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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.

Device Description

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.

AI/ML Overview

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 (<25U/L).	All values within <25U/L	All values within <25U/L

Note: Intralipid interfered, and the recommendation is to use clear, non-lipemic serum and plasma.

2. Sample Size and Data Provenance for Test Set

Precision/Reproducibility:
- Human Serum Samples (Spiked): 5 levels (10U/L, 50U/L, 250U/L, 450U/L, and 1100U/L).
- Calibrator and Control Material: 1 level each.
- Testing Protocol: 20 or 21 non-consecutive days, twice per day, 2 replicates per run. This totals 80-84 measurements per sample type.
- Data Provenance: Not explicitly stated, but "unaltered human serum samples" and "control material" are mentioned. The origin (country, retrospective/prospective) is not provided.
Linearity/Assay Reportable Range:
- Samples prepared at 11 levels.
- Data Provenance: Not explicitly stated.
Detection Limit:
- 300 determinations with 1 blank and 4 low-level samples for LoD.
- Data Provenance: Not explicitly stated.
Analytical Specificity:
- Two serum pools (20U/L and 415U/L) spiked with various interferents.
- Data Provenance: Not explicitly stated.
Method Comparison:
- RX Daytona: 90 serum samples (6 spiked)
- RX Imola: 93 serum samples (4 spiked)
- Data Provenance: "Patient samples," but no country of origin or retrospective/prospective information is given.
Matrix Comparison:
- RX Daytona (Lithium Heparin): Minimum of 72 matched patient sample pairs.
- RX Daytona (Potassium EDTA): Minimum of 71 matched patient sample pairs.
- RX Imola (Lithium Heparin): Minimum of 71 matched patient sample pairs.
- RX Imola (Potassium EDTA): Minimum of 71 matched patient sample pairs.
- Data Provenance: "Patient samples," but no country of origin or retrospective/prospective information is given.
Expected Values/Reference Range:
- 40 normal donors (16 Male, 24 Female; age 17-69).
- Data Provenance: "human serum from 40 normal donors." No country of origin or retrospective/prospective information is given.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

There is no mention of experts being used to establish ground truth for the test set. The performance is based on analytical measurements and comparisons to a predicate device, which is typical for in vitro diagnostic (IVD) device submissions of this nature.

No number of experts mentioned.
No qualifications mentioned.

4. Adjudication Method for the Test Set

Not applicable. The study involves quantitative analytical measurements and comparisons rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating a diagnostic image interpretation aid rather than an in vitro diagnostic reagent.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies presented are all standalone performance evaluations of the analytical device (reagent used on the RX Daytona and RX Imola instruments). There is no human-in-the-loop component described for these performance characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this in vitro diagnostic device is primarily established by:

Measured concentrations: For precision, linearity, detection limits, and analytical specificity, the "truth" is the actual or expected concentration of CK-MB in the prepared samples or controls.
Predicate device measurements: For method comparison, the "ground truth" or reference is the results obtained from the legally marketed predicate device (Roche CK-MB Kit on Hitachi 717).
Statistical analysis: For characteristics like precision, correlation coefficients serve as measures of agreement and performance.
Clinical consensus/literature: For expected values/reference range, the results are compared against an established range (<25 U/L) from cited literature.

8. The Sample Size for the Training Set

No explicit "training set" is mentioned for this device performance evaluation. IVD performance studies typically focus on validation of a pre-defined method rather than training an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned in the provided text.

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