(95 days)
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® 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.
Dimension Vista® (CKI) Flex® Reagent Cartridge (K2038): In a coupled enzyme reaction, the creatine kinase in patient samples catalyzes the transphosphorylation of phosphate from creatine phosphate to adenosine-diphosphate (ADP) producing adenosine-triphosphate (ATP). Hexokinase (HK) phosphorylates glucose from the ATP to phosphorylate glucose. The resulting glucose-6-phosphate is oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP). The rate of formation of NADPH is directly proportional to the CK activity in the sample and is measured bichromatically at 340 and 540 nm.
Dimension Vista® (MBI) Flex® Reagent Cartridge (K2032): The activity of the CK-MM isoenzyme is inhibited by an antibody specific for the CK-M subunit. The activity of the B subunit of creatine kinase MB isoenzyme is not inhibited, and it is on this basis that CK-MB can be measured. In an enzyme coupled reaction, creatine kinase in patient samples catalyzes the transphosphorylation of creatine phosphate to adenosine-diphosphate (ADP), producing adenosine-triphosphate (ATP). Hexokinase (HK) uses the ATP to phosphorylate glucose. The resulting glucose-6-phosphate is oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP) to NADPH. The rate of formation of NADPH is measured bichromatically at 340, 540 nm and is directly proportional to CK-B activity in the sample.
This document describes the 510(k) summary for the Dimension Vista® Creatine Kinase Flex® and Creatine Kinase MB Flex® Reagent Cartridges (K2038 and K2032, respectively).
Here's an analysis of the provided text to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document establishes substantial equivalence by comparing the performance characteristics of the new Dimension Vista® cartridges with their predicate devices, Dimension® CKI (DF38) and MBI (DF32) Flex® Reagent Cartridges (K081731). The acceptance criteria are implicitly defined by the performance of the predicate device, and the new devices are deemed to "demonstrate substantial equivalent performance."
| Feature | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Dimension Vista®) |
|---|---|---|
| CKI Reagent (K2038) | ||
| Intended Use | Quantitative measurement of creatine kinase in human serum and plasma on the Dimension® Clinical Chemistry System. | Quantitative measurement of creatine kinase in human serum and plasma on the Dimension Vista® Clinical Chemistry System. |
| Device Technology (detection) | Bichromatic rate | Bichromatic rate |
| Measuring Range | 7 - 1000 U/L | 7 - 1000 U/L |
| Limit of Detection | 7 U/L | 7 U/L |
| MBI Reagent (K2032) | ||
| Intended Use | Quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension® clinical chemistry system. | Quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension Vista® clinical chemistry system. |
| Device Technology (detection) | Bichromatic rate | Bichromatic rate |
| Measuring Range | 3 - 125 U/L | 3 - 125 U/L |
| Analytical Sensitivity | 3 U/L | 3 U/L |
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 substantial equivalent performance." However, it does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective).
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. For in vitro diagnostic tests like these, "ground truth" is typically established by reference methods or validated laboratory results, not by human expert interpretation of images or other subjective data.
4. Adjudication method for the test set:
This information is not applicable as the "test set" in this context refers to clinical samples analyzed by the device, not data requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable as the device is a reagent cartridge for an in vitro diagnostic assay, not an AI-powered diagnostic imaging tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is inherently a "standalone" system in the sense that it performs the measurement algorithmically without a human actively interpreting its real-time output for a diagnostic decision in the same way an AI for image analysis would. The device generates quantitative results, which are then used by clinicians for diagnosis and treatment. Therefore, the performance presented is standalone performance of the reagent cartridges on the Dimension Vista® system.
7. The type of ground truth used:
The "ground truth" for evaluating these reagent cartridges would typically be established by:
- Reference methods: Highly accurate and precise laboratory methods for measuring Creatine Kinase (CK) and Creatine Kinase MB (CK-MB).
- Validated laboratory results: Measurements obtained using existing, cleared devices that are considered reliable standards.
The document implicitly refers to this by stating "comparative testing" with the predicate devices, meaning the predicate device results served as the reference for determining substantial equivalence.
8. The sample size for the training set:
This information is not provided in the document. For in vitro diagnostic reagents, there isn't a "training set" in the machine learning sense. The "development" or "optimization" phase would involve testing various formulations and conditions, but this is not typically referred to as a "training set" with explicit sample sizes in the regulatory submission summary for such devices.
9. How the ground truth for the training set was established:
This information is not provided and is generally not applicable in the context of traditional in vitro diagnostic reagent development in the same way it would be for an AI algorithm. The "ground truth" would be established by the rigorous chemical and enzymatic principles underlying the assay and validated against known standards and reference materials during the development and manufacturing process.
§ 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.