(67 days)
For in vitro diagnostic use with the CARESIDE Analyzer™ to quantitatively measure CK from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
CARESIDE™ CK cartridges are used with the CARESIDE, Inc. CARESIDE Analyzer™ to measure CK activity in whole blood, serum or plasma specimens. The CARESIDE™ CK cartridge, a single use disposable in vitro diagnostic test cartridge, delivers a measured volume of serum or plasma to a dry film to initiate the measurement of CK activity. The film cartidge (patent pending) contains all reagents necessary to measure CK activity.
Here is a summary of the acceptance criteria and the study details for the CARESIDE™ CK device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | CARESIDE™ CK Performance |
|---|---|
| Detection limit | 20 U/L |
| Reportable range | 20 to 1600 U/L |
| Accuracy | Mean recovery 101% |
| Precision | Total CV, 168 U/L, 10% |
| Linearity | Linearity yielded slope and correlation coefficient within acceptable limits. |
| Interference | No significant interference observed at tested concentrations of interferent: Ascorbic Acid, 10 mg/dL; Bilirubin, 20 mg/dL; Triglycerides 2000 mg/dL |
Note: The provided document does not explicitly state pre-defined "acceptance criteria" against which these performance metrics were tested, but rather reports the device's performance. The conclusion states that the data demonstrates the device "performs as well as or better than the legally marketed predicate device," implying these results met the necessary thresholds for substantial equivalence to the predicate (Vitros CK DT Slides). The predicate device's specific values for Accuracy, Linearity, and Reference Method are not provided for direct comparison, but the detection limit and reportable range are identical.
Study Details
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Sample sizes used for the test set and the data provenance:
- The document does not specify the sample size used for the test set (e.g., for accuracy, precision, linearity, or interference studies).
- The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts or their qualifications for establishing ground truth in the context of the device's performance evaluation. The reference method used for comparison is a "Kinetic determination with enzymatically coupled spectrophotometric detection of creatine." This suggests a laboratory-based method of higher accuracy was used as the ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method is described. The performance is reported against a "Reference Method."
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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 a diagnostic device for measuring Creatine Kinase (CK) activity, not an AI-assisted imaging or diagnostic tool that involves "human readers." Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance in that context is not applicable and was not performed.
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If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Yes, the performance characteristics (detection limit, reportable range, accuracy, precision, linearity, interference) are reported for the CARESIDE™ CK device as a standalone analytical instrument. This device is an in vitro diagnostic test system; its performance metrics describe the algorithm/device's ability to measure CK activity independently.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for accuracy and method comparison was established using a "Reference Method: Kinetic determination with enzymatically coupled spectrophotometric detection of creatine." This is a laboratory-based analytical method considered highly accurate for CK measurement.
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The sample size for the training set:
- The document does not mention a "training set" in the context of device development. This device is a chemical assay system, not a machine learning model that typically requires a separate training set. Its calibration is mentioned as "bar-coded on each cartridge" and "may change with each lot," indicating a manufacturer-defined calibration rather than a trained algorithm.
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How the ground truth for the training set was established:
- As no "training set" is described for this type of device, this question is not applicable. The device relies on a pre-defined chemical reaction and established spectrophotometric principles for its measurement and calibration.
§ 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.