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510(k) Data Aggregation
(595 days)
Randox Laboratories Limited
The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cutoffs.
The Evidence MultiSTAT DOA Urine MultiPlex detects the following drugs at the following cut-offs:
| Analyte | Analyte in Cut Off Material | Cut-Off |
|---|---|---|
| Benzodiazepines I | Oxazepam | 200 ng/mL |
| Methamphetamine | S-(+)-Methamphetamine | 500 ng/mL |
| Noroxycodone | Noroxycodone | 100 ng/mL |
| Methadone | (±)-Methadone | 300 ng/mL |
The Evidence MultiSTAT DOA Urine MultiPlex provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and/or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) are the preferred confirmatory methods. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
For in vitro diagnostic use only.
The Evidence MultiSTAT analyzer is a benchtop fully automated Biochip Array System. It performs simultaneous detection of multiple analytes from a single sample. The core technology is the Randox Biochip, a solid-state device containing an array of discrete test regions containing immobilised antibodies specific to different Drugs of Abuse (DOA) compound classes, A competitive chemiluminescent immunoassay is used for the DOA assays with the drug in the specimen and drug labelled with horseradish peroxidase (HRP) being in direct competition for the antibody binding sites. Increased levels of drug in a specimen will lead to reduced binding of drug labelled with HRP and thus a reduction in chemiluminescence being emitted. The light signal generated from each of the test regions on the biochip is detected by a Charge Coupled Device (CCD) camera in the Evidence MultiSTAT system which, together with the analyzer software, is used to quantify the light output and produce meaningful results.
The immunoassay processes are performed automatically in a self-contained and sealed biochip cartridge, which holds the biochips, the reagents, wash buffer and other fluids required for the test to be conducted.
Evidence MultiSTAT assays employ a qualitative reporting method. Each test sample is assayed against the provided Cut Off material of known concentration, which is used to determine the classification of the samples based on the comparison of the signal output.
The Evidence MultiSTAT System uses Randox Biochip Technology and performs simultaneous detection of multiple analytes from a single sample, using the Evidence MultiSTAT Analyzer. The assays are diagnostic tests for qualitative determination of the parent molecule and metabolites of drugs in human urine. The qualitative tests are based on a cut off value for each analyte, as detailed in the table below.
The provided text describes a 510(k) premarket notification for the Randox Laboratories Limited, Evidence MultiSTAT DOA Urine Multiplex, and Evidence MultiSTAT device. This device is an in-vitro diagnostic (IVD) for the qualitative determination of drugs of abuse in human urine.
Crucially, the document does NOT describe the acceptance criteria or a study that proves the device meets those acceptance criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device.
The document details the device's intended use, methodology (competitive immunoassay), analytes tested, and cut-off values. It mentions that "Studies were performed to evaluate performance with regards to the precision, specificity, and accuracy of the candidate devices" but does not provide any specific data, acceptance criteria values, or details of these studies.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, specifically for an AI/ML context, because the provided text is for an IVD immunoassay device, not an AI/ML-powered medical device.
To answer your request based on the provided text, I can only state what is missing from the document related to AI/ML acceptance criteria and studies:
- No AI/ML Component: The device described is an immunoassay system (Evidence MultiSTAT DOA Urine Multiplex and Evidence MultiSTAT analyzer), which works based on chemical reactions and light detection, not artificial intelligence or machine learning.
- No Acceptance Criteria or Performance Data Provided: The document states that "Studies were performed to evaluate performance with regards to the precision, specificity, and accuracy of the candidate devices," but it does not provide any of the acceptance criteria themselves, nor the results of these studies. Therefore, no table of acceptance criteria vs. reported performance can be generated from this text.
- No Test Set Details: Since no performance study details are given, there is no information on:
- Sample size for the test set.
- Data provenance (country, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm-only) performance.
- Type of ground truth used.
- No Training Set Details: As this is not an AI/ML device, there is no mention of a training set or how ground truth for a training set would be established.
In summary, the provided FDA 510(k) clearance letter and summary pertain to a traditional in-vitro diagnostic immunoassay system and do not contain any information relevant to the acceptance criteria or performance studies of an AI/ML-powered medical device.
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(492 days)
Randox Laboratories Limited
The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cutoffs.
The Evidence MultiSTAT DOA Urine MultiPlex detects the following drugs at the following cut-offs:
| Analyte | Analyte in Cut Off Material | Cut-Off |
|---|---|---|
| Phenobarbital | Phenobarbital | 200 ng/ml |
| Tramadol | Tramadol | 200 ng/ml |
| Phencyclidine | Phencyclidine | 25 ng/ml |
| Buprenorphine | Norbuprenorphine | 5 ng/ml |
| 6-Acetylmorphine | 6-Acetylmorphine | 10 ng/ml |
The Evidence MultiSTAT DOA Urine MultiPlex provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and/or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) are the preferred confirmatory methods. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
For in vitro diagnostic use only.
The Evidence MultiSTAT analyzer is a benchtop fully automated Biochip Array System. It performs simultaneous detection of multiple analytes from a single sample. The core technology is the Randox Biochip, a solid-state device containing an array of discrete test regions containing immobilized antibodies specific to different Drugs of Abuse (DOA) compound classes. A competitive chemiluminescent immunoassay is used for the DOA assays with the drug in the specimen and drug labelled with horseradish peroxidase (HRP) being in direct competition for the antibody binding sites. Increased levels of drug in a specimen will lead to reduced binding of drug labelled with HRP and thus a reduction in chemiluminescence being emitted. The light signal generated from each of the test regions on the biochip is detected by a Charge Coupled Device (CCD) camera in the Evidence MultiSTAT system which, together with the analyzer software, is used to quantify the light output and produce meaningful results.
The immunoassay processes are performed automatically in a self-contained and sealed biochip cartridge, which holds the biochips, the reagents, wash buffer and other fluids required for the test to be conducted.
Evidence MultiSTAT assays employ a qualitative reporting method. Each test sample is assayed against the provided Cut Off material of known concentration, which is used to determine the classification of the samples based on the comparison of the signal output.
The Evidence MultiSTAT DOA Urine MultiPlex uses Randox Biochip Technology and performs simultaneous detection of multiple analytes from a single sample, using the Evidence MultiSTAT analyzer. The assays are diagnostic tests for qualitative determination of the parent molecule and metabolites of drugs in human urine. The qualitative tests are based on a cut off value for each analyte, as detailed in the table below.
I am sorry, but the provided text focuses on the FDA's 510(k) clearance for a device (Evidence MultiSTAT DOA Urine MultiPlex) and discusses its intended use, classification, and substantial equivalence to a predicate device. It briefly mentions that "Studies were performed to evaluate performance with regards to the precision, specificity, and accuracy of the candidate devices," and concludes that the device "raises no new issues of safety and effectiveness."
However, the text does not contain the detailed information required to answer your specific questions about:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How the ground truth for the training set was established.
This kind of detailed performance data and study methodology is typically found in the full 510(k) submission document, which is much more extensive than the FDA clearance letter and summary provided.
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(252 days)
RANDOX LABORATORIES LIMITED
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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(273 days)
RANDOX LABORATORIES LIMITED
For the quantitative in vitro determination of LDL-cholesterol concentration in human plasma and serum. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis and various liver and renal diseases.
This in vitro diagnostic device is intended for prescription use only.
The LDL Cholesterol kit assay consists of ready to use reagent solutions. CATALOGUE NUMBER: CH8312
R1. Enzyme Reagent 1 4 x 20 mL R2. Enzyme Reagent 2 4 x 9 mL
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
Device Name: Direct LDL Cholesterol (LDL)
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|---|
| Precision | Total CV % (within run, among run, among day) | Generally expected to be low for clinical assays, with specific targets often dependent on concentration levels. | QC 1 (92.0 mg/dl): 5.9% total CV |
| QC 2 (135.9 mg/dl): 4.6% total CV | |||
| QC 3 (186.7 mg/dl): 4.4% total CV | |||
| Serum pool 1 (65.0 mg/dl): 5.9% total CV | |||
| Serum pool 2 (154.0 mg/dl): 5.0% total CV | |||
| Serum pool 3 (200.1 mg/dl): 5.0% total CV | |||
| Serum pool 4 (343.7 mg/dl): 5.3% total CV | |||
| Linearity/Reportable Range | Linear Regression Correlation Coefficient (r) | Close to 1.0 (indicating a strong linear relationship) | r = 0.997 |
| Reportable Range | Defined range where results are linear. | 21 - 740 mg/dl | |
| Detection Limit | Limit of Blank (LoB) | Very low, ideally close to zero, to ensure no signal from blank. | 1.94 mg/dl |
| Limit of Detection (LoD) | Low enough to reliably detect the analyte. | 3.19 mg/dl | |
| Limit of Quantitation (LoQ) | Low enough for precise and accurate quantification at low concentrations (typically ≤20% imprecision). | 16.1 mg/dl (with ≤20% imprecision) | |
| Analytical Specificity | Interference (% of Control) | % of Control ± 10% for potential interferents at specified concentrations. | Hemoglobin: No significant interference up to 1000mg/dl. |
| Total Bilirubin: No significant interference up to 60mg/dl. | |||
| Conjugate Bilirubin: No significant interference up to 60mg/dl. | |||
| Triglycerides: No significant interference up to 500mg/dl. | |||
| Intralipid®: No significant interference up to 500mg/dl. | |||
| Ascorbic Acid: No significant interference up to 6mg/dl. | |||
| Method Comparison | Linear Regression Correlation Coefficient (r) | Close to 1.0 when compared to a predicate device, indicating substantial equivalence. | r = 0.998 (compared to predicate device) |
| Matrix Comparison | Linear Regression Correlation Coefficient (r) | Close to 1.0 when comparing serum and lithium heparin plasma, indicating equivalent performance across matrices. | r = 0.998 (serum vs. lithium heparin plasma) |
| Traceability | Conformance to reference materials/standards | Traceable to an internal master reference material. Not certified by CRMLN (stated as a disclaimer in labeling). | Traceable to an internal master reference. Labeling states "device has not been certified by the CRMLN." |
Study Details
- Sample size used for the test set and the data provenance:
- Precision (Analytical Performance): 80 determinations for each of 7 pools/QC levels (total of 560 determinations). The samples included control material and "unaltered human serum samples that were spiked with LDL cholesterol concentrations or diluted to achieve concentrations based on established ranges" (e.g.,
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(181 days)
RANDOX LABORATORIES LIMITED
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:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Precision/Reproducibility: Repeatability and intermediate precision within acceptable limits. | Serum Pool 1 (Mean 0.65 mg/dl): Within Run CV: 3.0%, Among Run CV: 1.6%, Among Day CV: 2.4%, Total CV: 4.2% |
| Serum Pool 2 (Mean 2.31 mg/dl): Within Run CV: 3.1%, Among Run CV: 0.0%, Among Day CV: Not reported (likely very low, as next cell is blank), Total CV: 3.1% | |
| Serum Pool 4 (Mean 8.41 mg/dl): Within Run CV: 1.5%, Among Run CV: 0.8%, Among Day CV: 0.9%, Total CV: 1.9% | |
| Linearity/Reportable Range: Linear function to analyte concentration (deviation from linearity 12.6 mg/dl). | |
| Detection Limit (LoQ): Lowest concentration detectable with ≤20% CV imprecision. | LoD: 0.064 mg/dl |
| LoB: 0.006 mg/dl | |
| LoQ: 0.133 mg/dl (confirmed to be ≤20% CV imprecision). | |
| Analytical Specificity/Interference: No significant interference from common interferents at specified levels (Ac-ceptance Criteria: % of Control ± 10%). | Haemoglobin: No significant interference up to 1000 mg/dl |
| Triglycerides: No significant interference up to 750 mg/dl | |
| Intralipid®: No significant interference up to 1000 mg/dl | |
| Ascorbic Acid: No significant interference up to 25 mg/dl (This suggests the results fell within ± 10% of the control). | |
| Method Comparison with Predicate Device: Strong correlation with the predicate device. | Correlation Coefficient (r): 0.997 (for 103 serum patient samples spanning 0.123-12.46 mg/dl). |
| Regression Equation: Y = 1.01x + 0.01. | |
| Matrix Comparison: Agreement between serum and lithium heparin plasma samples. | Correlation Coefficient (r): 1.00 (for a minimum of 40 matched patient sample pairs spanning 0.091-12.48 mg/dl). |
| Regression Equation: Y = 0.99x + 0.01. |
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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(162 days)
RANDOX LABORATORIES LIMITED
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
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Linearity/Reportable Range | Deviation from linearity less than 5% across the analytical range. | Linear regression correlation (r) = 0.9999 for the range 0.21 – 26.3 mg/dL. The reported range is 0.21 – 26.3 mg/dL. (Implies linearity within this range was met). |
| Limit of Detection (LoD) | Not explicitly stated as an acceptance criterion for the study, but determined. | LoD = 0.08 mg/dL (based on 240 determinations, 4 low-level samples). |
| Limit of Blank (LoB) | Not explicitly stated as an acceptance criterion for the study, but determined. | LoB = 0.06 mg/dL. |
| Limit of Quantitation (LoQ) | Not explicitly stated as an acceptance criterion for the study, but determined. | LoQ = 0.21 mg/dL (lowest concentration at which precision is still met). |
| Analytical Specificity (Interference) | Recovery within ±10% of the initial value of Total Bilirubin concentration (0.99 mg/dL and 15.03 mg/dL) for specified interferents. | Haemoglobin: No significant interference up to 1000 mg/dL. |
| Triglycerides: No significant interference up to 2000 mg/dL. | ||
| Intralipid®: No significant interference up to 1000 mg/dL. | ||
| Ascorbic Acid: No significant interference up to 25.0 mg/dL. (All met the ±10% recovery implicitly). | ||
| Method Comparison (with predicate device) | Not explicitly stated as an acceptance criterion (e.g., a specific agreement or bias limit), but "substantial equivalence" is the overall goal. | Linear regression equation: Y = 1.02x - 0.02. Correlation coefficient (r) = 0.9999. (This high correlation supports substantial equivalence). |
| Matrix Comparison (Serum vs. Plasma) | Not explicitly stated as an acceptance criterion, but the goal is for method accuracy with plasma to be equivalent to serum and no interference. | Linear regression equation: Y = 0.99x + 0.04. Correlation coefficient (r) = 0.9999. (This high correlation suggests equivalence). |
| Expected/Reference Values | Verified using NCCLS C28-A3 guidelines; all values from 30 normal donors fall within the quoted range for healthy individuals (0.3 – 1.2 mg/dL). | All values from the 30 normal donors tested on the RX Daytona plus fell within the quoted ranges for Healthy Individuals (0.3 – 1.2 mg/dL). |
| Precision/Reproducibility | Not explicitly stated as an acceptance criterion (e.g., a maximum CV%), but detailed results are provided. | See Table 2 (page 6) for detailed SD and CV values across different concentrations for Within Run, Among Run, Among Day, and Total precision. For example, for a mean of 25.0 mg/dL, Total CV was 1.7%; for 0.3 mg/dL, Total CV was 7.4%. These values are typically considered acceptable for clinical assays. |
Study Details
-
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.
-
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.
-
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.
-
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.
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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.
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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.
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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.
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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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(132 days)
Randox Laboratories Limited
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.
| Performance Characteristic | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | Not explicitly stated as a single numerical criterion. Evaluated consistent with C.L.S.I documents EP5-A2. Implied goal is acceptable variability across runs, days, and total. | Lot 1 (RX Daytona Plus): |
- 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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(236 days)
RANDOX LABORATORIES LIMITED
The Liquid Assayed Chemistry Control Premium Plus Levels 1, 2 and 3 are assayed quality control materials intended for in vitro diagnostic use in the quality control of diagnostic assays. This material can be used to monitor the accuracy or reproducibility of analytes listed in the package insert. This device is for prescription use only.
The Liquid Assayed Chemistry Control Premium Plus is human liquid sera to which purified biochemical material, chemicals, drugs, preservatives and stabilizers have been added. The material is supplied at levels 1, 2 and 3. Each 5 ml vial of liquid serum is stored at -20°C to -70°C. Each level is supplied in a 12 by 5ml vials.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria.
The document is a 510(k) premarket notification for a medical device called "Liquid Assayed Chemistry Control Premium Plus Level 1, 2 and 3". It describes the device, its intended use, compares it to a predicate device, and includes summaries of stability studies (thawed open vial stability and shelf-life study) and value assignment.
Here's what I can extract, focusing on "acceptance criteria" as applied in the context of the control material stability studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|---|
| Thawed Open Vial Stability | All acceptance criteria for all analytes | All acceptance criteria were met for all analytes. |
| Shelf-life Study (Real Time Testing) | All acceptance criteria for all analytes | All acceptance criteria were met for all analytes. |
Important Note: The document states that "All acceptance criteria were met for all the analytes" for both stability studies, but it does not explicitly list the specific numerical or qualitative acceptance criteria themselves. It only mentions that the percentage deviation was calculated for the shelf-life study.
Regarding the other requested information, there is no data in the provided text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the sample size for the stability studies or value assignment process.
- It does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. 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 information is not applicable as the device is a quality control material, not an AI or diagnostic imaging device that requires interpretation by experts for ground truth establishment in a test set.
- For value assignment, it mentions "a number of external laboratories" and "in-house testing," but does not specify the number or qualifications of personnel involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective data, which is not the primary focus of testing a quality control material.
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. The device is a quality control material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The device is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the stability studies, the "ground truth" or reference is assumed to be the established values or expected performance of the control material under specific conditions, compared to its performance over time. The document mentions "statistical analysis including the mean, SD and % CV were calculated" and that "an assigned value is calculated from the target mean specific value." This implies a reference standard derived from analytical measurements rather than expert consensus or pathology.
8. The sample size for the training set
- This information is not applicable as the device is a quality control material, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- This information is not applicable.
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(41 days)
RANDOX LABORATORIES LIMITED
The Aldolase Calibration Serum is intended for in vitro diagnostic use in the calibration of Aldolase on the Randox RX Daytona and Beckman Coulter AU640 systems. This device is for prescription use only.
The Aldolase Calibrator is supplied in a kit containing 3x1ml vial of lyophilized serum is reconstituted with exactly 1 ml of distilled water and is stable for 5 days when reconstituted and stored at +2°C to +8° C.
The base matrix used for the manufacture of the Aldolase Calibration Serum is Human Serum with added chemicals.
Human source material from which this product has been derived and has been tested at the donor level for the Human Immunodeficiency Virus (HIV1 & HIV2) antibody, Hepatitis B surface antigen (HbsAg) and the Hepatitis C virus (HCV) antibody and were found to be non-reactive based on FDA approved methods.
However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly.
The provided document describes the Randox Aldolase Calibration Serum. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Open Vial Stability | Percentage deviation of reconstituted to fresh should be ≤5%. | Current open vial studies support a reconstituted claim of 5 days when stored at +2°C to +8°C. |
| Real Time Testing (Shelf Life) | Calibrator recovery for routinely stored compared to ultra-frozen should be within +/-5% deviation and all controls should be within range. | Current Real Time studies support a 2-year shelf life. |
| Value Assignment (Precision) | Precision measured by the CV should be less than or equal to 3%. | RX Daytona: CV = 2.2% |
| Beckman Coulter AU640: CV = 1.8% |
2. Sample size used for the test set and the data provenance
- Open Vial Stability: The document states "Samples were reconstituted and stored...and tested for Aldolase." It does not specify the exact number of samples (vials) used, but it implies a sufficient number for testing the 7-day stability.
- Real Time Testing: The document refers to "routinely stored calibrators are compared to the ultra frozen calibrators at various time points." It doesn't specify the exact sample size or number of comparisons.
- Value Assignment: For the precision study, N=10 replicates were performed for each instrument (RX Daytona and Beckman Coulter AU640).
- Data Provenance: The studies were conducted by Randox Laboratories, Ltd., which is based in the United Kingdom. The studies appear to be prospective as they are verifying and validating the performance characteristics of the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a calibration serum, not a diagnostic imaging or AI-driven interpretative device that requires expert review for ground truth. The "ground truth" here is the assigned value of the calibrator, derived from established reference calibrators or consensus values.
4. Adjudication method for the test set
This section is not applicable for the reasons stated above. Adjudication is not relevant for the performance evaluation of a calibration serum.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools that assist human readers, which is not the nature of this calibration serum.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a calibration serum used in conjunction with analytical instruments (Randox RX Daytona and Beckman Coulter AU640) for calibrating aldolase assays. It is not an algorithm or AI system. Its performance is demonstrated through its ability to provide stable and precise values according to established measurement principles, not as a standalone interpretive algorithm.
7. The type of ground truth used
The ground truth for the Randox Aldolase Calibration Serum values is based on:
- Nested testing against a master lot calibrator: The master lot's value assignment was derived using a Randox calibrator with established consensus values or an International Reference Preparation (IRP) where available and applicable. This implies traceability to primary or secondary reference materials.
- For the precision study, the "ground truth" (or target value) for the Aldolase concentration is established through this hierarchical value assignment process.
8. The sample size for the training set
This section is not applicable. This is a calibration serum, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable as there is no training set for this device.
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(79 days)
RANDOX LABORATORIES LIMITED
This product is intended for in vitro diagnostic use as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert.
Randox Immunoassay Premium Plus Controls are manufactured at three levels, Level 1, Level 2 and Level 3. The materials are supplied as Level 1, Level 2 , Level 3 and a Tri-Level configuration. Each 5 ml vial of lyophilized serum is reconstituted with exactly 5 ml of distilled water at +20 to 25° C.
The base matrix used for the manufacture of Randox Immunoassay Premium Plus Controls is Human Serum with added chemicals.
Human source material from which this product has been derived and has been tested at the donor level for the Human Immunodeficiency Virus (HIV1 & HIV2) antibody, Hepatitis B surface antigen (HbsAg) and the Hepatitis C virus (HCV) antibody and were found to be non-reactive based on FDA approved methods.
However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordinaly.
This document describes the stability studies conducted for the Randox Immunoassay Premium Plus Controls Levels 1, 2, and 3, and the Immunoassay Premium Plus Tri-Level Control. These studies establish the acceptance criteria for various stability conditions and demonstrate the device's performance against these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Study Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Open Vial Stability (General) | Percentage deviation of reconstituted to fresh should be ≤10%. | All analytes (excluding C-Peptide, Thyroglobulin, ACTH, and PTH) in all control levels (1, 2, 3, and Tri-Level) passed the stability test at Day 7 when stored at +2 to +8°C. |
| Open Vial Stability (C-Peptide) | Percentage deviation of reconstituted to fresh should be ≤10%. | C-Peptide in all control levels (1, 2, 3, and Tri-Level) passed the stability test at Day 1 when stored at +2 to +8°C. |
| Open Vial Stability (ACTH, Thyroglobulin, PTH) | Percentage deviation of reconstituted to fresh should be ≤10%. | ACTH, Thyroglobulin, and Parathyroid Hormone (PTH) in all control levels (1, 2, 3, and Tri-Level) passed the stability test at 4 hours when stored at +2 to +8°C. |
| Frozen Stability | Percentage deviation of reconstituted to fresh should be ≤10%. (No claim for ACTH, Aldosterone, C-Peptide) | All analytes (excluding ACTH, Aldosterone, and C-Peptide) in all control levels (1, 2, 3, and Tri-Level) passed the stability test after 4 weeks (28 days) when stored at -18 to -24°C. |
| Accelerated Stability | Percentage deviation to fresh should be ≤10%. | All analytes in all control levels (1, 2, 3, and Tri-Level) passed the accelerated stability test at Week 4 (after storage at elevated temperatures: 28-32 °C, 35-39 °C, and 43-47 °C). This supported a predicted shelf life of 3 years. |
| Real Time Stability | Percentage deviation to controls stored at the routine temperature should be ≤10%. | Current Real Time studies (monitoring controls stored at -75 to -90°C against controls stored at +2 to +8°C at various timepoints) support a 3-year shelf life for all control levels (1, 2, 3, and Tri-Level). The document explicitly states "Current Real Time studies support a 3 year shelf life," implying that the acceptance criteria of ≤10% deviation were met. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For open vial stability, frozen stability, and real-time/accelerated stability, the studies were conducted using a "set" of Immunoassay Premium Plus Controls levels 1, 2 & 3.
- Specific lot numbers were used: 972EC, 974EC, 977EC for the individual levels and combination for the Tri-Level control for open vial and frozen stability.
- For accelerated and real-time stability, lot numbers 852EC/941EC, 854EC/943EC, and 857EC/946EC were used.
- The document does not specify the number of individual vials or replicates tested within each lot for these stability studies.
- Data Provenance: The studies were conducted by Randox Laboratories Limited, based in Crumlin, County Antrim, United Kingdom. The data is prospective, as these are stability studies conducted to support the device's shelf life and claims.
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 quality control material, not an imaging or diagnostic algorithm that relies on expert interpretation of images or clinical data. Therefore, the concept of "experts" establishing a ground truth for a test set in the conventional sense (e.g., radiologists, pathologists) does not directly apply here.
For the Value Assignment (Section 9), which can be considered analogous to establishing "ground truth" for the analyte concentrations within the control material:
- Number of Participants: "Each batch of Immunoassay Premium Plus is submitted to a number of external laboratories" and/or by in-house testing. The exact number of external laboratories is not specified.
- Qualifications of Participants: The document does not specify the qualifications of the personnel or laboratories involved in the value assignment process, beyond stating they are "external laboratories" and "in-house testing." However, for diagnostic control materials, these would typically be certified clinical reference laboratories or laboratories adhering to recognized quality standards for analytical testing.
4. Adjudication Method for the Test Set
For Value Assignment (Section 9):
- Method: Statistical analysis, including the mean, SD, and %CV, were calculated from the results obtained by these laboratories. An assigned value is derived from the mean specific value, and an analyte-specific percentage range is applied. This suggests a form of consensus-based adjudication among the participating laboratories, where the mean value plays a central role.
For Stability Studies:
- Method: The adjudication method for stability studies is direct comparison against predefined acceptance criteria (percentage deviation of ≤10% from fresh or routine controls). This is a direct analytical measurement comparison rather than expert consensus on individual results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study (MRMC) is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret cases, and the study aims to quantify the effect of an AI tool on their performance. The Randox Immunoassay Premium Plus Controls are in vitro diagnostic quality control materials, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not applicable.
6. Standalone Performance Study
Yes, the stability studies (open vial, frozen, accelerated, and real-time stability) described are standalone assessments of the device's performance (specifically its stability) under various conditions. These studies rigorously evaluate the control material itself without human intervention in the performance measurement, beyond handling according to instructions. The value assignment also represents a standalone assessment of the control's intended values.
7. Type of Ground Truth Used
- For Stability Studies: The "ground truth" for stability is established through reference measurements against freshly reconstituted or routinely stored control materials. The acceptance criterion is a predefined percentage deviation (≤10%) from these reference measurements.
- For Value Assignment: The "ground truth" for the assigned analyte values is established by a consensus of results obtained from multiple external laboratories and/or in-house testing, applying statistical analysis (mean, SD, %CV).
8. Sample Size for the Training Set
This document does not describe a "training set" in the context of machine learning. The device is a physical in vitro diagnostic control material, not a software algorithm that is "trained" on data. The manufacturing process and quality control procedures ensure the consistency and performance of the product.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no "training set" for this device in the conventional sense. The "ground truth" for the assigned values of the control material (which might be analogous to what a "training set" would establish for an AI model) is established through the consensus of results from multiple laboratories and statistical analysis as described in Section 9 of the document.
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