(58 days)
The Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma. Measurement of total 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.
A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
Total Bilirubin is an in vitro diagnostic assay for the quantitative determination of total bilirubin in human serum or plasma of adults and neonates. Total (conjugated and unconjugated) bilirubin couples with the diazo reagent in the presence of a surfactant to form azobilirubin. The increase in absorbance at 548 nm due to azobilirubin formation is directly proportional to the total bilirubin concentration.
The provided document is a 510(k) summary for the Abbott Laboratories Total Bilirubin assay. It describes the device, its intended use, and performance characteristics compared to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a table format. Instead, it describes performance characteristics and considers them "substantially equivalent" if they show strong correlation and acceptable precision compared to a legally marketed predicate device. The implied acceptance criteria are high correlation coefficients (close to 1), acceptable slopes (close to 1), and small Y-intercepts (close to 0) when compared to the predicate.
| Performance Metric | Implied Acceptance Criteria (relative to predicate) | Reported Device Performance (AEROSET vs. Hitachi 717) | Reported Device Performance (ARCHITECT c8000 vs. Hitachi 717) | Reported Device Performance (ARCHITECT c8000 vs. AEROSET) |
|---|---|---|---|---|
| Adult Application (Correlation) | ||||
| Correlation Coefficient (r) | Close to 1.0 | 0.9992 | 0.9992 | 0.9999 |
| Slope | Close to 1.0 | 0.96 | 0.95 | 0.99 |
| Y-intercept (mg/dL) | Close to 0.0 | 0.22 | 0.20 | -0.02 |
| Neonate Application (Correlation) | ||||
| Correlation Coefficient (r) | Close to 1.0 | 0.9934 | 0.9921 | 0.9964 |
| Slope | Close to 1.0 | 0.96 | 0.98 | 1.02 |
| Y-intercept (mg/dL) | Close to 0.0 | 0.22 | 0.06 | -0.13 |
| Precision (Total %CV) | (Generally low, device-specific) | AEROSET: L1=1.33%, L2=1.56%, L3=1.32%, L4=0.9% | ARCHITECT c8000: L1=1.68%, L2=2.13%, L3=1.84%, L4=1.3% | Not applicable (intra-device precision) |
| Linearity | Defined range | 0.1 to 25 mg/dL | Not specified for predicate, implied match | Not specified for predicate, implied match |
| Functional Sensitivity (Limit of Quantitation) | Low |
§ 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.