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510(k) Data Aggregation
(105 days)
ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR
The ATAC PAK Uric Acid Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of uric acid in serum and plasma. Unc acid results are for the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gour, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
The ATAC PAK Uric Acid Reagent determines uric acid through the exzymatic oxidation coupled with a Trinder indicator reaction. The resulting increase in absorbance at 510 mm is proportional to the uric acid concentration of the sample.
The provided text describes the ATAC PAK Uric Acid Reagent Kit and its performance studies as part of a 510(k) submission. It's important to note that this is a diagnostic reagent, not an AI-based device, so some of the requested categories (like "effect size of how much human readers improve with AI vs without AI assistance" or "adjudication method") are not applicable in the context of this product. I will address the relevant information as presented in the document.
Acceptance Criteria and Reported Device Performance for ATAC PAK Uric Acid Reagent Kit
The studies were conducted to demonstrate the substantial equivalence of the ATAC PAK Uric Acid Reagent Kit to a legally marketed predicate device (Roche Uric Acid Reagent Kit) on the ATAC 8000 Random Access Chemistry System.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Linearity/Recovery | Linear recovery across the usable range (0.2 to 25 mg/dL) with strong correlation to standard values. | The recovery of uric acid is linear from 0.2 to 25 mg/dL. |
| Regression statistics: (ATAC Recoveries) = 0.996 x (Standard Value), r = 0.9998, sy.x = 0.18 mg/dL, n = 30. | ||
| Precision (Within Run) | Low coefficient of variation (CV) and standard deviation (1SD) for control samples. | Serum 1 (mean 2.3 mg/dL): 1SD = 0.12 mg/dL, %CV = 5.0% |
| Serum 2 (mean 6.9 mg/dL): 1SD = 0.16 mg/dL, %CV = 2.3% | ||
| Serum 3 (mean 11.3 mg/dL): 1SD = 0.19 mg/dL, %CV = 1.7% | ||
| Precision (Total) | Low coefficient of variation (CV) and standard deviation (1SD) for control samples across multiple runs/days. | Serum 1 (mean 2.3 mg/dL): 1SD = 0.23 mg/dL, %CV = 9.8% |
| Serum 2 (mean 6.9 mg/dL): 1SD = 0.30 mg/dL, %CV = 4.4% | ||
| Serum 3 (mean 11.3 mg/dL): 1SD = 0.38 mg/dL, %CV = 3.4% | ||
| Method Comparison | Strong correlation and agreement with a commercially available comparative method. | Regression statistics: ATAC 8000 = - 0.11 mg/dL + 0.987 x Competitive Reagent, syx = 0.29 mg/dL, n=120, range = 1.8 - 18.8 mg/dL. |
| Detection Limit | Low detection limit, accurately determined. | 0.2 mg/dL. Documented by repetitive assay of a diluted serum pool; observed standard deviation of a 30-replicate within-run precision study was 0.1 mg/dL. The detection limit is reported as twice the round-off error of the assay (implying 0.1 mg/dL * 2 = 0.2 mg/dL). |
| Reagent Stability | Observed change in control recoveries less than 0.3 mg/dL over 14 days. | The observed change in control recoveries was less than 0.3 mg/dL over the claimed 14-day on-board reagent stability period. |
| Calibration Stability | Total imprecision of uric acid recoveries less than 0.3 mg/dL or 5% over 3 days. | The total imprecision of uric acid recoveries over the test periods was less than 0.3 mg/dL or 5% over the claimed 3-day calibration stability period. |
2. Sample sizes used for the test set and the data provenance
- Linearity/Recovery: n = 30 (for regression statistics, representing standard values/recoveries). No information on provenance (e.g., country of origin, retrospective/prospective) is provided, but it pertains to the behavior of the reagent with known standard concentrations.
- Precision: n = 60 for each of the three serum control samples. This implies 60 replicate measurements for each control. No information on provenance for these commercially available control sera.
- Method Comparison: n = 120 (mixed serum and plasma specimens). No information on country of origin. The data provenance is described as "collected from adult patients," suggesting prospective or freshly collected samples for the purpose of the study.
- Detection Limit: n = 30 (for within-run precision study of a diluted serum pool).
- Reagent Stability: "serum controls" assayed over the claimed periods. Specific 'n' not given, but likely multiple measurements of controls.
- Calibration Stability: "serum controls" assayed over the claimed periods. Specific 'n' not given, but likely multiple measurements of controls.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a chemical assay, not an imaging device requiring expert interpretation. The "ground truth" for linearity and precision is based on known concentrations of standards and control materials. For method comparison, the "ground truth" is established by a "commercially available method" (the competitive reagent), and the goal is to show agreement between the two methods, rather than an expert ground truth.
4. Adjudication method for the test set
Not applicable. As noted above, this is a chemical assay.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a diagnostic reagent, not an AI-based system or an imaging device requiring human reader interpretation. No AI component is described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The performance data presented are for the "ATAC PAK Uric Acid Reagent Kit on the ATAC 8000 Random Access Chemistry System." This represents the standalone performance of the reagent kit and analyzer system in determining uric acid levels in samples. Human involvement is limited to operating the instrument, performing calibration/quality control, and interpreting quantitative numerical results provided by the system.
7. The type of ground truth used
- Linearity/Recovery: Known concentrations of "linearity standards."
- Precision: Assays of "commercially available control serum" with expected target ranges/values.
- Method Comparison: Results from a "commercially available method" (predicate device or similar). This serves as the reference for comparison, rather than an absolute "ground truth" in the sense of pathology or outcome data.
- Detection Limit: A "diluted serum pool" and its statistical properties.
- Stability Studies: "Serum controls" with known target values.
8. The sample size for the training set
Not applicable. This is a chemical reagent and analyzer system, not an algorithm that requires a "training set." The system's operation is based on established chemical principles and pre-programmed instrument parameters, not machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
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