(330 days)
Randox Liquid CK-MB: The Randox Liquid CK-MB test system is a device intended for the quantitative in vitro determination of CK-MB concentration in serum and plasma. Measurements of CK-MB are used in the diagnosis and treatment of myocardial infarction (MI). This product is suitable for use on the RX series instruments including the RX Daytona and the RX Imola.
Randox CK-MB Calibrator: The Randox CK-MB calibrator is an in vitro diagnostic product intended for use in the calibration of Randox CK-MB methods.
The Randox Liquid CK-MB test system for the RX Imola is a prescription use device intended to be used in clinical laboratories only.
Liquid CK-MB is supplied in a kit containing:
- 4 x 20.0 mL CK-MB Buffer
- 4 x 6.0 mL CK-MB Substrate.
The CK-MB calibrator is lyophilised, single analyte, human serum based product. The kit contains ten vials (single level) with 1.0 mL per vial. Double de-ionised water is required for reconstitution.
Here's a summary of the acceptance criteria and the study details for the Randox Liquid CK-MB and Randox CK-MB Calibrator, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document outlines performance characteristics rather than explicit "acceptance criteria" in a pass/fail table. However, implied acceptance is demonstrated by the reported empirical results.
| Performance Characteristic | Acceptance Criteria (Implied by Study Design) | Reported Device Performance (RX Daytona) | Reported Device Performance (RX Imola) |
|---|---|---|---|
| Precision (Total CV%) | No explicit criteria given, but results are expected to be low and consistent. | 10.9% (at 9.90 U/L), 2.9% (at 1011.98 U/L), 2.5% (at 244.85 U/L), 2.8% (at 437.45 U/L), 3.3% (at 47.53 U/L), 2.5% (Calibrator), 3.2% (Control) | 12.5% (at 10.38 U/L), 4.0% (at 1001.29 U/L), 3.4% (at 245.62 U/L), 3.3% (at 437.83 U/L), 5.0% (at 47.43 U/L), 3.3% (Calibrator), 2.8% (Control) |
| Linearity/Reportable Range | Deviation from linearity less than 5% within the claimed range. | 7 - 2000 U/L | 6 - 1100 U/L |
| Extended Recovery | ± 10% | 10200 U/L ± 10% | 10200 U/L ± 10% |
| Limit of Detection (LoD) | Not explicitly stated, but lower values indicate better sensitivity. | 5.06 U/L | 2.41 U/L |
| Limit of Blank (LoB) | Not explicitly stated, but lower values indicate better sensitivity. | 2.91 U/L | 0.87 U/L |
| Limit of Quantitation (LoQ) | ≤20% accuracy and ≤20% imprecision. | 7.00 U/L | 6.00 U/L |
| Analytical Specificity (Interference) | % of Control ± 10% | Met for all tested interferents (except Intralipid*) | Met for all tested interferents (except Intralipid*) |
| Method Comparison (Correlation with Predicate) | High correlation (strong linear relationship) | r = 0.999 (Y = 0.95 + 0.59) | r = 0.999 (Y = 0.96 + 2.36) |
| Matrix Comparison (Correlation with Serum) | High correlation (strong linear relationship) | r = 1.000 (Lithium Heparin), r = 0.999 (Potassium EDTA) | r = 0.999 (Lithium Heparin), r = 1.000 (Potassium EDTA) |
| Expected Values/Reference Range | All values reported in the expected range for Healthy Individuals ( |
§ 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.