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510(k) Data Aggregation
(64 days)
ATAC PAK ALBUMIN REAGENT
The ATAC PAK Albumin Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of albumin in serum and plasma. Albumin results are used for the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
The ATAC PAK Albumin Reagent Kit is intended for the quantitative determination of albumin in serum and plasma. Albumin results are used for the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. The ATAC PAK Albumin Reagent determines albumin by the selective binding of bromcresol green. The resulting increase in absorbance at 630 nm is proportional to the albumin concentration in the sample.
The ATAC PAK Albumin Reagent Kit is intended for the quantitative determination of albumin in serum and plasma. The study presented demonstrates its substantial equivalence to the Roche Albumin Reagent Kit (product no. 1970569).
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied by equivalence to predicate) | Reported Device Performance | Study Type |
|---|---|---|---|
| Linearity Range | Equivalent to predicate (e.g., span useable range) | 0.1 to 8 g/dL | Linearity/Recovery |
| Recovery Regression | High correlation (e.g., r > 0.99) and low Sy.x | ATAC = 0.04 + 0.902x (Ref), r = 0.999, Sy.x = 0.11 g/dL | Linearity/Recovery |
| Within-Run Precision | %CV typically |
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