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The Randox Calcium (Ca) device is intended for the quantitative in vitro determination in serum, plasma and urine. This product is suitable for use on the RX series analyzer, RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.

The Randox Calcium (Ca) kit consists of a ready to use reagent solution.

The Randox Calcium (Ca) device is an in vitro diagnostic intended for the quantitative determination of calcium concentration in serum, plasma, and urine on the RX series analyzer RX daytona plus. The device demonstrates substantial equivalence to the predicate device, the ADVIA Chemistry Calcium_2 (CA_2) Method (K083386), based on performance characteristics including precision, linearity, analytical specificity, and method comparison.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Acceptance criteria are often implied by context (e.g., successful demonstration of performance consistent with CLSI guidelines, or by direct comparison with predicate device performance which sets an implicit standard). For precision, specific numerical thresholds are listed based on the demonstrated performance of the predicate device or generally accepted clinical chemistry standards. For linearity and method comparison, r ≥ 0.99 and a linear regression close to y=x are standard and implied criteria for equivalence. For analytical specificity, a deviation of < ±10% is explicitly stated as the sponsor's acceptance criterion.

2. Sample sizes used for the test set and the data provenance:

• Precision (Serum): Not explicitly stated, but "two levels of controls, calibration material and human serum samples for Calcium" were tested across two lots. Each run included two replicates per sample, tested twice per day for 20 non-consecutive days. This implies a significant number of measurements for each level/lot (e.g., 2 samples * 2 replicates * 2 times/day * 20 days = 160 data points per lot/level).
• Precision (Urine): Similar to serum precision, "two levels of urine controls, calibration material and human urine samples for Calcium" were tested across two lots, with two replicates per run, twice per day for 20 non-consecutive days.
• Linearity (Serum): 11 levels of samples were prepared.
• Linearity (Urine): 11 levels of samples were prepared.
• Analytical Specificity (Serum): Not explicitly stated, but interferent levels were tested at Calcium concentrations of 8 mg/dL and 12 mg/dL.
• Analytical Specificity (Urine): Not explicitly stated, but interferent levels were tested at Calcium concentrations of 9 mg/dL and 22.8 mg/dL.
• Method Comparison (Serum): 111 serum patient samples.
• Method Comparison (Urine): 100 urine patient samples.
• Matrix Comparison (Serum vs Plasma): 47 matched patient sample pairs.

Data Provenance: The document does not specify the country of origin for the patient samples. The studies are described as analytical performance studies, meaning they are likely retrospective in the sense that samples were collected and then analyzed for the study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is an in vitro diagnostic (IVD) device for quantitative biochemical measurement. The "ground truth" for such devices is established by reference methods or validated comparative methods, not typically by expert interpretation of images or clinical assessments in the same way as, for example, an imaging AI device. For the method comparison studies, the predicate device (ADVIA Chemistry Calcium_2 (CA_2) Method) serves as the reference for comparison, which itself is a cleared IVD. Therefore, "experts" in the sense of clinicians or radiologists establishing ground truth are not applicable here.

4. Adjudication method for the test set:

Not applicable. The performance is evaluated using quantitative measurements against recognized analytical standards and comparisons with a predicate device, not through adjudication of expert interpretations.

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:

Not applicable. This is an in vitro diagnostic device, not an AI-powered diagnostic imaging or decision-support system that involves human readers interpreting cases.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the studies presented are all standalone performance evaluations of the Randox Calcium (Ca) assay and the RX daytona plus analyzer. This device provides a quantitative measurement and does not involve human-in-the-loop interpretation once the sample is processed by the instrument.

7. The type of ground truth used:

The ground truth or reference standard for this type of device is established through:

• Reference materials/calibrators: used for precision and linearity studies.
• Comparative method (Predicate Device): For method comparison, the results generated by the predicate device (ADVIA Chemistry Calcium_2 (CA_2) Method) on patient samples served as the comparative "truth" or reference.
• Spiked samples: For analytical specificity studies, known concentrations of interferents were added to samples with known calcium concentrations.

8. The sample size for the training set:

Not applicable. This is a chemical assay, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The "training" of the assay involves the development and optimization of the reagent formulation and instrument parameters, which is a chemical and engineering process, not a data-driven training process in the AI context.

9. How the ground truth for the training set was established:

Not applicable, as there is no "training set" in the context of an AI algorithm. The performance of the chemical assay is established through rigorous analytical validation studies as described above.

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The Randox Laboratories Limited Calcium Test Kit is an in vitro diagnostic reagent for the quantitative determination of calcium in human serum. This method is based on the interaction of calcium with Arsenazo III to form a coloured complex which can be measured at 650nm. The intensity of the final colour is directly proportional to the calcium concentration. Measurements of calcium are used in the diagnosis and treatment of parathyroid disease, malignant diseases with and without bone involvement, chronic renal failure and a variety of bone diseases.

The Randox Laboratories Limited Calcium Test Kit is an in vitro diagnostic reagent for the quantitative determination of calcium in human serum. This method is based on the interaction of calcium with Arsenazo III to form a coloured complex which can be measured at 650nm. The intensity of the final colour is directly proportional to the calcium concentration.

The provided text is a 510(k) clearance letter from the FDA for the "Randox Calcium" device, and an "Indications for Use" statement. This document does not contain the specific details about acceptance criteria, device performance studies, or the methodologies used to establish ground truth as requested in your prompt.

The document states that the Randox Laboratories Limited Calcium Test Kit is:

• An in vitro diagnostic reagent
• For the quantitative determination of calcium in human serum
• Based on the interaction of calcium with Arsenazo III to form a coloured complex
• Which can be measured at 650nm
• The intensity of the final colour is directly proportional to the calcium concentration.
• Measurements of calcium are used in the diagnosis and treatment of conditions such as parathyroid disease, malignant diseases with and without bone involvement, chronic renal failure, and a variety of bone diseases.

It also notes that the test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

However, it does not include:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

This document is typically a summary of the FDA's decision regarding substantial equivalence, not the detailed study report itself. To find the specific information you are looking for, you would generally need to refer to the full 510(k) submission document or supporting studies, which are not included in this extract.

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