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The Direct Bilirubin test system is a device intended for the quantitative in vitro determination of Direct Bilirubin in serum and plasma. Bilirubin measurements can be used in the diagnosis and treatment of liver, hematological and metabolic disorders including hepatitis and gall bladder block.

This device is for prescription use only.

The Randox Direct Bilirubin kit consists of ready to use reagent solutions.

CATALOGUE NUMBER: BR8308 COMPONENTS: R1. 4 x 20ml, R2. 4 x 8ml

REAGENT COMPOSITION

R1. Direct Bilirubin RI Tartrate buffer, pH2.9 Detergent Antimicrobials and Preservatives Inhibitors Initial Concentration of Solutions 0.1 mol/L
R2. Direct Bilirubin R2 Phosphate buffer, pH 7.0 Sodium Metavanadate Initial Concentration of Solutions 10 mmol/L 4 mmol/L

Here's a breakdown of the acceptance criteria and the study details for the Randox Direct Bilirubin device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance characteristics but does not explicitly state "acceptance criteria" in a tabulated format derived from a regulatory body or a specific standard with pass/fail thresholds. Instead, it presents the results of various analytical performance studies. However, some sections imply acceptance criteria through their phrasing (e.g., "deviation from linearity is less than 5%" for linearity, "no significant interference" for specificity, and "≤20% CV imprecision" for LoQ).

Here's an interpretation of implied acceptance criteria and reported performance:

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

• Precision/Reproducibility:
  • Sample Size: Not explicitly stated as a number of samples but rather as "control material and unaltered human serum samples" divided into pools (Pool 1, 2, 4) and tested over 20 non-consecutive days with 2 replicates per run. This implies a significant number of measurements for each pool.
  • Data Provenance: "unaltered human serum samples." The country of origin is not specified, but the submission is from the UK. The study is prospective in nature (testing conducted for the device).
• Linearity/Assay Reportable Range:
  • Sample Size: Samples prepared at 11 levels. Each level run in replicates of five.
  • Data Provenance: Not specified, but samples were prepared to cover a range of analyte concentrations. Prospective.
• Detection Limit:
  • Sample Size: 240 determinations (for LoD) with 4 low-level samples.
  • Data Provenance: Not specified. Prospective.
• Analytical Specificity/Interference:
  • Sample Size: Not explicitly stated as a number of samples, but "the analytes detailed below were tested up to the levels indicated at Bilirubin concentrations of 0.14mg/dl and 5.03mg/dl."
  • Data Provenance: Not specified. Prospective.
• Method Comparison with Predicate Device:
  • Sample Size: 103 serum patient samples.
  • Data Provenance: "patient samples." The country of origin is not specified. Likely retrospective, as existing patient samples were used, but the testing itself was prospective.
• Matrix Comparison:
  • Sample Size: A minimum of 40 matched patient sample pairs.
  • Data Provenance: "Patient samples." The country of origin is not specified. Likely retrospective, as existing patient samples were used, but the testing itself was prospective.

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

This device is an in vitro diagnostic (IVD) test for quantitative determination of Direct Bilirubin. The "ground truth" for such devices is typically established through reference methods or established predicate devices, not through expert consensus in the same way an imaging or pathology AI might.

• Precision, Linearity, Detection Limit, Specificity: Ground truth is inherent in the analytical methods themselves (e.g., gravimetric dilutions for linearity, spiked samples, controlled interferent concentrations). No external experts are mentioned.
• Method Comparison and Matrix Comparison: The ground truth for these studies is the measurement obtained by the predicate device (Wako Direct Bilirubin V, K053132) or the matched serum/plasma results themselves. No external experts are described as establishing this "ground truth."

4. Adjudication Method for the Test Set

Not applicable for this type of IVD device. Adjudication is typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies.

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 automated in vitro diagnostic test, not an AI-assisted human reading device.

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 Direct Bilirubin assay system, an automated IVD device. The results reported are directly from the instrument measurements.

7. The Type of Ground Truth Used

• For analytical performance studies (Precision, Linearity, Detection Limit, Specificity): The 'ground truth' is established through controlled laboratory preparations (e.g., known concentrations of analytes, spiked samples, dilutions) and comparisons to established analytical methods as described in CLSI guidelines.
• For method comparison: The 'ground truth' is the predicate FDA-cleared device (Wako Direct Bilirubin V, K053132).
• For matrix comparison: The 'ground truth' is the serum sample measurement when comparing to lithium heparin plasma.

8. The Sample Size for the Training Set

Not applicable. This is a chemical assay, not a machine learning model that requires a training set. The "development" or "optimization" phase of such an assay would involve internal R&D, but it's not a "training set" in the context of AI/ML.

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

Not applicable. There is no training set for an IVD chemical assay as described here. Parameter settings and reagent formulations are determined through standard chemical and biochemical R&D processes, not through machine learning ground truth establishment.

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For the quantitative in vitro determination of Total Bilirubin for serum and plasma. Total Bilirubin measurements are used in the diagnosis and treatment of hemolytic, biliary and liver disorders, including hepatitis and cirrhosis.

This in vitro diagnostic device is intended for prescription use only.

The Total Bilirubin kit assay consists of ready to use reagent solutions.

CATALOGUE NUMBER: BR8307

R1. Total Bilirubin R1 4 x 20 mL
R2. Total Bilirubin R2 4 x 8 mL

REAGENT COMPOSITION

Contents Initial Concentration of Solutions
R1. Total Bilirubin R1
Citrate buffer, pH2.9 0.1 mol/L
Detergent 0.9%
Antimicrobial
R2. Total Bilirubin R2
Phosphate buffer, pH 7.0 10 mmol/L
Sodium Metavanadate 4 mmol/L

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 an analysis of the provided text, focusing on the acceptance criteria and the studies conducted to meet them for the Total Bilirubin (T BIL) device.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Precision/Reproducibility: 80 determinations per sample type (LIN Pool, LOQ Pool, QC 1, QC 2, Serum Pool 1-4) across two lots, two RX Daytona plus systems, over 20 non-consecutive days with 2 replicates per run. Data provenance is not specified, but the study design suggests prospective testing of control materials and human serum samples (spiked or diluted).
   • Linearity/Assay Reportable Range: 11 levels, each run in replicates of five across two lots of reagent on one RX Daytona plus system. Data provenance is not specified.
   • Detection Limit: 240 determinations (for LoD) using 4 low-level samples. Data provenance is not specified.
   • Analytical Specificity (Interference): Not explicitly stated how many samples or replicates per interferent. Samples were spiked with interferents and compared to control samples. Data provenance is not specified.
   • Method Comparison: 106 serum patient samples spanning 0.21 to 26.9 mg/dL. Data provenance is not specified, but these are "patient samples," suggesting retrospective or prospective clinical samples.
   • Matrix Comparison: A minimum of 40 matched patient sample pairs (serum and lithium heparin plasma). Data provenance is not specified, but these are "patient samples," suggesting retrospective or prospective clinical samples.
   • Expected values/Reference range: Human serum from 30 normal donors. Data provenance is not specified. The study was prospective in nature, testing new samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • This is an in vitro diagnostic device for quantitative chemical analysis. The "ground truth" is established by the analytical reference methods or established values of control materials, or comparison to a predicate device. There is no mention of human experts defining ground truth through consensus in the way a radiological study might. For the method comparison, the predicate device (Siemens Healthcare Diagnostic Inc, Total Bilirubin 2 reagent, K063845) serves as the reference, which itself would have undergone rigorous analytical validation.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. This is an analytical chemistry device, not an imaging device requiring human adjudicated interpretations. The performance is assessed by quantitative analytical metrics.

4. 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 analytical chemistry device, not an AI-assisted diagnostic tool involving human readers.

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

   • This is an in vitro diagnostic assay, which by nature operates "standalone" in terms of measurement. The results are then interpreted by a clinician, but the device itself generates a quantitative result without human-in-the-loop performance influencing the measurement. Performance studies like precision, linearity, and analytical specificity are inherently "standalone" evaluations of the device's analytical function.

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

   • Reference Methods/Materials: For linearity and precision, the ground truth is based on gravimetrically prepared samples, known concentrations of control materials, or dilutions with expected values.
   • Predicate Device: For method comparison, the results from the legally marketed predicate device (Siemens Healthcare Diagnostic Inc, Total Bilirubin 2 reagent, K063845) serve as the comparative ground truth.
   • Literature/Guidelines: For reference range verification, established normal ranges from scientific literature (e.g., "Tietz Clinical Guide to laboratory Tests") and guidelines (NCCLS C28-A3) are used.

7. The sample size for the training set

   • Not applicable. This is an analytical chemistry device, not a machine learning model that requires a training set.

8. 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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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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For the quantitative in vitro determination of Triglycerides in serum. Triglyceride measurements are used in the diagnosis and treatment of diseases involving lipid metabolism and various endocrine disorders e.g Diabetes mellitus, nephrosis and liver obstruction

This in vitro diagnostic device is intended for prescription use only.

The Randox Triglycerides kit assay consists of ready to use reagent solutions.

Here's a breakdown of the acceptance criteria and the study information for the Triglycerides (TRIGS) device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" for the entire device's performance followed by a direct comparison in a single table, but rather describes various performance characteristics and their findings. I will construct a table based on the individual performance criteria and the results presented.

• Sensitivity Pool (13.3 mg/dl): Total CV 13.4%
• Serum Pool 1 (96.4 mg/dl): Total CV 2.1%
• QC 1 (96.5 mg/dl): Total CV 2.3%
• Patient Pool 2 (104 mg/dl): Total CV 2.5%
• Patient Pool 1 (117 mg/dl): Total CV 2.5%
• Serum Pool 2 (237 mg/dl): Total CV 2.1%
• CAL (240 mg/dl): Total CV 2.0%
• QC 2 (259 mg/dl): Total CV 1.5%
• Serum Pool 3 (326 mg/dl): Total CV 1.6%

Lot 2 (RX Daytona Plus):

• Sensitivity Pool (17.7 mg/dl): Total CV 11.6%
• 801UN QC 2 (97.3 mg/dl): Total CV 3.2%
• Serum Pool 1 (111 mg/dl): Total CV 3.6%
• 832UE CAL (235 mg/dl): Total CV 3.0%
• Serum Pool 2 (252 mg/dl): Total CV 2.6%
• 587UE QC 3 (265 mg/dl): Total CV 2.5%
• Serum Pool 3 (326 mg/dl): Total CV 3.7%
• Serum Pool 4 (514 mg/dl): Total CV 2.8% |
  | Linearity/Assay Reportable Range | Deviation from linearity less than 5%. | Linearity: Slope 0.96, Intercept 3.30, r = 1.000.
  Reportable Range: 12.4 – 1000 mg/dl. (The linearity study covered up to approximately 1000 mg/dl, and the device has an auto-dilution feature for samples >1000 mg/dL). |
  | Detection Limit | Not explicitly stated as acceptance criteria, but rather defined properties. | LoD: 3.96 mg/dl (based on 240 determinations, 4 low-level samples)
  LoB: 2.65 mg/dl
  LoQ: 12.4 mg/dl (lowest concentration at which precision is met) |
  | Analytical Specificity (Interference) | Recovery within ±10% of the initial value of Triglycerides concentration of 150mg/dL and 496mg/dL. | Hemoglobin: No significant interference up to 750mg/dL
  Total Bilirubin: No significant interference up to 60mg/dL
  Conjugate Bilirubin: No significant interference up to 60mg/dL
  Ascorbic Acid: No significant interference up to 3.0mg/dL |
  | Method Comparison with Predicate Device | Not explicitly stated as a single numeric criterion for the regression, but the goal is "substantially equivalent" to the predicate. Implied acceptable correlation (r) and agreement (slope, intercept). | Comparison: Y = 0.97x + 1.22
  Correlation coefficient: r = 0.999 (This indicates a very strong positive correlation) |

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

• Precision/Reproducibility:
  • Test Set: Serum-based control material and unaltered human serum samples (some spiked or diluted). Specific numbers of individual patient samples beyond "Pool 1, Pool 2, Pool 3, Pool 4" are not given. For each sample type, 2 replicates per run were performed, twice daily for 20 non-consecutive days, using 2 reagent lots and 2 systems.
  • Data Provenance: Not explicitly stated, but implies laboratory testing with control materials and human serum samples. Given the manufacturer is based in the UK, it's likely the testing was done there, but this is not confirmed. It is a prospective study design for precision.
• Linearity:
  • Test Set: 11 levels prepared from low and high serum pools, each run in replicates of five.
  • Data Provenance: Not explicitly stated, but implies laboratory testing with serum pools. Prospective study design.
• Detection Limit:
  • Test Set: 240 determinations were made, including 4 low-level samples, to determine LoD, LoB, and LoQ.
  • Data Provenance: Not explicitly stated, implies laboratory testing. Prospective study design.
• Analytical Specificity (Interference):
  • Test Set: Spiked interferent samples with corresponding control solutions. Specific number of samples not provided. Triglycerides concentrations of 150 mg/dL and 496 mg/dL were examined.
  • Data Provenance: Not explicitly stated, implies laboratory testing. Prospective study design.
• Method Comparison:
  • Test Set: 109 serum patient samples spanning the range 14.2 to 986 mg/dl. Each tested in singlicate.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but states "serum patient samples." Implies retrospective collection of samples or prospective collection for this study.

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

This device (Triglycerides assay) is an in-vitro diagnostic device for quantitative chemical analysis. The "ground truth" for these types of devices is established through analytical reference methods or highly characterized reference materials, not typically by expert consensus of human readers.

• No mention of human experts or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

Not applicable for this type of quantitative analytical assay. Adjudication is typically used in image-based diagnostic studies involving human interpretation.

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 involves assessing the performance of human readers, sometimes with and without AI assistance, and is not relevant for a quantitative chemical assay.

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

Yes, the studies described (precision, linearity, detection limit, analytical specificity, method comparison) represent the standalone performance of the device/system (RX Daytona plus analyzer with Randox Triglycerides reagent) without human intervention in the analytical measurement process beyond sample loading and general operation.

7. The Type of Ground Truth Used

• Precision/Reproducibility, Linearity, Detection Limit, Analytical Specificity: The "ground truth" or reference for these studies refers to the true concentration of triglycerides in the samples (control materials, spiked samples, diluted samples) as determined by a highly accurate method or known values of reference materials.
• Method Comparison: The "ground truth" is the results obtained by a legally marketed predicate device (Randox Triglyceride Assay, K923508). For calibrators within the system, Randox Calibration Serum Level 3 is stated to be traceable to the Triglycerides reference method ID-GC/MS. This indicates a high-accuracy chemical method is the ultimate ground truth for calibration.

8. The Sample Size for the Training Set

This document describes a medical device (an in-vitro diagnostic reagent/system) for which "training sets" are not typically applicable in the same way as for AI/machine learning algorithms. The device's performance characteristics are inherent to its chemical formulation and the analytical instrument. There is no mention of a "training set" for an algorithm.

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

Not applicable, as there is no specific "training set" for an algorithm mentioned in the context of this device.

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