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For the quantitative in vitro determination of Cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders.

The Cholesterol kit assay consists of ready to use reagent solutions.

CATALOGUE NUMBER: CH8310

R1. Reagent 4 x 20 ml

REAGENT COMPOSITION

Contents: R1. Reagent 4-Aminoantipyrine, Phenol, Peroxidase (E.C.1.11.1.7, Horse Radish, +25°C), Cholesterol esterase (E.C.3.1.1.13. Pseudomonas, +37°C), Cholesterol oxidase (E.C.1.1.3.6. Nocardia, +37°C), Sodium Azide

Concentrations in the Test: 0.25 mmol/l, 6.00 mmol/l, >=0.50 U/ml, >= 0.20 U/ml, >=0.10 U/ml, 0.09%

MATERIALS REQUIRED BUT NOT PROVIDED: Randox Assayed Multisera Level 2 (Cat. No. HN 1530) and Level 3 (Cat. No. HE 1532); 510(k) # K942458, Randox Calibration Serum Level 3 (Cat. No. CAL 2351); 510(k) # K053153, RX series Saline (Cat. No. SA 8396)

Here's a breakdown of the acceptance criteria and study information for the Randox Laboratories Ltd. Cholesterol device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for all tests in a single table, but rather presents the performance results of various analytical studies that demonstrate the device's capability. I've compiled the relevant performance data from the document into a table, noting the implicit acceptance measures (e.g., meeting CLSI guidelines, certain correlation coefficients, or imprecision percentages).

2. Sample Sizes and Data Provenance for the Test Set

• Precision/Reproducibility:
  • Controls: Not explicitly stated as "sample size" but data is reported for commercial control materials (717UE, 724UE, 952UN).
  • Patient Samples: 4 concentrations of unaltered human serum samples (3 diluted, 1 spiked for Linearity Pool, 1 Sensitivity Pool). Each sample run in 2 replicates per run, twice per day for 20 non-consecutive days, using 2 reagent lots on 2 RX Daytona plus systems.
  • Data Provenance: "unaltered human serum samples" implies human origin, likely retrospective for spiking/dilution. No country of origin is specified.
• Linearity/Assay Reportable Range:
  • Sample Size: 11 levels of samples covering the measuring range. Each level run in 5 replicates.
  • Data Provenance: "linearity samples" were prepared. Implies in-vitro prepared samples to cover the range, likely based on human serum/plasma.
• Detection Limit (LoD), Limit of Blank (LoB), Limit of Quantitation (LoQ):
  • Sample Size: LoD was based on 240 determinations with 4 low-level samples.
  • Data Provenance: Not specified, but generally prepared samples for low-level determination.
• Analytical Specificity (Interference):
  • Sample Size: Not explicitly stated for the number of interferent samples, but tested at Cholesterol concentrations of 150 mg/dl and 250 mg/dl for each interferent.
  • Data Provenance: Prepared samples spiked with interferents.
• Method Comparison with Predicate Device:
  • Sample Size: 107 serum patient samples.
  • Data Provenance: "serum patient samples" spanning 25 to 599 mg/dl. Retrospective. No country of origin specified.
• Matrix Comparison:
  • Sample Size (Lithium Heparin): Minimum of 54 matched patient sample pairs (serum vs. lithium heparin plasma).
  • Sample Size (Potassium 2 EDTA): Minimum of 50 matched patient sample pairs (serum vs. potassium 2 EDTA plasma).
  • Data Provenance: "Patient samples were drawn in matched pairs". Retrospective from human subjects. No country of origin specified.

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

This device is an in vitro diagnostic (IVD) for quantitative measurement of cholesterol. The "ground truth" for such devices is established by precise laboratory reference methods or established commercially available controls and calibrators with known values.

• No "experts" in the sense of radiologists or pathologists establishing ground truth as would be the case for imaging devices.
• Ground truth is established by:
  • Reference materials (e.g., NIST 1952a for the calibrators, mentioned under traceability).
  • Established analytical methods used by the predicate device and in clinical laboratories.
  • CLSI guidelines for experimental design and data analysis.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative IVD device. Adjudication methods (like 2+1, 3+1) are typically used for qualitative or semi-quantitative assessments, especially in imaging or pathology, where human expert discrepancy resolution is needed. For quantitative chemical measurements, the ground truth is often numerical and objectively determined.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is an in vitro diagnostic device for chemical analysis of cholesterol, not an imaging or qualitative assessment device involving human readers. Therefore, an MRMC study is not relevant.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, the entire performance evaluation presented is a standalone study of the device (Cholesterol assay on the RX Daytona plus system). The device performs the analytical measurement autonomously once the sample is loaded. The studies demonstrate the analytical performance of the device itself.

7. Type of Ground Truth Used

The ground truth for the performance studies is multi-faceted:

• Reference Materials: Randox Calibration Serum Level 3 is traceable to Cholesterol reference material NIST 1952a. This is a primary ground truth for calibration and accuracy.
• Predicate Device: For method comparison studies, the predicate device (Randox Cholesterol reagent, K923504) serves as a comparative ground truth, aiming to demonstrate substantial equivalence rather than absolute biological truth.
• CLSI Guidelines: The studies adhere to CLSI (Clinical and Laboratory Standards Institute) guidelines (EP5-A2 for precision, EP6-A for linearity, EP17-A2 for detection limits, EP9-A2 for method comparison), which represent an industry-accepted "ground truth" for how these analytical performance characteristics should be determined and evaluated.
• Prepared Samples: For linearity, sensitivity, detection limits, and interference, samples were prepared to known concentrations or spiked with known substances to create specific "ground truth" scenarios.

8. Sample Size for the Training Set

There is no mention of a "training set" in the context of machine learning or AI, as this device is a traditional in vitro diagnostic reagent system, not an AI/ML-based device.

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

Not applicable, as there is no training set for an AI/ML algorithm in this context.

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The RX Daytona Plus Chemistry analyzer is a bench top fully automated random access clinical chemistry analyzer intended for use in clinical laboratories. It is intended to be used for a variety of assay methods. The RX Daytona Plus includes an optional Ion Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum and urine. The RX Daytona Plus is not for Point-Of-Care testing.

Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.

Potassium measurements monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.

The RX Daytona Plus AST reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate aminotransferase (AST) in human serum. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

The RX Daytona Plus is a bench-top fully automated random access clinical analyser intended for use in clinical laboratories.

The RX Daytona Plus contains an ISE .module for the measurement of Potassium, Chloride and Sodium. The RX Daytona Plus has the capacity to perform up to 270 photometric tests or 450 tests per hour with ISE's and offers primary tube sampling, on-board sample dilution and a cooled reagent compartment.

• Cuvette wash system .
• STAT facility .
• Direct interface with host computer .
• . Automatic re-run and pre-dilution functions

The RX Daytona Plus uses dedicated software for easy access to all system facilities and functions. operating functions and provides a comprehensive data management system.

Reagents:
AST reagent is supplied in a kit containing:

• . 4 x 20.0 mL Buffer/ enzyme
• . 4 x 7.0 mL α-οχοςlutarate/Coenzyme.

The primary reagent contains L-Aspartic acid, MDH, Tris Buffer and preservative, The secondary reagent contains a-oxoglutarate, NADH and preservatives.

ISE Electrodes, Sodium, Potassium and Chloride are comprised of ISE Calibrator H and L, ISE diluent, ISE reference solution and ISE etching solution.

Here's a summary of the acceptance criteria and study information for the RX Daytona Plus Instrument, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the results of the precision, linearity, detection limit, analytical specificity, and method comparison studies. The device aims to demonstrate substantial equivalence to its predicate devices for each analyte (AST, Sodium, Potassium, Chloride) in the relevant sample types (serum, urine). The performance metrics reported directly represent if these implied criteria were met.

2. Sample Sizes Used for the Test Set and Data Provenance

• Precision/Reproducibility:

  • AST, Sodium, Potassium, Chloride (Serum): Two levels of control material, calibration material, unaltered human serum samples, and altered human serum samples. Tested twice per day for 20 non-consecutive days, with two replicates per sample. This totals approximately 80 test points per sample type for control/calibrator, and 40 test points per patient pool (20 days * 2 replicates).
  • Sodium, Potassium, Chloride (Urine): Two levels of urine controls and two urine patient pools. Tested twice per day for 20 non-consecutive days, with two replicates per sample. Totals approximately 80 test points per control, and 40 test points per patient pool.
  • Data Provenance: Not explicitly stated, but the submission is from Randox Laboratories Limited in the United Kingdom, suggesting the studies were likely conducted there. The samples were human serum and urine. Retrospective or prospective nature is not specified, but the "non-consecutive days" suggests prospective testing over a period.

• Linearity/Assay Reportable Range:

  • AST, Sodium, Potassium, Chloride (Serum & Urine): Studies performed at 11 levels.
  • Data Provenance: Implied to be derived from the UK.

• Detection Limit (AST):

  • 360 determinations, with 1 blank and 2 low-level samples.
  • Data Provenance: Implied to be derived from the UK.

• Analytical Specificity (Interference):

  • Interferents (Hemoglobin, Bilirubin, Triglycerides, Intralipid, various drugs) were "spiked" into relevant control/sample solutions. The number of samples/replicates isn't specified beyond this.
  • Data Provenance: Implied to be derived from the UK.

• Method Comparison with Predicate Device:

  • AST (Serum): 92 serum patient samples.
  • Sodium (Serum): 50 serum patient samples.
  • Sodium (Urine): 42 urine patient samples.
  • Potassium (Serum): 56 serum patient samples.
  • Potassium (Urine): 43 urine patient samples.
  • Chloride (Serum): 61 serum patient samples.
  • Chloride (Urine): 44 urine patient samples.
  • All samples were tested in singlicate across 5 working days.
  • Data Provenance: Not explicitly stated, but given the submitter's location (UK), the data is most likely from the UK. The studies used "patient samples," which suggests real-world specimens, likely collected prospectively for the purpose of the study or retrospectively from a patient cohort.

• Expected Values/Reference-range Verification:

  • Sodium, Potassium, Chloride (Serum): Human serum from 30 normal donors, tested in singlicate.
  • Data Provenance: Implied to be derived from the UK.

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

Not applicable. This device is a clinical chemistry analyzer. The "ground truth" for the test set values (e.g., concentrations of AST, sodium) is established by reference methods or validated laboratory procedures, not by human expert interpretation like in imaging studies. The predicate device's performance also serves as a benchmark.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in subjective diagnostic tasks, such as radiology image interpretation. In this context, the "ground truth" values for chemical analytes are obtained through highly standardized and quantitative laboratory methods (e.g., reference methods, predicate device results).

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

No. An MRMC study is relevant for evaluating the impact of AI on human readers' performance in diagnostic tasks (e.g., radiology). This device is a fully automated chemistry analyzer, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, essentially all the performance data (precision, linearity, detection limits, analytical specificity, method comparison) reflects the standalone performance of the RX Daytona Plus Chemistry Analyzer as an automated instrument. There is no human-in-the-loop aspect for the analysis itself; human intervention is only involved in loading samples and interpreting the final results generated by the machine.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established using a combination of:

• Reference materials/control materials: For precision and linearity studies.
• Validated methods/Predicate device results: For method comparison studies, where the results from the RX Daytona Plus were compared against a legally marketed predicate device (Randox RX Imola Chemistry Analyzer with ISE, Randox AST assay).
• Gravimetric preparation from purified salts: For ISE (Sodium, Potassium, Chloride) calibrators traceability.
• Standardized reference procedures (JSCC TS01): For AST traceability.
• Clinical literature: For establishing expected values/reference ranges.

8. The Sample Size for the Training Set

Not applicable. This is a traditional automated chemistry analyzer, not a machine learning or AI-driven device that requires a training set in the typical sense. The "parameters" and "algorithms" (e.g., Nernst equation for ISE, kinetic reaction for AST) are based on established chemical and physical principles, not learned from a large dataset.

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

Not applicable, as there is no "training set" for this type of device. The operating principles are based on fundamental scientific laws and established chemical diagnostic assays.

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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.

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.

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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The Randox CSF Controls Levels 2 and Level 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for Clinical Chemistry systems. This device is intended for prescription use only.

The Randox CSF controls consist of a buffered aqueous solution with biological materials; they are supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the following analytes at both levels: Chloride, Glucose, IgG, Lactic Acid, Sodium, Total Protein (Pyrogallol Red), and % Total Protein quoted for Electrophoresis regions at both levels: Albumin, Alpha-1-Globulin, Alpha-2-Globulin, Beta Globulin and Gamma Globulin.

The Randox CSF Controls Levels 2 and 3 are in vitro diagnostic devices. The acceptance criteria and the study proving the device meets these criteria are detailed below, primarily focusing on stability and value assignment studies.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Open Vial Stability: For open vial stability, a "set" of CSF Controls Levels 2 and 3 was used. On day 14, a "fresh sample" was reconstituted and compared. This implies at least two reconstituted vials (one fresh, one 14-day aged) for comparison for each control level, and "replicates" were performed, though the specific number of replicates is not stated.
• Shelf Life (Real-time Stability): For real-time stability, "10 sets of each control" (Level 2 and Level 3) were used. This means 10 vials of Level 2 and 10 vials of Level 3 were stored at ultra-frozen conditions, and another 10 vials of Level 2 and 10 vials of Level 3 were stored at routine temperature (2-8°C).
• Value Assignment: "Several replicates" were used for both electrophoresis measurements and for the remaining analytes, but the exact number of replicates is not specified.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that it's a submission for a new device manufactured by Randox Laboratories Limited in the United Kingdom, it's highly probable the studies were conducted prospectively by the manufacturer.

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

• The document describes the establishment of target values for the control material (which serves as the "ground truth" for quality control purposes).
• For electrophoresis analytes, vials were "analyzed at an external site." The number of experts or the specific qualifications of those performing the analysis are not explicitly stated, but it's implied that these are qualified professionals at a specialized laboratory.
• For other analytes, comparison was made against a "master lot." This does not involve human expert interpretation in the same way as, for example, image analysis.

4. Adjudication Method for the Test Set

• Adjudication methods like 2+1 or 3+1 typically apply to studies where human interpretation of results is involved and discrepancies need to be resolved.
• For laboratory control materials, the "ground truth" (target values and acceptable ranges) is established through analytical processes and statistical analysis of multiple replicates. Discrepancies would be resolved by re-running samples, checking instrument calibration, or investigating analytical issues, rather than through expert adjudication in the human-reader sense. The value assignment methods described involve calculating means of "several replicates" and comparing against established criteria, implicitly handling variability through statistical methods rather than human adjudication.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
• This device is a quality control material for in vitro diagnostic tests, not an algorithm or imaging device that requires human interpretation or comparison of human reader performance. The studies focus on the analytical performance (stability, value assignment) of the control material itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This device is a quality control material, not an algorithm. Therefore, a standalone performance study (in the context of an algorithm's performance independent of human input) is not applicable or described. The performance studies focus on the intrinsic properties and stability of the control material.

7. The Type of Ground Truth Used

• The ground truth for this device (Randox CSF Controls) is its assigned target values and acceptable ranges for various analytes.
• This ground truth is established through:
  • Analytical Testing and Expert Consensus (implicit for electrophoresis): For electrophoresis analytes (Albumin, Alpha-1-globulin, etc.), the mean of "several replicates" analyzed at an external site is taken, and percentages of total protein are calculated. This implies the analytical results from a qualified external lab are considered the definitive "ground truth."
  • Comparison to a Master Lot and Analytical Testing: For other analytes (Chloride, Glucose, Immunoglobulin G, Lactate, Sodium, Total Protein), the test controls are assessed against a "master lot" using analytical methods. The mean of several replicates and CV are calculated, and recovery of the master lot is measured against predefined acceptance criteria.

8. The Sample Size for the Training Set

• The concept of a "training set" is typically associated with machine learning algorithms.
• For this quality control material, there isn't a "training set" in that sense. The manufacturing process and formulation are developed, and then the stability and value assignment studies (described above) act as validation and characterization. The "master lot" mentioned in value assignment method 2 could be considered a reference or calibration standard that helps establish the "ground truth" for new lots, but it's not a training set for an AI model.

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

• As there is no "training set" in the context of an algorithm for this device, this question is not fully applicable.
• However, if we interpret "ground truth for the training set" as the basis for establishing the expected values for the control material, it's established through:
  • Reference materials and methods: For individual analytes, traceable sources are used, such as "Synthetic Analytical Grade chemical" from commercial suppliers (e.g., SIGMA, EUROPA) or biological materials "derived from Human serum" (e.g., Intergen).
  • Comprehensive analytical testing: As described in section 9 "Summary of Value Assignment," extensive laboratory analysis involving "several replicates" and comparison to a master lot or external site analysis is performed to determine the "Target Value" and "Acceptable range" for each analyte.

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Randox Benzodiazepine Calibrator Set: The Randox Benzodiazepine Calibrator set consists of liquid calibrators containing Oxazepam. There are 5 levels of calibrator. They have been developed for use in the calibration of the RX series analysers in human urine, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.

Randox Benzodiazepine Controls Level 1 & 2: The Randox Benzodiazepine Controls are liquid controls containing Oxazepam. There are 2 levels of controls. They have been developed for use in the quality control and validation of Benzodiazepine assay on the RX series analysers in human urine, which includes the RX Daytona and the RX Imola. This in vitro diagnostic device is intended for prescription use only.

The Benzodiazepine Calibrator Set contains 5 levels of calibrator containing the specific drug Oxazepam. The Calibrators are spiked at 4 different levels which assess below, at and above the cutoff of 200 ng/ml.

The Benzodiazepine Controls are manufactured at two levels, one below the cutoff and one above the cutoff of 200 ng/ml.

The base matrix used for the manufacture of Randox Benzodiazepine Calibrators and Controls is Drug Free Human Urine.

The Benzodiazepine Calibrators and Controls contain the specific drug Oxazepam. The Oxazepam is supplied by Cerilliant Corporation the accuracy of which is ensured by purity determinations (GC/FID, HPLC and NMR) and gravimetric preparation using balances calibrated with NIST traceable weights.

Randox Benzodiazepine Calibrators and Controls have been designed for in vitro diagnostic use only. They should not be pipetted by mouth and the normal precautions for handling laboratory reagents should be applied. Randox Benzodiazepine Calibrators and Controls contain sodium azide at 0.05%.

The provided document describes the Randox Benzodiazepine Calibrator Set and Randox Benzodiazepine Controls Level 1 and 2. This device is a set of calibrators and controls used for the calibration and quality control of Benzodiazepine assays on Randox RX series analyzers in human urine.

Here's an analysis of the acceptance criteria and study data provided:

1. A table of acceptance criteria and the reported device performance

The document details two types of stability studies, each with specific acceptance criteria and reported performance:

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

• Open Vial Stability:
  • Test set: Three batches of calibrators (242516, 51110, 61110) were tested, and three batches of controls (250-251DA, 51110, 61110) were tested. For each batch, a set of calibrators/controls was opened and assessed at Day 7, 21, and 28 against a freshly opened set.
  • Data Provenance: The studies were conducted by Randox Laboratories Limited, United Kingdom. The data is prospective, generated specifically for this submission.
• Real-Time Shelf Life:
  • Calibrators: One batch (023-027DA) was tested, with 5 calibrator sets set aside and assessed at 1, 3, 6, 9, and 12 months.
  • Controls: Two batches (482DA, 483DA) were tested, with 5 sets of controls set aside and assessed at 3, 4, 6, 9, and 12 months.
  • Data Provenance: The studies were conducted by Randox Laboratories Limited, United Kingdom. The data is prospective.
• Accelerated Shelf Life:
  • Calibrators: One batch (023-027DA) was tested, with six sets stored at +37°C and assessed at 1, 3, 5, 7, 10, and 12 days.
  • Data Provenance: The studies were conducted by Randox Laboratories Limited, United Kingdom. The data is prospective.
• Value Assignment (Nest Testing):
  • Test set: Ten replicates of the test calibrators/controls were assessed against a master lot. The specific number of batches tested for value assignment is not explicitly stated beyond "each new batch."
  • Data Provenance: The studies were conducted by Randox Laboratories Limited, United Kingdom. The data is prospective.

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

This information is Not Applicable to this device. This device is a calibrator and control set for an in vitro diagnostic assay. Its performance is measured by chemical and analytical stability and accuracy against a known standard, not by expert interpretation of clinical images or data. The "ground truth" for the test set (e.g., the concentration of Oxazepam) is established by the manufacturer (Randox) based on gravimetric preparation using NIST traceable weights and purity determinations.

4. Adjudication method for the test set

This information is Not Applicable. Clinical adjudication methods (like 2+1, 3+1) are used for evaluating diagnostic performance involving human interpretation, especially in imaging studies. For a chemical calibrator/control, performance is determined by meeting pre-defined analytical specifications.

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

This information is Not Applicable. This device is not an AI algorithm or a diagnostic tool that involves human readers interpreting cases. It is a calibrator/control for an automated assay.

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

This information is Not Applicable. This device is a calibrator/control, not a standalone algorithm. Its performance is evaluated through analytical stability and value assignment studies in conjunction with the RX series analyzers and Benzodiazepine Assay.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the Randox Benzodiazepine Calibrator Set and Controls is the known concentration of Oxazepam. This is established through:

• Gravimetric preparation: Oxazepam is spiked into the calibrators and controls at various concentrations.
• Traceability to NIST traceable weights: The accuracy of the Oxazepam is ensured by Cerilliant Corporation through purity determinations (GC/FID, HPLC, and NMR) and gravimetric preparation using balances calibrated with NIST traceable weights.
• Drug-free human urine: The base matrix for the calibrators and controls is drug-free human urine, ensuring a clear matrix for spiking.

8. The sample size for the training set

This information is Not Applicable. This device is not an AI/ML algorithm that requires a training set. The "samples" used in its development and validation are the manufactured batches of calibrators and controls themselves, which are then subjected to the stability and value assignment studies.

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

This information is Not Applicable, as there is no "training set" in the context of an AI/ML algorithm for this device. The equivalent of "ground truth" for its manufacturing and quality control, as described in point 7, is established through precise chemical formulation, gravimetric preparation, and analytical verification of the Oxazepam concentration and purity traceable to NIST standards.

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The HbAlc Controls Level 1 and 2 are intended for in vitro diagnostic use as quality control material for use to verify the performance of laboratory testing procedures of HbAlc on clinical chemistry systems. This in vitro diagnostic device is intended for prescription use only.

HbA1c Controls are manufactured at two levels, Level 1 and Level 2. Each control is prepared from haemolysed human blood with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilised form in 2x0.5ml vials and require reconstitution with 0.5ml of distilled water.

The provided document describes the Randox HbA1c Controls Level 1 and 2, which are quality control materials for verifying the performance of laboratory testing procedures of HbA1c on clinical chemistry systems. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets an inherent set of acceptance criteria for its own performance.

Therefore, it is important to note that the acceptance criteria and study described below are derived from the information available in the 510(k) summary, primarily focusing on the value assignment process for the controls and the comparison to the predicate device, rather than a standalone clinical study on the device's diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of diagnostic accuracy or a clinical study for the quality control material itself. The "testing results" mentioned in the conclusion refer to the overall evaluation for substantial equivalence to the predicate device, which includes the value assignment process and stability data.

• Sample Size for Value Assignment: For value assignment, "at least two replicates on each clinical chemistry analyser" are used to calculate a target value. External laboratories contribute NGSP aligned values. The specific number of these external laboratories or the total number of replicates across all analyzers is not stated.
• Data Provenance: The NGSP aligned values are taken from "external laboratories." The country of origin is not specified, nor is whether the data is retrospective or prospective.

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

This section is not applicable in the traditional sense for a quality control device. The "ground truth" for the controls is the assigned target value.

• Number of Experts: Not applicable. The value assignment method relies on consensus mean from "external laboratories" using NGSP certified methods. These laboratories are assumed to have qualified personnel, but individual experts are not quantified or specified.
• Qualifications of Experts: Not specified. It's implied that the external laboratories use "NGSP certified methods," suggesting that the personnel performing these measurements are qualified to do so, but their specific qualifications (e.g., years of experience, specific certifications) are not detailed.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" for diagnostic performance in the context of human adjudication for this quality control material. The value assignment process uses a consensus mean.

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

No. An MRMC comparative effectiveness study is designed to assess the performance of a diagnostic device or algorithm in conjunction with human readers. This document describes a quality control material, not a diagnostic device intended to be used by human readers to interpret clinical cases.

6. If a Standalone Study Was Done

Yes, in the sense that the device's performance characteristics (stability and value assignment) were evaluated independently. However, this is not a "standalone" study in the typical AI/diagnostic algorithm context focusing on diagnostic accuracy.

• Standalone Performance: The stability studies (opened and unopened) and the value assignment process describe the performance of the Randox HbA1c Controls themselves.
  • Value Assignment: Target values are calculated as the mean of at least two replicates on each clinical chemistry analyzer, and an acceptance criterion for CV (≤ 10%) is applied. A +/-20% range is applied to the assigned target value.
  • Stability: Open stability is 1 month at 2-8°C. Unopened stability is until the expiration date at 2-8°C.

7. The Type of Ground Truth Used

The "ground truth" for the HbA1c Controls is their assigned target value. This is established through:

• Consensus Mean: Aggregation of values obtained from "external laboratories" using "NGSP certified methods."
• Traceability: Traceable to IFCC by a master equation and NGSP aligned values.
• Reference Material: Traceable to IFCC by master equation.

8. The Sample Size for the Training Set

Not applicable. This device is a quality control material and does not involve AI/machine learning algorithms that require a "training set" for model development.

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

Not applicable, as there is no training set for this type of device.

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The Randox Aldolase Control Level 2 and Aldolase Control Level 3 are intended for in vitro diagnostic use as assayed quality control materials for the quantitative determination of aldolase on the clinical chemistry analyzers indicated in the package insert. This device is for prescription use only.

Randox Aldolase Control is manufactured at two levels, Level 3. Each control is prepared from human serum with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilized form in 3x1 mL vials and require reconstitution with 1 mL of distilled water.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study for Randox Aldolase Control Level 2 and Level 3

This device is a quality control material, and its performance is evaluated based on its stability and the accuracy and precision of its assigned values when used with specific clinical chemistry analyzers.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Open Vial Stability Test Set: The sample size is not explicitly stated in terms of the number of vials used, but it involved "reconstituting vials of Aldolase Controls." The data provenance is internal testing by Randox Laboratories Limited in the United Kingdom. It is a prospective study assessing stability over time.
• Unopened Shelf Life Test Set: The sample size referred to is "three batches of the Aldolase controls." The data provenance is internal testing by Randox Laboratories Limited in the United Kingdom. It is a prospective (real-time) study assessing stability over 24 months.
• Value Assignment Test Set: For each level (2 and 3) on each analyzer (RX Daytona and Beckman Coulter AU640), the sample size (N) was 10 replicates. The data provenance is internal testing by Randox Laboratories Limited in the United Kingdom. This appears to be a prospective study during the value assignment process.

3. Number of Experts and Qualifications for Ground Truth

The concept of "experts" and their qualifications for establishing ground truth isn't directly applicable for a quality control material where the "ground truth" is typically a target concentration derived through a stringent, standardized "nest testing" process.

For the value assignment:

• The process involves "nest testing," where a new lot is assessed against a "master lot of controls or calibrators." While experts might oversee this, the ground truth is established through a defined analytical comparison process rather than subjective expert consensus. The "master lot" serves as the reference for truth.
• No specific number or qualification of experts is mentioned for the generation of the "master lot" or its ground truth.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging or diagnostic studies where subjective interpretation is involved. For this device (an assayed quality control material), the "ground truth" is established through quantitative measurement and comparison to a master lot. Therefore, no multi-reader adjudication method is mentioned or relevant.

The process for value assignment involves:

• Assessment of new lots against a master lot.
• Ten replicates measured on two or more systems.
• Mean and CV calculated.
• Recovery of the master lot also measured.

This is a quantitative comparison against a known standard (the master lot/calibrator) rather than an interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices that assist human readers in interpreting clinical data (e.g., medical images). The Randox Aldolase Control is a quality control material used to monitor the performance of analytical instruments; it does not involve human readers making diagnostic interpretations.

6. Standalone (Algorithm Only) Performance

This device is not an algorithm or software-only device. It is a physical assayed quality control material. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable. Its performance is measured by its inherent stability and its ability to yield consistent and accurate measurements (based on its assigned values) when run on clinical chemistry analyzers.

7. Type of Ground Truth Used

The ground truth for the Aldolase Controls' values is established by comparison to a master lot of controls or calibrators. This is a reference standard or traceability approach, where the "truth" is derived from established, well-characterized reference materials. The document explicitly states "Nest testing involves assessment of the new lot of controls against a master lot of controls or calibrators."

8. Sample Size for the Training Set

This document does not describe a "training set" in the context of machine learning or AI models, as this device is a chemical reagent control, not an AI or software device. If "training set" is interpreted as the data used to establish the master lot's values, that information is not provided. The data provided pertains to the verification of new lots against an already established "master lot."

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

As noted above, there is no explicit "training set" in the AI/ML sense. For the master lot itself, the general industry practice for establishing the ground truth (assigned values) for such master calibrators or controls involves:

• Using highly accurate reference methods.
• Traceability to international reference standards (if available).
• Rigorous inter-laboratory studies and consensus values.
• Multiple measurements by highly skilled personnel using validated methods.

However, the provided 510(k) summary does not detail how the ground truth for the master lot itself was established, focusing instead on how new lots of the Randox Aldolase Control are assigned values relative to that master lot.

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The Randox Immunoassay Speciality Control (II) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material for Calcitonin, Gastrin, and Procalcitonin to monitor the precision of the laboratory testing systems listed in the package insert. This device is for prescription use only.

Randox Immunoassay Speciality Control (II) is manufactured at three levels, Level 1, Level 2 and Level 3. Each control is prepared from human serum with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilised form in 5x1ml vials and require reconstitution with 1ml of distilled water. The analyte concentrations in each of the three levels have been chosen to span a range that includes the chemically significant or medical decision level(s). The analyte concentrations have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this device (Randox Immunoassay Speciality Control (II) Levels 1, 2 and 3), the primary "performance" is its stability and its ability to provide consistent "value assignments" for the analytes it controls. The acceptance criteria relate to the consistency of these assigned values.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Description: The "test set" in this context refers to the samples used for the value assignment study, which establishes the expected concentrations and ranges for the control material.
• Sample Size: For each analyte (Calcitonin, Gastrin, Procalcitonin), two vials of the control material were used. From these two vials, a total of 20 replicates were analyzed (5 replicates per vial, over 2 days).
• Data Provenance: The study was conducted at Randox Laboratories. The nature of the study (analyzing their own manufactured control material to establish values) implies it is an internal, prospective study aimed at characterizing the product. No specific country of origin for the underlying human serum in the control is stated beyond "human serum with added constituents of human origin." The added analytes (Calcitonin, Gastrin, Procalcitonin) have commercial origins as specified in the "Traceability" section (Sigma and Randox itself).

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

• Number of Experts: "A panel of experts" was used. The exact number is not explicitly stated, but the plural "experts" indicates more than one.
• Qualifications of Experts: The document states that these experts were involved in ensuring "the concentrations are clinically relevant for use in routine hospital laboratories." This implies they are likely clinical laboratory professionals, physicians, or scientists with expertise in immunoassay testing and clinical interpretation of analyte levels. Specific qualifications (e.g., years of experience, certifications) are not provided in the text.

4. Adjudication Method for the Test Set

• For Value Assignment: No explicit adjudication method (like 2+1 or 3+1 consensus) is described for the numerical value assignment. The assigned value is derived statistically as the mean of 20 replicates. The acceptance criterion for this is simply a %CV ≤ 15%.
• For Clinical Relevance: A "panel of experts" reviewed the analyte concentrations for clinical relevance. This implies a form of consensus-based "adjudication" for the appropriateness of the chosen concentration ranges, though the specific process (e.g., majority vote, discussion until agreement) is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This device is a quality control material, not a diagnostic device that humans interpret. Therefore, concepts like "human readers improving with AI vs. without AI assistance" are not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• A standalone performance study was implicitly done for the value assignment. The "device" in this context is the control material itself, and its performance (assigned values and stability) was determined using laboratory analyzers and protocols as described. There isn't an "algorithm" in the typical sense for this type of device; rather, it's about the analytical performance and characteristics of the control material when measured by standard laboratory equipment. The criteria (e.g., %CV) are quantitative measures of its performance.

7. Type of Ground Truth Used

• For Value Assignment: The "ground truth" for the analyte concentrations (Calcitonin, Gastrin, Procalcitonin) is established by replication and averaging on selected analyzers according to a defined protocol, meeting a specific precision criterion (%CV ≤ 15%). This is an analytical ground truth based on repeated measurements.
• For Clinical Relevance: The "ground truth" for the appropriateness of concentration ranges for clinical use is based on expert consensus (review by a panel of experts).

8. Sample Size for the Training Set

• This information is not explicitly provided. For a quality control material, there isn't a "training set" in the sense of machine learning. The focus is on characterizing the manufactured product. The "development" or "formulation" of the control material would involve a different set of experiments, but those aren't detailed here as a "training set." The materials used for value assignment (2 vials, 20 replicates) constitute the test set for its performance characteristics.

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

• As there isn't a "training set" described for this type of device, this question is not fully applicable. However, for the development of the control material itself (if we interpret "training set" loosely as the development phase leading up to the final product), the ground truth for its formulation and stability would have been established through a series of internal R&D experiments and analytical testing, likely guided by industry standards and regulatory expectations for control materials. The text only describes the validation/characterization of the final product.

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The Randox Maternal Controls Level 1, Level 2 and Level 3 are intended for in vitro diagnostic use in the quality control of Unconjugtaed Estriol and Total ß-Human Chorionic Gonadotrophin methods on clinical chemistry systems.
This in vitro diagnostic device is intended for prescription use only.

Randox Maternal Controls are manufactured at three levels, Level 1, Level 2 and Level 3. The analyte concentrations in each of the three levels have been chosen to span a range that includes the chemically significant or medical decision level(s). The analyte concentrations have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.

The provided text describes the Randox Maternal Controls Levels 1, 2 and 3 device and its substantial equivalence to a predicate device, focusing on its intended use as quality control material.

However, the provided text does not contain a detailed study proving the device meets specific acceptance criteria in the way a clinical study would for a diagnostic device. Instead, it describes the product's characteristics and the basis for its 510(k) clearance, which is primarily demonstrating substantial equivalence to an already legally marketed predicate device.

The "acceptance criteria" for a control material typically relate to its stability and performance characteristics, but the document doesn't explicitly list numerical target values for these. The closest information related to this is the stability testing methodology.

Here's an attempt to structure the information based on your request, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The provided document describes a stability study to determine the shelf-life of the controls. This is the primary "study" detailed in the submission.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Stability Test: Not explicitly stated in terms of number of individual control units tested. It refers to "a control stored at 37°C" and "the control stored at routine temperature," implying at least one sample was subjected to each condition.
• Data Provenance: Not specified, but the manufacturer is Randox Laboratories Limited, based in the United Kingdom. Given the context of a 510(k) submission, the data would have been generated as part of the device's development and testing by the manufacturer. It is a prospective study for the purpose of demonstrating stability characteristics.

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

• Number of Experts: Not explicitly stated, but referred to as "a panel of experts."
• Qualifications of Experts: The document states they reviewed analyte concentrations "to ensure that the concentrations are clinically relevant." No specific qualifications (e.g., "radiologist with 10 years of experience") are provided; however, based on the context of clinical chemistry controls, these would likely be clinical chemists, laboratory directors, or medical professionals with expertise in maternal serum screening.

4. Adjudication Method for the Test Set

• For the stability testing, the "adjudication method" is the comparison of percentage deviation against a 10% threshold. There's no human adjudication process described for the quantitative results of the stability test itself beyond this pre-defined criterion.
• For the clinical relevance of analyte concentrations, a "panel of experts" reviewed the concentrations, implying a consensus-based or expert opinion adjudication process, though the specific method (e.g., informal agreement, structured voting) is not detailed.

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 relevant for diagnostic imaging devices where human readers interpret images, often with and without AI assistance. This device is a quality control material for laboratory tests, not an imaging or interpretive diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable in the conventional sense. This device is a "control material," not an algorithm or an AI system. Its performance is evaluated biochemically/chemically, not through an algorithm's standalone interpretative capabilities. The "performance" relates to its stability and the accuracy of its assigned values for the analytes.

7. The Type of Ground Truth Used

• For Analyte Concentrations: Expert consensus/review regarding clinical relevance.
• For Stability: The "ground truth" for stability testing is the pre-defined target threshold of <10% deviation from a routinely stored control. The values of the analytes within the controls serve as the reference for precision and accuracy measurements, where the assigned values for the analytes themselves (provided in the product insert, though not detailed here) are the 'ground truth' or target values.

8. The Sample Size for the Training Set

• Not applicable. This device is a quality control material, not an AI/ML algorithm that requires a "training set."

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

• Not applicable. As above, there is no "training set" for this type of device.

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The Randox Microalbumin Liquid Controls are designed for use as assayed quality control materials for the quantitative determination of albumin in human urine. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

Randox Microalbumin Controls are manufactured at two levels, Level 1 and Level 2. They are single analyte controls made with human serum. The analyte concentrations in each control have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.

Acceptance Criteria and Device Performance Study for Randox Microalbumin Control Level 1 and Level 2 (Liquid)

1. Acceptance Criteria and Reported Device Performance

Note: The reported device performance for %CV and % Recovery Error is inferred from the statement "The CV% and % recovery error result should fall within the range shown below," indicating that the study results met these criteria. Specific numerical values for the reported performance were not provided in the document beyond meeting the acceptable range.

2. Sample Size and Data Provenance for Test Set

• Sample Size: 10 replicates were run for each control level (Level 1 and Level 2) on each of the following analyzers: Hitachi 717, Cobas Mira, RX Daytona, and Dimension.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It implies prospective testing conducted by Randox Laboratories.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document states: "The analyte concentrations in each control have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories."

• Number of Experts: A "panel of experts" (specific number not given).
• Qualifications of Experts: Not explicitly stated, but their role suggests expertise in clinical chemistry, laboratory medicine, or related fields relevant to albumin measurement in urine and quality control.

4. Adjudication Method for Test Set

The adjudication method is not explicitly stated. The "Target Value" for each control level was assigned based on "the average of all the results from the various analysers," and a range of +/- 20% was then applied to this average to define the "Acceptable Manufacturing Range." This suggests a statistical averaging approach rather than a specific expert adjudication method like 2+1 or 3+1 for individual results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a quality control material, not an AI-powered diagnostic device, so a study comparing human readers with and without AI assistance is not applicable.

6. Standalone Performance Study

Yes, a standalone study was performed. The "Summary of Value Assignment" describes the testing of the control material on various analyzers (Hitachi 717, Cobas Mira, RX Daytona, and Dimension) to determine a target value and confirm the acceptable manufacturing range, %CV, and % Recovery Error. This represents the performance of the control material itself, without human interpretation as part of the primary outcome.

7. Type of Ground Truth Used (Test Set)

The ground truth used for the test set (value assignment) appears to be derived from the average of quantitative measurements obtained from multiple established laboratory analyzers. This effectively serves as a consensus-based quantitative ground truth established through instrument performance on the control samples. Additionally, a "panel of experts" reviewed the assigned concentrations for clinical relevance.

8. Sample Size for Training Set

The document does not describe a distinct training set in the context of an algorithm or AI model development. This device is a chemical control material, not an AI diagnostic algorithm. Therefore, "training set" as understood in AI/ML is not applicable here. The "value assignment" phase is more akin to a calibration or characterization study.

9. How Ground Truth for Training Set Was Established

As noted above, there is no distinct "training set" in the context of AI. For the value assignment (which can be considered analogous to establishing the 'correct' values for the control material), the ground truth was established by:

• Running 10 replicates of the control material on four different widely-used laboratory analyzers (Hitachi 717, Cobas Mira, RX Daytona, and Dimension).
• Calculating the average of all results from these various analyzers to assign the "Target Value."
• Reviewing these concentrations by a "panel of experts" to ensure clinical relevance.

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