted reference methods or the performance of the predicate devices themselves, as the submission aims to demonstrate substantial equivalence to these existing methods.
8. The Sample Size for the Training Set
The document is a 510(k) submission for modifications to existing products for use on a new instrument system. It focuses on comparative testing to establish substantial equivalence. It does not describe a "training set" in the context of machine learning or algorithm development. The reagents and their fundamental scientific technology are stated to be unchanged from previously cleared devices.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there is no mention of a "training set" in the context of algorithm development or machine learning in this document. The device's underlying technology is based on established biochemical assays, not a learnable algorithm requiring a training set.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. 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.(b)
Classification. Class II.