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510(k) Data Aggregation
(71 days)
ATAC PAK BUN REAGENT
The ATAC PAK BUN Reagent Kit is intended for the quantitative determination of urea nitrogen in serum, plasma and urine. Urea nitrogen results are used in the diagnosis and treatment of certain renal and metabolic diseases.
The ATAC PAK BUN Reagent determines urea nitrogen through the enzymatic action of urease and glutamate delydrogenase. The resulting decrease in absorbance at 340 nm is proportional to the urea nitrogen concentration of the sample.
This document focuses on the ATAC PAK BUN Reagent Kit, an in-vitro diagnostic device designed for the quantitative determination of urea nitrogen. The provided text describes the device's performance characteristics and how they demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|
| Linearity/Recovery | Linear from 2 to 100 mg/dL | (ATAC Recoveries) = 0.6 mg/dL + 0.9775 x (Standard Value), sy.x = 1.2 mg/dL. The recovery of urea nitrogen is linear from 2 to 100 mg/dL. |
| Precision (Within Run) | Not explicitly stated but implied to be low CV% to demonstrate reliability | Serum 1: n=60, mean=7 mg/dL, 1SD=0.3, %CV=4.4% |
| Serum 2: n=60, mean=34 mg/dL, 1SD=0.5, %CV=1.5% | ||
| Serum 3: n=60, mean=61 mg/dL, 1SD=0.9, %CV=1.4% | ||
| Urine 1: n=60, mean=21 mg/dL, 1SD=0.4, %CV=2.1% | ||
| Urine 2: n=60, mean=80 mg/dL, 1SD=1.0, %CV=1.3% | ||
| Precision (Total) | Not explicitly stated but implied to be low CV% to demonstrate reliability | Serum 1: 1SD=0.4, %CV=5.6% |
| Serum 2: 1SD=0.8, %CV=2.3% | ||
| Serum 3: 1SD=1.1, %CV=1.9% | ||
| Urine 1: 1SD=0.5, %CV=2.5% | ||
| Urine 2: 1SD=1.4, %CV=1.7% | ||
| Method Comparison (Serum/Plasma) | Strong correlation (high r-value) and close agreement with competitive method | ATAC 8000 = 1.2 mg/dL + 0.977 x Competitive Reagent, r = 0.996 |
| Method Comparison (Urine) | Strong correlation (high r-value) and close agreement with competitive method | ATAC 8000 = 1.9 mg/dL + 0.9525 x Competitive Reagent, r = 0.991 |
| Detection Limit | 2 mg/dL | 2 mg/dL (documented by repetitive assay of diluted serum control, 30 replicates, 0 mg/dL std dev) |
| On-board Reagent Stability | 14 days; total imprecision |
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(61 days)
ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS
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