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510(k) Data Aggregation
(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 |
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