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510(k) Data Aggregation
(252 days)
Randox RX Daytona Plus Alkaline Phosphatase (ALP)
The Randox RX Daytona Plus Alkaline Phosphatase (ALP) test system is intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum and lithium heparinized plasma. Measurements of alkaline phosphatase are used in the diagnosis, treatment and investigation of hepatobiliary disease and in bone disease.
The Randox RX Daytona Plus Alkaline Phosphatase (ALP) assay consists of ready to use reagent solutions.
Here's a breakdown of the acceptance criteria and study information for the Randox RX Daytona Plus Alkaline Phosphatase (ALP) device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Linearity/Reportable Range | LoQ / L1 pool: ≤ 20% deviation to target | Met (linear regression r = 1.000, claimed range 8 – 918 U/L) |
| L2 to L11: 0.95 | Met (r = 1.000) | |
| Analytical Specificity | Control pool within 10% of decision level target | Met (Interferents did not demonstrate significant interference up to tested concentrations) |
| Control and test pools recover within 10% of each other | Met (Interferents did not demonstrate significant interference up to tested concentrations) |
Study Details
2. Sample Size Used for the Test Set and Data Provenance:
- Precision/Reproducibility: Not explicitly stated for specific test sets, but 80 determinations per sample (QC or serum) were performed for each of the two reagent lots. Human serum samples (altered and unaltered, some spiked or diluted) were used. Data provenance is not explicitly stated beyond "human serum samples."
- Linearity/Reportable Range: 11 levels of samples were prepared. Each level was run in replicates of five. Provenance of these samples is not specified.
- Detection Limit: Not explicitly stated for a separate "test set" size, but the LoD was based on 240 determinations using 4 low-level samples. Provenance not specified.
- Analytical Specificity: Not explicitly stated for a separate "test set" size for each interferent, but the study implies testing at ALP concentrations of 80 U/I and 240 U/I. Provenance not specified.
- Method Comparison with Predicate Device: 106 serum patient samples. Data provenance is not explicitly stated but implies patient samples from the UK, given the manufacturer's location. The study was retrospective, comparing the new device results against an existing predicate device using collected samples.
- Matrix Comparison: 46 matched patient sample pairs (serum and lithium heparin plasma). Provenance not explicitly stated.
- Expected Values/Reference Range Verification: Human serum from 30 normal donors. Provenance not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This document describes the analytical performance of an in vitro diagnostic device (a laboratory test for Alkaline Phosphatase activity). The "ground truth" for such devices is typically established through reference methods, certified standards, or consensus values from established quality control materials, rather than expert interpretation of images or patient data. The document does not mention the use of experts to establish ground truth for the analytical performance studies.
- For the precision study, control materials and altered/unaltered human serum samples were used.
- For linearity, pooled samples with known concentrations were used.
- For method comparison, the predicate device (Siemens Alkaline Phosphatase (ALPAMP) Assay, K991576) served as the reference for comparison.
4. Adjudication Method for the Test Set:
- Not Applicable. As noted above, this study evaluates the analytical performance of an in vitro diagnostic device, not interpretive performance requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
- Not Applicable. This is an evaluation of an in vitro diagnostic device for quantitative chemical analysis, not an AI-powered diagnostic imaging system requiring human reader studies.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-loop Performance) Was Done:
- Yes, a standalone study was done. The entire submission details the performance of the Randox RX Daytona Plus Alkaline Phosphatase (ALP) system itself, comprising reagents and the RX Daytona Plus analyzer. This is the inherent nature of an in vitro diagnostic test; its performance is measured independently of human interpretation of the result, though human operators perform the test and interpret the clinical significance of the result. The performance metrics (precision, linearity, detection limits, accuracy/method comparison) are all measures of the device's standalone analytical capabilities.
7. The Type of Ground Truth Used:
- Reference Methods/Comparative Devices and Spiked/Diluted Samples:
- Precision and Linearity: Values derived from known concentrations in quality control materials, spiked samples, or diluted samples where the true value is calculable.
- Method Comparison: The predicate device (Siemens Alkaline Phosphatase (ALPAMP) Assay, K991576) served as the comparative "ground truth" to establish substantial equivalence.
- Detection Limits: Determined statistically using defined protocols (CLSI guideline EP17-A2).
- Analytical Specificity: Known concentrations of interferents added to known ALP concentrations.
8. The Sample Size for the Training Set:
- Not Applicable. The document describes a traditional analytical performance study for an in vitro diagnostic assay, not an AI/machine learning model that requires a training set. The device is a chemical reagent and analyzer system.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. See point 8.
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