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510(k) Data Aggregation
(64 days)
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 < 5% for clinical assays | Serum 1: 2.5% CV (at 2.5 g/dL) Serum 2: 2.3% CV (at 3.9 g/dL) Serum 3: 1.6% CV (at 5.3 g/dL) | Precision |
| Total Precision | %CV typically < 5% or 10% for clinical assays | Serum 1: 3.3% CV (at 2.5 g/dL) Serum 2: 2.8% CV (at 3.9 g/dL) Serum 3: 2.3% CV (at 5.3 g/dL) | Precision |
| Method Comparison (Correlation) | High correlation and low bias when compared to predicate | ATAC 8000 = 0.5 + 0.867 x Competitive Reagent, Sy.x = 0.11 g/dL | Method Comparison |
| Method Comparison (Range) | Cover clinically relevant range | 1.9 - 5.4 g/dL | Method Comparison |
| Detection Limit | Below the lowest clinically relevant value | 0.1 g/dL | Detection Limit |
| Reagent Stability (Onboard) | Maintain performance over claim | Total imprecision < 0.15 g/dL or 3% over 14 days | Stability |
| Calibration Stability | Maintain performance over claim | Total imprecision < 0.15 g/dL or 3% over 7 days | Stability |
2. Sample Size and Data Provenance
- Linearity/Recovery: n = 33 (implied by the regression statistics, corresponding to pairs of ATAC recoveries vs. Reference Values). The data provenance is not explicitly stated but implies laboratory-prepared linearity standards.
- Precision:
- Serum 1: n = 60 replicates
- Serum 2: n = 60 replicates
- Serum 3: n = 60 replicates
- The samples used are "commercially available control serum." The country of origin is not specified, and the study is prospective in nature for determining precision.
- Method Comparison: n = 119 for mixed serum and plasma specimens. These were "collected from adult patients," suggesting a prospective collection of clinical samples. The country of origin is not specified.
- Detection Limit: n = 30 replicates of a diluted serum pool. This is a prospective study.
- Stability Studies: "serum controls" were assayed. Specific sample sizes for controls are not given, but the study is prospective.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. This device is a diagnostic reagent kit, and the "ground truth" for its performance is established through analytical validation studies using reference methods, standards, and control materials, rather than expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method
- Not applicable. As described above, the studies involve analytical measurements against established reference values or comparative measurements with a predicate device, not subjective interpretation requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case comparative effectiveness study was not done. This type of study is typically performed for medical imaging devices where human interpretation is a critical component of the diagnostic process. This submission pertains to an in-vitro diagnostic reagent kit for quantitative biochemical measurement.
6. Standalone Performance Study
- Yes, a standalone (algorithm only) performance study was done for the ATAC PAK Albumin Reagent Kit. The studies presented (linearity, precision, method comparison, detection limit, stability) directly assess the performance of the reagent kit when run on the ATAC 8000 Random Access Chemistry System, without human interpretive input affecting the core measurement.
7. Type of Ground Truth Used
The ground truth for the performance studies was established through:
- Reference Values: For linearity, values are compared against "Reference Value" standards.
- Commercial Control Serum: For precision, commercially available control sera with assigned values (mean, 1SD, %CV) serve as the reference.
- Predicate Device/Commercially Available Method: For method comparison, the results from the ATAC PAK Albumin Reagent Kit are compared against results from an "another commercially available method" (the predicate device).
- Established Analytical Principles: For detection limit, it's based on the statistical calculation from repetitive assays of a diluted serum pool.
8. Sample Size for the Training Set
- Not applicable. This device is an in-vitro diagnostic reagent kit, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and photometric measurements. The manufacturing process and quality control would be validated, but there isn't a "training set" for the reagent itself.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this device.
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