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510(k) Data Aggregation
(60 days)
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
ELITech Clinical Systems BILIRUBIN TOTAL 4+1 is intended for the quantitative in vitro diagnostic determination of total bilirubin in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is intended for the quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers.
It is not intended for use in Point of Care settings.
Measurements of the levels of bilirubin (direct or total), an organic compound formed during the normal and abnormal distruction of red blood cells, are used in the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.
ELITech Clinical Systems BILIRUBIN TOTAL 4+1 and ELITech Clinical Systems BILIRUBIN DIRECT 4+1 are available as a kit only. Each kit consists of a bi-reagent R1 & R2.
ELITech Clinical Systems BILIRUBIN TOTAL 4+1:
Reagent 1: R1 Sulphanilic acid 29 mmol/L, Cetrimide 29 mmol/L.
Reagent 2: R2 Sodium nitrite 11 mmol/L.
ELITech Clinical Systems BILIRUBIN DIRECT 4+1:
Reagent 1: R1 Sulphanilic acid 29 mmol/L,
Reagent 2: R2 Sodium nitrite 11 mmol/L.
The document describes the analytical performance and comparison studies for the ELITech Clinical Systems BILIRUBIN TOTAL 4+1 and ELITech Clinical Systems BILIRUBIN DIRECT 4+1 devices. These devices are intended for the quantitative in vitro diagnostic determination of total and direct bilirubin, respectively, in human serum and plasma. The studies aim to demonstrate substantial equivalence to predicate devices (ABX Pentra Bilirubin, Total CP & ABX Pentra Bilirubin, Direct CP).
Here's the breakdown of the information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
For ELITech Clinical Systems BILIRUBIN TOTAL 4+1:
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Precision | Within-run CV% | Not explicitly stated as a numerical criterion, but evaluated by comparing with predicate device and clinical requirements for bilirubin assays. | Level 1 (1.15 mg/dL): 1.8% |
| Level 2 (4.08 mg/dL): 0.4% | |||
| Level 3 (14.61 mg/dL): 0.5% | |||
| Total CV% | Not explicitly stated as a numerical criterion. | Level 1 (1.15 mg/dL): 5.0% | |
| Level 2 (4.08 mg/dL): 3.1% | |||
| Level 3 (14.61 mg/dL): 2.9% | |||
| Linearity/Reportable Range | Measuring Range | Not explicitly stated as a numerical criterion, but evaluated to cover clinically relevant range. | 0.25 - 25 mg/dL (up to 60.00 mg/dL with auto-dilution) |
| Detection Limit | Limit of Detection (LoD) | Not explicitly stated as a numerical criterion. | 0.04 mg/dL (0.7 µmol/L) |
| Quantification Limit | Limit of Quantification (LoQ) | ≤ 0.07 mg/dL Total Error, and ≥ LoD. | 0.15 mg/dL (2.6 µmol/L) |
| Interference | Bias | Acceptance criterion: ±10% bias for nominal activities of 1.00 mg/dL and 15.00 mg/dL. | Triglycerides: No significant interference up to 2100 mg/dL |
| Hemoglobin: No significant interference up to 500 mg/dL | |||
| Acetaminophen: No significant interference up to 30 mg/dL | |||
| Ascorbic acid: No significant interference up to 4 mg/dL | |||
| Acetylsalicylic acid: No significant interference up to 200 mg/dL | |||
| Method Comparison | Correlation (r) | Not explicitly stated as a numerical criterion, but assessed for strong correlation with predicate. | r = 0.999 |
| Coefficient of Determination (r²) | Not explicitly stated as a numerical criterion. | r² = 0.999 | |
| Standard error of the estimate (Sy.x) | Not explicitly stated as a numerical criterion. | 0.19 mg/dL | |
| Matrix Comparison | Correlation (r) | Not explicitly stated as a numerical criterion. | r = 0.998 |
| Coefficient of Determination (r²) | Not explicitly stated as a numerical criterion. | r² = 0.997 | |
| Standard error of the estimate (Sy.x) | Not explicitly stated as a numerical criterion. | 0.36 mg/dL |
For ELITech Clinical Systems BILIRUBIN DIRECT 4+1:
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Precision | Within-run CV% | Not explicitly stated as a numerical criterion. | Level 1 (0.36 mg/dL): 3.8% |
| Level 2 (1.51 mg/dL): 1.9% | |||
| Level 3 (3.99 mg/dL): 0.9% | |||
| Total CV% | Not explicitly stated as a numerical criterion. | Level 1 (0.36 mg/dL): 5.2% | |
| Level 2 (1.51 mg/dL): 5.3% | |||
| Level 3 (3.99 mg/dL): 4.7% | |||
| Linearity/Reportable Range | Measuring Range | Not explicitly stated as a numerical criterion. | 0.08 - 10.55 mg/dL (up to 50.00 mg/dL with auto-dilution) |
| Detection Limit | Limit of Detection (LoD) | Not explicitly stated as a numerical criterion. | 0.01 mg/dL (0.2 µmol/L) |
| Quantification Limit | Limit of Quantification (LoQ) | ≤ 0.05 mg/dL Total Error, and ≥ LoD. | 0.08 mg/dL (1.4 µmol/L) |
| Interference | Bias | Acceptance criterion: ±10% bias for nominal activities of 0.40 mg/dL and 4.00 mg/dL. | Triglycerides: No significant interference up to 2000 mg/dL |
| Hemoglobin: No significant interference up to 125 mg/dL | |||
| Acetaminophen: No significant interference up to 30 mg/dL | |||
| Ascorbic acid: No significant interference up to 0.5 mg/dL | |||
| Acetylsalicylic acid: No significant interference up to 200 mg/dL | |||
| Method Comparison | Correlation (r) | Not explicitly stated as a numerical criterion. | r = 0.998 |
| Coefficient of Determination (r²) | Not explicitly stated as a numerical criterion. | r² = 0.995 | |
| Standard error of the estimate (Sy.x) | Not explicitly stated as a numerical criterion. | 0.15 mg/dL | |
| Matrix Comparison | Correlation (r) | Not explicitly stated as a numerical criterion. | r = 0.999 |
| Coefficient of Determination (r²) | Not explicitly stated as a numerical criterion. | r² = 0.997 | |
| Standard error of the estimate (Sy.x) | Not explicitly stated as a numerical criterion. | 0.14 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
-
Precision (Test Set):
- Sample Size: 80 measurements for each of 3 levels of samples (total 240 measurements per device) per instrument (2 instruments used).
- Data Provenance: Not explicitly stated (e.g., country of origin). The samples are referred to as "samples" or "patient samples." The study was prospective in the sense that controlled experiments were performed to gather data for precision.
-
Linearity (Test Set):
- ELITech Clinical Systems BILIRUBIN TOTAL 4+1: 11 levels of mixed samples.
- ELITech Clinical Systems BILIRUBIN DIRECT 4+1: 11 levels of mixed samples.
- Data Provenance: Not explicitly stated. Likely prepared in a laboratory setting.
-
Detection Limit (Test Set):
- Sample Size: 15 measurements of 4 samples for each device.
- Data Provenance: Prepared from patient samples and diluted with Albumin 6 g/dL - NaCl 0.9 %.
-
Interference (Test Set):
- Sample Size: For each potential interferent, 2 serum sample pools (low and high concentration), with aliquots spiked at various interferent concentrations (9 or 7 or 8 different concentrations). Each point was measured in triplicate per run. Two levels of control were also tested. A control sample was prepared from the sample pool diluted in appropriate diluent.
- Data Provenance: "Serum sample pools." Not explicitly stated.
-
Method Comparison (Test Set):
- Sample Size: 100 serum patient samples for each device.
- Data Provenance: "Serum patient samples." Not explicitly stated, but likely from a clinical laboratory or hospital in the country where the studies were conducted (France or USA, as these are locations given for the submitter and contact person). The study was likely prospective in nature for collecting these samples for comparison against the predicate.
-
Matrix Comparison (Test Set):
- Sample Size: 40 plasma patients (lithium heparin samples) for each device.
- Data Provenance: "Plasma patients." Not explicitly stated. Likely from a clinical laboratory or hospital.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For this type of in vitro diagnostic device (quantitative measurement of bilirubin), the "ground truth" is typically established by reference methods or comparison to legally marketed predicate devices, not by expert interpretation. The predicate devices are considered the "ground truth" for the method comparison studies. The document implicitly uses the performance of the legally marketed predicate device (ABX Pentra Bilirubin, Total CP & ABX Pentra Bilirubin, Direct CP) as the standard against which the new device's performance is compared for substantial equivalence.
There is no mention of experts establishing ground truth in the traditional sense of medical imaging or clinical diagnosis.
4. Adjudication Method for the Test Set
Not applicable. This is an in vitro diagnostic device performing quantitative measurements, not an AI or imaging device requiring human adjudication of results. The performance is assessed by comparing quantitative results against reference or predicate methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically for imaging devices where human readers interpret medical images with and without AI assistance. The described device is an in vitro diagnostic assay.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone performance evaluations of the device (reagents on an analyzer). The device itself (the reagent system) functions as an "algorithm only" in the sense that it performs the chemical reaction and measurement without human interpretive input for each test result. Clinical laboratory technologists would operate the analyzer and interpret the numerical results, but the analytical performance described is the device's intrinsic capability.
7. The Type of Ground Truth Used
The primary ground truth for demonstrating substantial equivalence is the performance of the legally marketed predicate devices (ABX Pentra Bilirubin, Total CP & ABX Pentra Bilirubin, Direct CP). In the method comparison studies, the results from the new devices are compared against the results from the predicate devices using patient samples.
Additionally, for analytical performance like linearity, detection limit, and interference, the "ground truth" for evaluating the performance of the device is based on prepared samples with known concentrations or expected behaviors (e.g., spiked samples with interferents, serially diluted samples).
8. The Sample Size for the Training Set
Not applicable. This device is an in vitro diagnostic reagent system, not an AI/ML-based device that requires a "training set" in the computational sense. Its performance is based on chemical reactions and instrumental measurements, which are validated through analytical studies.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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