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510(k) Data Aggregation
(155 days)
IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN
The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Urine Protein Calibrator, is intended for the quartitative determination of Immunoglobulin G in urine by rate nephelometry.
The IMMAGE Immunochemistry System Urine Immunoglobulin G (IGU) reagent, in coniunction with Beckman's Urine Protein Calibrator, is intended for use in the quantitative determination of Immunoglobulin G in human urine samples.
This document describes the IMMAGE™ Immunochemistry System Urine Immunoglobulin G (IGU) Reagent. The acceptance criteria and supporting study are outlined below:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (IMMAGE IGU Reagent) |
|---|---|
| Method Comparison (vs. Predicate Device) | |
| Slope should be close to 1.00 | 1.00 |
| Intercept should be close to 0.00 | 0.00 |
| Correlation coefficient (r) should be close to 1.00 (indicating strong linearity) | 0.998 |
| Stability | |
| Shelf-life | 24 months |
| Open container stability | 14 days |
| Calibration stability | 14 days |
| Within-Run Imprecision (as %CV) | |
| For Level 1 material | 10.2% |
| For Level 2 material | 2.7% |
| For Level 3 material | 2.7% |
Study Details
1. Sample sized used for the test set and the data provenance:
- Method Comparison Test Set Size: 115 samples.
- Data Provenance: Not specified; the document does not mention the country of origin or if the data was retrospective or prospective.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is an in-vitro diagnostic device measuring a biological analyte. The ground truth for method comparison is the measurement obtained from a predicate device, not expert consensus.
3. Adjudication method for the test set:
- Not applicable. As this is a quantitative analytical device, adjudication by experts for ground truth is not relevant. The comparison is against a well-established predicate device.
4. 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 an in-vitro diagnostic reagent, not an AI-assisted diagnostic tool that involves human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this study represents a standalone performance evaluation of the IMMAGE IGU Reagent system. Its performance is compared to a predicate device, and its stability and imprecision are assessed independently. The "algorithm" here refers to the nephelometric methodology of the IMMAGE system.
6. The type of ground truth used:
- Method Comparison: The ground truth for the method comparison study was established by measurements obtained from the Beckman Immunoglobulin G (IGG) Test System (Urine application), which is the predicate device.
- Stability and Imprecision: The ground truth for stability and imprecision studies would be based on established analytical reference methods and quality control materials for immunoglobulin G measurements.
7. The sample size for the training set:
- Not applicable. This document describes an in-vitro diagnostic reagent, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The development of such reagents relies on chemical and biological principles, not statistical learning from a dataset.
8. 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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