(8 days)
The Vitalab Direct Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of conjugated (direct) bilirubin in serum and plasma. Direct bilirubin results may be used for the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.
The Vitalab Total Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results may be used for the diagnosis and treatment af liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
The Vitalab Bilirubin Calibrator is intended to calibrate the Vitalab Selectra Analyzer for the quantitative determination of total and direct bilirubin in serum and plasma.
The Vitalab Direct Bilirubin Reagent is a two-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines conjugated bilirubin through a reaction with diazotized 2,4-dichloroanaline to produce a colored chromogen in acidic solution.
The Vitalab Total Bilirubin Reagent is a two-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines total bilirubin through a reaction with diazotized 2,4-dichloroanaline in the presence of detergents to produce a colored chromogen in acidic solution.
The Vitalab Bilirubin Calibrator is a liquid stable bilirubin calibrator prepared from purified components in a human serum albumin matrix. Bilirubin set points are traceable to NIST reference materials.
Below is a summary of the acceptance criteria and performance study details for the Vitalab Direct Bilirubin Reagent, Vitalab Total Bilirubin Reagent, and Vitalab Bilirubin Calibrator, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Vitalab Direct Bilirubin Reagent Acceptance Criteria / Predicate Performance (Implicit) | Vitalab Direct Bilirubin Reagent Reported Performance | Vitalab Total Bilirubin Reagent Acceptance Criteria / Predicate Performance (Implicit) | Vitalab Total Bilirubin Reagent Reported Performance |
|---|---|---|---|---|
| Linearity/Usable Range | Sufficiently linear to meet clinical needs (implicit, typically based on predicate). | Linear to at least 10.0 mg/dL. | Sufficiently linear to meet clinical needs (implicit, typically based on predicate). | Linear to at least 25.0 mg/dL. |
| Detection Limit | Low enough for clinical utility (implicit). | 0.0 mg/dL. | Low enough for clinical utility (implicit). | 0.0 mg/dL. |
| Precision | Acceptable within-run and total precision for clinical use (implicit, often referenced to NCCLS guidelines). | Serum 1 (0.3 mg/dL): Within Run 1SD = 0.03, %CV = 11.3%; Total 1SD = 0.03, %CV = 11.4%. | ||
| Serum 2 (1.7 mg/dL): Within Run 1SD = 0.02, %CV = 1.3%; Total 1SD = 0.05, %CV = 2.8%. | ||||
| Serum 3 (4.0 mg/dL): Within Run 1SD = 0.02, %CV = 0.5%; Total 1SD = 0.10, %CV = 2.6%. | Acceptable within-run and total precision for clinical use (implicit, often referenced to NCCLS guidelines). | Serum 1 (0.4 mg/dL): Within Run 1SD = 0.02, %CV = 5.8%; Total 1SD = 0.03, %CV = 6.7%. | ||
| Serum 2 (1.4 mg/dL): Within Run 1SD = 0.04, %CV = 3.1%; Total 1SD = 0.07, %CV = 4.8%. | ||||
| Serum 3 (5.8 mg/dL): Within Run 1SD = 0.07, %CV = 1.1%; Total 1SD = 0.15, %CV = 2.5%. | ||||
| Correlation/Method Comparison | Substantially equivalent to predicate device (implicit standard for 510(k)). | Selectra = 0.05 mg/dL + 0.832 x Competitive Reagent (r=0.9995, syx = 0.12 mg/dL if we assume the r and syx from linearity applies to correlation, which is probably incorrect, but no other value given for correlation specific r, syx). Range = 0.1 - 11.6 mg/dL. syx = 0.14 mg/dL (from calibration section, which seems to refer back to this data). | Substantially equivalent to predicate device (implicit standard for 510(k)). | Selectra = -0.4 mg/dL + 1.037 x Competitive Reagent. Range = 0.1 - 25.9 mg/dL. syx = 0.20 mg/dL. |
| Stability (Onboard Reagent & Calibration) | Meet claimed stability (implicit). | 14 day onboard reagent stability and 7 day calibration stability met (total imprecision |
§ 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.