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510(k) Data Aggregation
(127 days)
The ATAC Creatinine 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 creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal dialysis and as a calculation basis for measuring other urine analytes.
The ATAC PAK Creatinine Reagent Kit is intended for the quantitative determination of creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes. The ATAC PAK Creatinines creatinine through the reaction of creatinine with alkaline picrate. The initial rate of absorbance increase at 510 nm is proportional to the creatinine concentration of the sample.
The provided text describes the ATAC PAK Creatinine Reagent Kit and its performance characteristics. This is a medical device for in vitro diagnostic use, specifically a reagent kit for measuring creatinine levels. The information presented is typical for a 510(k) submission, demonstrating substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of in vitro diagnostic device (reagent kit), regulatory acceptance criteria typically revolve around accuracy, precision, linearity, and stability, often in comparison to a legally marketed predicate device. The document does not explicitly state "acceptance criteria" but rather presents the results of studies designed to demonstrate the device's performance.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Linearity | Creatinine recovery should be linear across the usable range. | Linear from 0.2 to 25 mg/dL. Regression statistics forced through origin: (ATAC Recoveries) = 0.997 x (Standard Value), Sy.x = 0.19 mg/dL. |
| Precision | Demonstrated by replicate assay of control serum. (Implicitly, comparable to predicate). | Serum 1 (0.7 mg/dL): Within Run 1SD = 0.05, %CV = 6.9%; Total 1SD = 0.05, %CV = 7.4% Serum 2 (4.1 mg/dL): Within Run 1SD = 0.06, %CV = 1.6%; Total 1SD = 0.10, %CV = 2.5% Serum 3 (7.2 mg/dL): Within Run 1SD = 0.18, %CV = 2.5%; Total 1SD = 0.24, %CV = 3.3% Urine 1 (3.6 mg/dL): Within Run 1SD = 0.10, %CV = 2.8%; Total 1SD = 0.12, %CV = 3.3% Urine 2 (14.8 mg/dL): Within Run 1SD = 0.42, %CV = 2.9%; Total 1SD = 0.60, %CV = 4.0% |
| Method Comparison | Results should correlate well with a commercially available method for serum/plasma and urine. | Serum/Plasma: ATAC 8000 = 0.07 mg/dL + 0.956 x Competitive Reagent, r = 0.998 Urine: ATAC 8000 = 0.02 mg/dL + 0.960 x Competitive Reagent, r = 0.998 |
| Calibration Stability | Total imprecision of creatinine recoveries over the claimed period should be low. | Total imprecision < 0.2 mg/dL or 5% over 24-hour calibration. |
| Reagent Stability | Total imprecision of creatinine recoveries over the claimed period should be low. | Total imprecision < 0.2 mg/dL or 5% over 7-day reagent stability. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Linearity Study: n = 27 (number of standard recoveries used for regression).
- Precision Study: n = 120 for each of the 5 samples (3 serum controls, 2 urine pools). It's explicitly stated as "replicate assay," implying prospective measurement of specific control materials.
- Method Comparison (Serum/Plasma): n = 200 mixed serum/plasma specimens from adult patients. The data is prospective, collected by assaying specimens using both the ATAC 8000 and another commercial method. The origin is not explicitly stated, but given the company's US address, it's likely US-based, though not definitively provided.
- Method Comparison (Urine): n = 96 diluted urine specimens from adult patients. Prospective data, similar to the serum/plasma comparison, with likely US origin.
- Stability Studies: Not explicitly stated, but involved assaying "serum controls and urine pools over the claimed periods."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and study. The "ground truth" for creatinine measurement is established by the analytical method itself, often through internal calibrators traceable to a reference standard (though not explicitly stated for this kit, it's standard practice). The comparison is against another commercially available, validated method. There are no human experts "establishing ground truth" in the diagnostic interpretation sense for a biochemical reagent kit.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device and study. Adjudication processes (like 2+1, 3+1) are used in studies where human interpretation of data (e.g., images, clinical findings) is involved and a consensus "ground truth" needs to be established. For a quantitative chemical assay, the comparison is directly between the numerical results of two different analytical methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic imaging devices or other interpretation-based devices where human readers assess cases. This document describes the analytical performance of a reagent kit.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the studies described are standalone performance evaluations of the ATAC PAK Creatinine Reagent Kit used on the ATAC 8000 Random Access Chemistry System. These are "algorithm only" in the sense that they evaluate the analytical performance of the chemical reaction and the instrument's measurement capabilities, not involving human interpretation or decision-making as a primary performance metric beyond standard laboratory practices.
7. The Type of Ground Truth Used
- Linearity: The "ground truth" was established by standard values (known concentrations of creatinine standards).
- Precision: The "ground truth" was the mean concentration determined for commercially available control serum and urine pools.
- Method Comparison: The "ground truth" for comparison was the measurements obtained from an established, commercially available reference method (the "Competitive Reagent"). This is a form of comparative ground truth, where the new method is validated against an accepted one.
8. The Sample Size for the Training Set
This information is not explicitly provided in the document. For chemical reagent kits, there isn't typically a "training set" in the machine learning sense. Instead, development and optimization would involve numerous studies (assay development, formulation testing, preliminary performance runs) leading to the final reagent formulation and instrument protocol, but these aren't usually presented as a distinct "training set" in regulatory submissions. The studies presented are validation studies.
9. How the Ground Truth for the Training Set was Established
As there isn't a "training set" as understood in machine learning contexts for this type of device, this question is not applicable. The "ground truth" for developing a chemical assay is built upon fundamental chemical principles, analytical accuracy provided by known standards, and optimization processes to ensure proper reaction kinetics and measurement properties.
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