(162 days)
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
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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.
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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.
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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.
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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 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.
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.