Search Results
Found 1 results
510(k) Data Aggregation
(176 days)
The ATAC Calcium Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitation of calcium in serum and plasma. Calcium results are for the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany (intermittent muscular contractions or spasms).
The ATAC Calcium Reagent Kit is intended for the quantitative determination of calcium in serum and plasma. Calcium results are for the diagnosis and treathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The ATAC Calcium Reagent determines calcium through binding by o-cresolphthalein complexone at alkaline pH. The resulting increase in absorbance at 578 nm is proportion al to the calcium concentration of the sample.
The provided text describes the ATAC Calcium Reagent Kit and studies demonstrating its performance. However, it does not explicitly define "acceptance criteria" as a set of specific thresholds for the reported performance metrics. Instead, it presents the results of various validation studies and implicitly suggests that these results are deemed acceptable for the device's intended use and demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided information, framed to address your request for acceptance criteria and the supporting study, even if the "acceptance criteria" are implied rather than explicitly stated.
Interpretation of Acceptance Criteria:
Given that this is a 510(k) submission, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence to a predicate device (HiChem™ Calcium Reagent Kit) and proving that the device performs safely and effectively for its intended use. While explicit numerical cut-offs aren't listed as "acceptance criteria," the reported performance metrics in the studies are implicitly deemed acceptable by the manufacturer for this purpose.
1. Table of Acceptance Criteria and Reported Device Performance
Note: As explicit "acceptance criteria" are not provided, the table below lists the performance parameters evaluated and their reported results. The implied acceptance is that these results are clinically acceptable and demonstrate substantial equivalence to the predicate device.
| Performance Parameter | Implied Acceptance Criteria (based on common IVD standards and predicate equivalence) | Reported Device Performance (ATAC Calcium Reagent Kit) |
|---|---|---|
| Linearity/Recovery | Demonstrated linearity across the usable range; high correlation (r > 0.99) | Linear from 0.2 to 15 mg/dL; r = 0.9984; (ATAC Recoveries) = 1.069 x (Standard Value); sy.x = 0.32 mg/dL; n = 21 (for regression) |
| Precision (Within Run) | Low %CV for different serum levels (e.g., < 2-3%) | Serum 1 (7.4 mg/dL): 1SD = 0.11 mg/dL, %CV = 1.4% Serum 2 (10.4 mg/dL): 1SD = 0.20 mg/dL, %CV = 1.9% Serum 3 (13.2 mg/dL): 1SD = 0.17 mg/dL, %CV = 1.3% |
| Precision (Total) | Low %CV for different serum levels (e.g., < 2-3%) | Serum 1 (7.4 mg/dL): 1SD = 0.14 mg/dL, %CV = 1.9% Serum 2 (10.4 mg/dL): 1SD = 0.21 mg/dL, %CV = 2.0% Serum 3 (13.2 mg/dL): 1SD = 0.23 mg/dL, %CV = 1.8% |
| Method Comparison (Correlation with Competitive Reagent) | Strong correlation (r > 0.95) and good agreement with a predicate or established method | ATAC 8000 = 0.7 mg/dL + 0.944 x Competitive Reagent; r = 0.942; n = 120; range = 6.4 - 11.5 mg/dL |
| Detection Limit | Ability to detect low clinically relevant concentrations | 0.2 mg/dL (documented by repetitive assay of a diluted serum pool; SD of 30 replicates was 0.05 mg/dL) |
| Reagent Stability (On-board) | Demonstrated stability for claimed period; imprecision within acceptable limits | 14-day stability documented; total imprecision of calcium recoveries over test period was < 0.2 mg/dL or 2% |
| Calibration Stability | Demonstrated stability for claimed period; imprecision within acceptable limits | 4-hour stability documented; total imprecision of calcium recoveries over test period was < 0.2 mg/dL or 2% |
Details of the Study Proving Device Meets Acceptance Criteria:
The provided document describes a series of studies performed to demonstrate the safety and effectiveness, and specifically the substantial equivalence, of the ATAC Calcium Reagent Kit to a legally marketed predicate device (HiChem™ Calcium Reagent Kit).
2. Sample Size Used for the Test Set and Data Provenance:
- Linearity Study:
- Sample Size: n = 21 (number of regression points/standards).
- Data Provenance: Not explicitly stated, but likely laboratory-prepared linearity standards.
- Precision Study:
- Sample Size: n = 60 for each of the three serum control levels (total 180 individual measurements for precision). These 60 measurements were likely split across two instruments as mentioned ("on two separate instruments").
- Data Provenance: Commercially available control serum.
- Method Comparison Study:
- Sample Size: n = 120 patient specimens.
- Data Provenance: Mixed serum and plasma specimens collected from adult patients. The country of origin is not specified but is presumably the US, given the FDA submission. This is a prospective or retrospective collection of patient samples, but the method comparison itself is a prospective analysis.
- Detection Limit Study:
- Sample Size: 30 replicates for a within-run precision study.
- Data Provenance: A diluted serum pool.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For in vitro diagnostic devices like reagent kits, "ground truth" is typically established by:
- Using reference materials (e.g., for linearity).
- Using validated control materials with known target values (e.g., for precision).
- Comparing against a predicate device or a well-established, clinically accepted method (e.g., for method comparison).
- Pathology or outcome data are not directly applicable here as it's a quantitative measurement of a biomarker.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in imaging studies where subjective interpretation by multiple readers is involved to establish a consensus ground truth. For a quantitative chemistry assay, the "ground truth" for validation is based on the inherent properties of the reference materials/controls or the results from a comparison method.
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:
This information is not applicable and therefore not provided. MRMC studies are specific to imaging and AI-assisted interpretation, where human readers interact with AI. The ATAC Calcium Reagent Kit is a standalone chemical assay, not an imaging device or an AI-powered diagnostic tool requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are solely for the standalone performance of the ATAC Calcium Reagent Kit on the ATAC 8000 Random Access Chemistry System. There is no human-in-the-loop component in the "performance" described; it's the analytical performance of the reagent and instrument system.
7. The Type of Ground Truth Used:
- For Linearity: The ground truth was established by standard values of linearity standards.
- For Precision: The ground truth was established by the labeled target values of commercially available control serum.
- For Method Comparison: The ground truth was effectively established by the results from a "competitive reagent" (another commercially available method), which serves as the reference method in this comparison to demonstrate substantial equivalence.
- For Detection Limit: The ground truth was established by the known dilution of a serum pool and the statistical variation measured at that low concentration.
8. The Sample Size for the Training Set:
This information is not applicable and therefore not provided. This device is a chemical reagent, not a machine learning or AI model that requires a "training set" in the computational sense. The "development" or "optimization" of such a reagent kit might involve many experiments, but these are not referred to as a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" in the context of this device.
Ask a specific question about this device
Page 1 of 1