(64 days)
COBAS INTEGRA Bilirubin Direct Gen.2 is an in vitro test for the quantitative determination of direct bilirubin in human serum and plasma on COBAS INTEGRA systems. Measurement of the levels 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.
COBAS INTEGRA Bilirubin Direct Gen.2 reagent provides quantitative measurement of the direct bilirubin that is present in a human serum or human plasma sample. Reagents are packaged in a cassette with two bottles labeled with their instrument positioning, R1 and SR. R1, or Reagent 1, contains Phosphoric acid 85 mmol/L, NaCl 50 mmol/L, and HEDTA 4.0 mmol/L at pH 1.9. SR, or Start Reagent, is a 3,5-dichlorophenyl diazonium salt at 1.5 mmol/L in acid buffer, pH 1.3.
Here's a summary of the acceptance criteria and study information for the COBAS INTEGRA Bilirubin Direct Gen.2 reagent, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (COBAS INTEGRA Bilirubin Direct Gen.2) |
|---|---|---|
| Precision/Reproducibility | Based on CLSI EP5-A2 guidelines. | Repeatability: |
- Human Serum 1 (0.12 mg/dL): SD 0.01 mg/dL, CV 7.4%
- Human Serum 2 (3.8 mg/dL): SD 0.01 mg/dL, CV 0.4%
- Human Serum 3 (13.2 mg/dL): SD 0.04 mg/dL, CV 0.3%
Intermediate Precision: - Human Serum 1 (0.12 mg/dL): SD 0.01 mg/dL, CV 7.7%
- Human Serum 2 (3.8 mg/dL): SD 0.04 mg/dL, CV 1.0%
- Human Serum 3 (13.2 mg/dL): SD 0.05 mg/dL, CV 0.4% |
| Measuring Range (Linearity) | Based on CLSI EP6-A guidelines. | Plasma: Range tested 0.01 - 19.5 mg/dL, Range found 0.01 - 19.5 mg/dL, Recommended measuring range 0.07 - 13.8 mg/dL
Serum: Range tested 0.02 - 19.4 mg/dL, Range found 0.02 - 17.4 mg/dL, Recommended measuring range 0.07 - 13.8 mg/dL
Both showed a significant quadratic model, with linear regression for serum y = 1.0000x + 0.0000 (r² = 0.9944) and for plasma y = 1.0000x - 0.0000 (r² = 0.9977). |
| Detection Limits (LoB, LoD, LoQ) | Based on CLSI EP17-A2 guidelines. | LoB claim: 0.05 mg/dL
LoD claim: 0.07 mg/dL
LoQ claim: 0.07 mg/dL (based on 20% CV) |
| Analytical Specificity (Endogenous Substances) | "No significant interference" | Lipemia: No significant interference up to an L index of 750 (reported lowest L index for no interference was 1098).
Hemolysis: No significant interference up to an H index of 25 (reported lowest H index for no interference was 25). |
| Analytical Specificity (Common Drugs) | "No interference" from specific drugs. | Phenylbutazone causes falsely low bilirubin results (stated in labeling). The other 17 tested drugs (e.g., Acetylcystein (150 mg/L), Ampicillin - Na (1000 mg/L), Ascorbic acid (300 mg/L), Heparin - Na (5000 U)) produce no interference. |
| Method Comparison with Predicate Device | Substantial equivalence to predicate device (COBAS INTEGRA Bilirubin Direct). | Passing/Bablok regression with predicate device showed: y = 1.0490x + 0.0699 mg/dL with R² = 0.9979. |
| Matrix Comparison (Anticoagulants) | Median recovery: 90 to 110%
Median absolute deviation:
§ 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.