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510(k) Data Aggregation
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Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. This assay is capable of providing 3rd generation TSH results.
The Access TSH (3rd IS) Calibrators are intended to calibrate the Access TSH (3rd IS) assay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems.
The Access TSH (3rd IS) Assay (standardized to WHO 3rd International Standard, 81/565), Access TSH (3rd IS) Calibrators, and the Access Immunoassay analyzers comprise the Access Immunoassay System for the quantitative determination of thyroid-stimulating hormone (thyrotropin, TSH, hTSH) in human serum and plasma.
The provided text describes a 510(k) premarket notification for a medical device: "Access TSH (3rd IS) Assay and Access TSH (3rd IS) Calibrators on the Access Immunoassay Systems." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study design and results against specific acceptance criteria for a novel AI/ML-driven diagnostic device.
Therefore, many of the typical acceptance criteria and study design elements requested in your prompt (e.g., sample sizes for training/test sets in AI/ML, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not directly applicable or discussed in this type of submission. This document describes a traditional in-vitro diagnostic (IVD) assay, not an AI/ML device.
However, I can extract the closest equivalent information based on the provided text, interpreting "acceptance criteria" as performance specifications and "study" as the validation studies performed for this IVD device.
Acceptance Criteria and Reported Device Performance (Table)
While formal "acceptance criteria" are not presented as such for an AI/ML model, the document details various performance characteristics and their achieved results. The "Predicate" column can be seen as a de facto benchmark or comparison point for substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implied/Predicate) | Reported Device Performance (Access TSH (3rd IS) Assay) |
|---|---|---|
| Method Comparison (vs. Predicate) | Slope: 0.95 ± 0.10 (specification) | Slope: 0.94 (95% CI: 0.92 to 0.97) |
| Intercept: Not explicitly stated as criterion | Intercept: -0.02 µIU/mL | |
| Correlation Coefficient (r): Not explicitly stated as criterion | r = 0.99 | |
| Imprecision (Total CV) | ≤ 10% CV for concentrations > 0.02 µIU/mL | 3.1 to 6.3 %CV at all TSH concentrations |
| Imprecision (Total SD) | ≤ 0.0029 SD at concentrations ≤ 0.02 µIU/mL | 0.0008 to 0.0015 µIU/mL at TSH concentrations ≤ 0.02 µIU/mL |
| High-dose Hook Effect | No significant hook effect expected below high concentration | No high-dose hook effect up to at least 1,000 µIU/mL |
| Linearity | Linear across the assay range | Linear across 0.01 to approximately 50.0 µIU/mL |
| Dilution Recovery | Average recovery of 100 ± 10% for 10-fold dilution | Average recovery of 100 ± 10% when diluted 10-fold (50-500 µIU/mL) |
| Limit of Blank (LoB) | Not explicitly stated as criterion |
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