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510(k) Data Aggregation
(181 days)
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 < 5%). | Linearity: 0.1 - 12.6 mg/dl. Slope: 1.01, Intercept: -0.07, r: 0.9995, Syx: 0.10. Reportable Range: 0.1 - 12.6 mg/dl (with auto-dilution for >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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(146 days)
The Stanbio Direct Bilirubin LiquiColor® and Total Bilirubin LiquiColor® test systems are devices intended to measure the levels of bilirubin (direct and total) in serum and plasma. Measurements of the levels of bilirubin, and organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.
The Direct Bilirubin LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2. The Total Bilirubin LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2.
Here's a breakdown of the acceptance criteria and study information for the Stanbio Direct Bilirubin LiquiColor® and Total Bilirubin LiquiColor® devices, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Direct Bilirubin) | Reported Device Performance (Total Bilirubin) |
|---|---|---|
| Precision (Intra-assay) | CV ≤ 3.12% (n=20) | CV ≤ 3.05% (n=20) |
| Precision (Inter-assay) | CV ≤ 3.34% (n=20) | CV ≤ 3.49% (n=20) |
| Correlation (vs. predicate) | r = 0.995 (y = 0.9394x - 0.06 mg/dL) | r = 0.999 (y = 1.0108x - 0.0145 mg/dL) |
| Sensitivity | 0.1 mg/dL per 0.001 absorbance units | 0.07 mg/dL per 0.001 absorbance units |
| Linearity | 0.1 to 10 mg/dL | 0.07 to 30 mg/dL |
| Comparison (Plasma vs. Serum) | r = 0.9999 (y = 1.0118x - 0.0078) | r = 0.9995 (y = 1.02x - 0.006) |
Note: The document does not explicitly state numerical acceptance thresholds for each criterion but presents the results of the performance studies. It is implied that these reported performance metrics were considered acceptable for demonstrating substantial equivalence. For instance, the high correlation coefficients (r) suggest strong agreement with the predicate devices, which is a common acceptance criterion for equivalence in such tests.
Study Details
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Sample size used for the test set and the data provenance:
- Direct Bilirubin Test Set:
- Correlation: 85 samples.
- Comparison (Plasma vs. Serum): 22 samples.
- Precision (Intra-assay & Inter-assay): n=20 for each sample level tested.
- Total Bilirubin Test Set:
- Correlation: 247 samples.
- Comparison (Plasma vs. Serum): 19 samples.
- Precision (Intra-assay & Inter-assay): n=20 for each sample level tested.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that these are in vitro diagnostic devices for measuring analytes in human samples, the samples would typically be human serum or plasma.
- Direct Bilirubin Test Set:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are quantitative assays for chemical analytes, not image-based or clinical diagnostic tests requiring expert interpretation to establish ground truth in the traditional sense. The "ground truth" for the correlation and comparison studies is established by the results from a "commercially available test" (Roche Direct Bilirubin/Total Bilirubin tests).
-
Adjudication method for the test set: Not applicable. No human interpretation or adjudication process is involved in determining the "ground truth" for these types of quantitative assays.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device's performance data (precision, sensitivity, linearity) represents standalone performance, as it is a fully automated/instrument-based chemical assay. The "correlation" and "comparison" studies are essentially comparisons of the new device's standalone performance against another commercially available standalone device.
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The type of ground truth used:
- For Correlation studies, the ground truth was established by the measurements obtained from the predicate devices: Roche Direct Bilirubin (K910593) and Roche Total Bilirubin (K910591).
- For Precision, Sensitivity, and Linearity, the ground truth is effectively the expected chemical value of the calibrators and samples used in the study, and the assessment is of the device's ability to consistently and accurately measure those values.
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The sample size for the training set: Not applicable. This is a chemical assay, not an machine learning/AI model that requires training data.
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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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(65 days)
The Direct Bilirubin assay is used for the quantitation of direct bilirubin in human serum and plasma. Measurement of direct bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Direct Bilirubin is an in vitro diagnostic assay for the quantitative determination of direct bilirubin in human serum and plasma. Direct (conjugated) bilirubin couples with a diazonium salt in the presence of sulfamic acid to form the colored compound, azobilirubin. The increase in absorbance at 548 nm due to azobilirubin formation is proportional to the direct bilirubin concentration.
Here's an analysis of the provided information regarding the acceptance criteria and study for the Direct Bilirubin assay:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined "acceptance criteria" but rather describes the performance characteristics that demonstrate substantial equivalence to a predicate device. The performance is presented as correlation and precision which are compared to a predicate device.
| Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (AEROSET System) | Reported Device Performance (ARCHITECT c8000 System) |
|---|---|---|---|
| Correlation Coefficient (r) | High correlation with predicate device | 0.995 | 0.996 |
| Slope | Close to 1 (when comparing to predicate) | 1.08 | 1.08 |
| Y-intercept | Close to 0 (when comparing to predicate) | 0.21 mg/dL | 0.21 mg/dL |
| Total %CV (Precision) | Acceptable (e.g., similar to predicate or within clinical limits) | Level 1: 3.6-4.1% Level 2: 0.9-2.6% Level 3: 1.0-2.7% Level 4: 0.7-2.6% | Level 1: 3.0-3.6% Level 2: 0.9-1.2% Level 3: 1.3-1.5% Level 4: 0.8-1.1% |
| Assay Range | Not explicitly stated as acceptance criteria, but reported | 0.1 to 16.9 mg/dL | 0.1 to 16.9 mg/dL |
| Limit of Quantitation (Sensitivity) | Not explicitly stated as acceptance criteria, but reported | 0.04 mg/dL | 0.04 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Comparative performance studies were conducted," but does not specify the sample size for these studies. It also does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For an in vitro diagnostic assay like this, "ground truth" would typically be established by comparison to a reference method or a legally marketed predicate device, rather than a panel of human experts in the way it might be for image analysis. The document refers to the "Roche Direct Bilirubin assay on the Hitachi® 717 Analyzer" as the predicate device used for comparison.
4. Adjudication Method for the Test Set
This concept is not applicable to this type of in vitro diagnostic device study. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving human readers, for example, to resolve disagreements in image interpretation. Here, the comparison is between the new device and an existing automated assay.
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 multiple human readers evaluating cases and is not relevant for an automated in vitro diagnostic assay that determines a quantitative measurement like bilirubin levels. The study is a comparison of instrument performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this study describes the standalone performance of the Direct Bilirubin assay. It evaluates the device's ability to measure direct bilirubin quantitatively on its own, without direct human interpretation influencing the measurement result itself (though human operators would run the tests). The performance metrics (correlation, slope, y-intercept, precision) are all indicative of the device's inherent analytical capability.
7. The Type of Ground Truth Used
The ground truth for the comparative performance studies was established by comparison to a legally marketed predicate device: the Roche Direct Bilirubin assay on the Hitachi 717 Analyzer. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices.
8. The Sample Size for the Training Set
This information is not provided in the document. For in vitro diagnostic assays, the "training set" would typically refer to the data used during the development and calibration of the assay, which is distinct from the validation studies presented for regulatory submission.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. Similar to point 8, the ground truth for an assay's development and calibration would typically involve a combination of reference materials, spiked samples, and comparison to established methods to ensure accuracy and precision across the measuring range.
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(63 days)
This device is intended for the quantitative determination of direct bilirubin in serum or plasma. Bilirubin is an organic compound formed during the catabolism of red blood cells and its measurement is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a "Direct Bilirubin Reagent." This document is an approval letter for a medical device and does not contain information about acceptance criteria, study details, or performance metrics.
Therefore, I cannot extract the requested information from the provided input. The document confirms that the device is "substantially equivalent" to legally marketed devices, but does not present the specific data from a study to demonstrate this.
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(60 days)
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(21 days)
The Direct Bilirubin assay is used for the quantitation of direct bilirubin in human serum or plasma. Measurements of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Direct Bilirubin is an in vitro diagnostic assay for the quantitative determination of direct bilirubin in human serum or plasma. The Direct Bilirubin assay is a clinical chemistry assay in which the conjugated bilirubin reacts with diazotised sulphanilic acid to produce an acid azobilirubin, the absorbance of which is proportional to the concentration of direct bilirubin in the sample and can be measured at 550 nm.
The Abbott Laboratories Direct Bilirubin assay is an in vitro diagnostic assay intended for the quantitative determination of direct bilirubin in human serum or plasma. The device functions by reacting conjugated bilirubin with diazotized sulfanilic acid to produce an acid azobilirubin, the absorbance of which is proportional to the concentration of direct bilirubin in the sample and can be measured at 550 nm.
The study that proves the device meets the acceptance criteria is a comparative performance study against the predicate device, the Roche® Cobas Mira® Plus Automated Chemistry System Direct Bilirubin assay (K910593).
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation to Predicate Device | |
| Correlation Coefficient | 0.9969 |
| Slope | 1.199 |
| Y-intercept | 0.369 mg/dL |
| Precision | |
| Total %CV (Level 1/Panel 111) | 6.7% |
| Total %CV (Level 2/Panel 112) | 2.8% |
| Linearity (Assay Range) | Up to 16 mg/dL |
| Limit of Quantitation (Sensitivity) | 0.3 mg/dL |
Note: The document states "Both assays yield similar Performance Characteristics" and "The Direct Bilirubin assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Direct Bilirubin assay." The specific numerical acceptance criteria for correlation coefficient, slope, and y-intercept are not explicitly stated, but the reported values of 0.9969, 1.199, and 0.369 mg/dL respectively, are presented as acceptable for demonstrating substantial equivalence.
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size used for the comparative performance studies (method comparison and precision studies).
- The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned in the provided text.
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 as the study design is a comparison to a predicate device, not a human expert-based ground truth establishment. The ground truth for this type of IVD is typically the analytical result from the predicate device or a reference method.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for this type of analytical performance study. The comparison is objective, based on quantitative measurements.
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 is not an MRMC comparative effectiveness study involving human readers or AI assistance. It is an analytical performance study of an in vitro diagnostic assay.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is a standalone diagnostic assay; its performance is evaluated based on its ability to quantitatively determine direct bilirubin, not in conjunction with human interpretation in the context of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the comparative study was the results obtained from the predicate device, the Roche® Cobas Mira® Plus Automated Chemistry System Direct Bilirubin assay.
8. The sample size for the training set:
- This is an analytical performance study of a diagnostic assay, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of diagnostic assay.
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(243 days)
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