(200 days)
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 analyzers. It is not intended for use in Point of Care settings. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.
ELITech Clinical Systems BILIRUBIN DIRECT 4+1 is intended the quantitative in vitro diagnostic determination of direct bilirubin in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder blockage.
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in the quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems BILIRUBIN TOTAL 4+1: The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains sulfanilic acid, Hydrochloric acid and cetrimide. Reagent R2 contains sodium nitrite.
ELITech Clinical Systems BILIRUBIN DIRECT 4+1: The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains sulfanilic acid and Hydrochloric acid. Reagent R2 contains sodium nitrite.
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the ELITech Clinical Systems Bilirubin devices.
Important Note: The provided text is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive, independent study seeking to establish the device's absolute performance against a
predefined, absolute acceptance criteria. The "acceptance criteria" in this context refer to the performance benchmarks the new device needs to meet to be considered "substantially equivalent" to an already cleared device, typically by showing similar or better performance in key metrics. The study described is a comparison study against the predicate, not a study to prove meeting absolute acceptance criteria in the same way a de novo or PMA device would.
Acceptance Criteria and Device Performance for ELITech Clinical Systems BILIRUBIN TOTAL 4+1
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | ELITech Clinical Systems BILIRUBIN TOTAL 4+1 (New Device) Performance | Predicate Device (ABX PENTRA BILIRUBIN, TOTAL CP) Performance | Substantial Equivalence Criteria (Implied) |
|---|---|---|---|
| Measuring Range | 0.28 to 20.22 mg/dL | 0.2 to 26.3 mg/dL | Comparable measuring range (within clinically acceptable limits) |
| Limit of Detection | 0.06 mg/dL | 0.09 mg/dL | Comparable or better LoD |
| Limit of Quant. | 0.17 mg/dL | 0.14 mg/dL | Comparable or better LoQ |
| Precision (Within Run) | Level 1.04 mg/dL: CV=2.7% | Level 0.97 mg/dL: CV=2.14% | Comparable or better precision |
| Level 3.67 mg/dL: CV=0.8% | Level 5.13 mg/dL: CV=0.99% | ||
| Level 14.90 mg/dL: CV=0.5% | Level 0.61 mg/dL: CV=3.09% | ||
| Level 0.85 mg/dL: CV=2.23% | |||
| Level 2.20 mg/dL: CV=1.33% | |||
| Precision (Total) | Level 1.04 mg/dL: CV=4.0% | Level 1.0 mg/dL: CV=4.04% | Comparable or better precision |
| Level 3.67 mg/dL: CV=2.0% | Level 5.5 mg/dL: CV=1.70% | ||
| Level 14.90 mg/dL: CV=1.8% | Level 0.8 mg/dL: CV=5.97% | ||
| Level 2.9 mg/dL: CV=2.78% | |||
| Level 9.1 mg/dL: CV=2.20% | |||
| Method Comparison (Correlation) | y=0.924x + 0.02 mg/dL, r² = 0.998 | y=1.03x - 0.14 mg/dL, r² = 0.9965 | High correlation (r² close to 1) indicating agreement with predicate. Equation slope and intercept should demonstrate clinical equivalence. |
| (Range) | 0.25 to 22.00 mg/dL | 0.3 to 25.8 mg/dL | Consistent measurement range for method comparison. |
| Limitations (Interference) | Triglycerides: No significant interference up to 2779 mg/dL | Triglycerides: No significant influence up to 612.5 mg/dL | Comparable or better interference profile, especially for common interferents. |
| Hemoglobin: No significant interference up to 500 mg/dL | Hemoglobin: No significant influence up to 500 mg/dL | ||
| Acetaminophen: No significant interference up to 30 mg/dL | (Not reported for predicate in summary) | ||
| Ascorbic acid: Interference > 2.0 mg/dL | (Not reported for predicate in summary) | ||
| Acetylsalicylic acid: No significant interference up to 200 mg/dL | (Not reported for predicate in summary) | ||
| Calibration Freq. | 28 days | 10 days | Device performance maintained over specified calibration period. (Better is generally preferred) |
| On-board Stability | 28 days (refrigerated area) | 25 days (refrigerated area) | Device performance maintained over specified on-board stability. (Better is generally preferred) |
Study Details for ELITech Clinical Systems BILIRUBIN TOTAL 4+1
The information provided is a 510(k) Summary, which typically presents a comparison between a new device and a legally marketed predicate device to establish "substantial equivalence." It doesn't detail a standalone study with pre-defined, absolute acceptance criteria in the same way a full clinical trial would. Instead, the "study" is a series of in-vitro analytical performance tests comparing the new device against the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the total number of patient samples used for the method comparison or interference studies. For precision, specific levels are tested, but the number of replicates/runs is not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's an in-vitro diagnostic, the samples would likely be human serum and plasma, possibly from a clinical lab setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This is an in-vitro diagnostic device for quantitative measurement. The "ground truth" for the test set is established by the measurements obtained from the predicate device (ABX PENTRA BILIRUBIN, TOTAL CP) and potentially reference methods or characterized materials for analytical performance studies (e.g., linearity, LoD, LoQ).
- No human experts (e.g., radiologists, pathologists) are explicitly mentioned as establishing ground truth in this context, as the output is a quantitative biochemical measurement, not an interpretive one.
4. Adjudication Method for the Test Set
- Not applicable as this is an analytical performance study comparing quantitative measurements, not an interpretive study requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC study was not done. This type of study is relevant for interpretive tasks where human readers (e.g., radiologists) provide diagnoses, and AI assistance is evaluated. This device is an automated in-vitro diagnostic assay.
6. Standalone Performance (Algorithm only without human-in-the-loop performance)
- Yes, the performance metrics reported (Measuring range, LoD, LoQ, Precision, Method Comparison, Limitations) are for the standalone algorithm/device as an automated assay. There is no human intervention in the measurement process other than preparing samples and operating the analyzer.
7. Type of Ground Truth Used
- The "ground truth" for comparative purposes against the predicate device is implied to be the measurements obtained from the predicate device itself for method comparison studies. For other analytical performance elements (LoD, LoQ, precision), validated reference materials or spiked samples are typically used.
8. Sample Size for the Training Set
- The document does not specify a "training set" size. This is an analytical device where performance is characterized rather than a machine learning algorithm that is "trained" on a dataset in the conventional sense. The device's components (reagents, analyzer settings) are developed and optimized, but the concept of a "training set" as used in AI/ML is not directly applicable here.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there's no conventional "training set" for a machine learning algorithm. The development and optimization of the reagent formulation and instrument parameters would be based on established chemical and analytical principles and potentially internal validation studies with characterized samples.
§ 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.