(67 days)
TBIL Flex® reagent cartridge: The TBIL method is an in vitro diagnostic test for the quantitative measurement of total bilirubin in human serum and plasma on the Dimension Vista™ System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder disease.
TDBIL Calibrator: The TDBIL CAL is an in vitro diagnostic product for calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista™ System.
TBIL Flex® reagent cartridge: Diazotized sulfanilic acid is formed by combining sodium nitrite and sulfanilic acid at low pH. Bilirubin (unconjugated) in the sample is solubilized by dilution in a mixture of caffeine/benzoate/acetate/EDTA. Upon addition of the diazotized sulfanilic acid, the solubilized bilirubin including conjugated bilirubins (mono and diglucoronides) and the delta form (biliprotein-bilirubin covalently bound to albumin) is converted to diazo-bilirubin, a red chromophore representing the total bilirubin which absorbs at 540 nm and is measured using a bichromatic (540, 700 nm) endpoint technique. A sample blank correction is used.
Total bilirubin and Direct bilirubin calibrator: The TDBIL calibrator is a two level calibrator. Level 1, purified water, is provided through the on-board Dimension Vista™ system. Level 2 is a lyophilized human serum based material spiked with ditaurobilirubin and traceable to NIST Standard Reference Material 916a.
Here's a breakdown of the acceptance criteria and the study information for the Dade Behring Dimension Vista™ TBIL Flex® reagent cartridge and TDBIL Calibrator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Dimension Vista™ TBIL Assay) |
|---|---|---|
| TBIL Flex® reagent cartridge | ||
| Intended Use | Quantitative determination of total bilirubin in serum and plasma. | Quantitative measurement of total bilirubin in human serum and plasma on the Dimension Vista™ System. Used in diagnosis and treatment of liver, hemolytic hematological and metabolic disorders (hepatitis, gall bladder disease). |
| Sample type | Human serum and plasma | Human serum and plasma |
| Methodology | Photometric (diazo chemistry) | Photometric (diazo chemistry) |
| Detection | Bichromatic (540, 700 nm) | Bichromatic (540, 700 nm) |
| Sample volume | 28 uL | 5 uL |
| Hemoglobin Correction | Up to 500 mg/dL Hemoglobin | Up to 1000 mg/dL Hemoglobin |
| Analytical Sensitivity | Not provided | 0.1 mg/dL |
| Within Lab Precision | 2.4%CV at 0.9 mg/dL; 9.6%CV @ 18.9 mg/dL | 5%CV @ 0.9 mg/dL; 2.9%CV @ 19.3 mg/dL |
| Reference Interval |
§ 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.