(125 days)
The IMMAGE Immunochemistry System Alpha-1-Microglobulin (A1M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of of alpha-1-microglobulin in urine by rate nephelometry.
The IMMAGE Immunochemistry System A1M Reagent in conjunction with Beckman Urine Protein Calibrator, is intended for use in the quantitative determination of alpha-1-Other Fotom Calibration is interesmples on Beckman's IMMAGE™ Immunochemistry System.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" with numerical targets in a formal table for the new device. Instead, it demonstrates substantial equivalence to a predicate device through various performance metrics. The implicit acceptance criteria are that the new device's performance should be comparable to or better than the predicate device.
| Performance Metric | Implicit Acceptance Criteria (Comparable to Predicate) | Reported Device Performance (IMMAGE A1M Reagent) |
|---|---|---|
| Method Comparison | ||
| Slope (vs. Predicate) | Close to 1.0 | 0.961 |
| Intercept (vs. Predicate) | Close to 0.0 | 0.10 |
| Correlation Coefficient (r) | High (close to 1.0) | 0.993 |
| Stability | Maintenance of performance over specified durations | |
| Shelf-Life | Comparable to predicate or acceptable for commercial use | 12-month shelf-life |
| Open Container Stability | Acceptable for laboratory use | 30-day open container stability |
| Calibration Stability | Acceptable for laboratory use | 30-day calibration stability |
| Imprecision (Precision) | Acceptable within-run and total imprecision for a diagnostic device | |
| Within-Run %C.V. (Level 1) | Low | 2.8% |
| Within-Run %C.V. (Level 2) | Low | 1.8% |
| Within-Run %C.V. (Level 3) | Low | 2.4% |
| Total %C.V. (Level 1) | Low | 4.1% |
| Total %C.V. (Level 2) | Low | 2.0% |
| Total %C.V. (Level 3) | Low | 2.9% |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size for Method Comparison: 123 urine samples were used for the method comparison study.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission for a new device, it is highly likely that the data was collected prospectively in a controlled laboratory setting, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable to this type of device and study. The IMMAGE A1M Reagent is a quantitative assay for alpha-1-microglobulin in urine. Ground truth for such assays is typically established by comparing results to a recognized reference method (in this case, the predicate Beckman Alpha-1-Microglobulin Reagent) or by using highly characterized samples with known concentrations. There are no "experts" in the sense of clinical reviewers establishing a diagnostic ground truth here, but rather a reference measurement system.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation of data (e.g., medical images) where multiple human readers contribute to establishing a consensus ground truth. For a quantitative chemical assay, the comparison is directly between the new device's numerical output and the predicate device's numerical output.
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. This document describes a chemical reagent system, not an AI-powered diagnostic tool requiring human interpretation or an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is effectively a standalone performance study. The IMMAGE A1M Reagent, as a laboratory assay, generates quantitative results directly from the sample without human "interpretation" of its output that would significantly alter the result. The study evaluates the performance of the reagent system itself.
7. The Type of Ground Truth Used:
The "ground truth" for the method comparison study was established by the predicate method, the Beckman Alpha-1-Microglobulin Reagent on the Array® 360 System. This is a common approach in demonstrating substantial equivalence for in vitro diagnostic (IVD) devices: showing that the new device's results correlate highly with a legally marketed, previously cleared device.
8. The Sample Size for the Training Set:
This information is not applicable as this describes a chemical reagent system, not a machine learning or AI-based device that requires a training set. The "training" for such a system involves the chemical formulation of the reagent and the instrument's calibration procedures.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as #8.
§ 866.5400
Alpha -globulin immunological test system.(a)
Identification. Analpha- globulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- globulin (a serum protein) in serum and other body fluids. Measurement ofalpha- globulin may aid in the diagnosis of inflammatory lesions, infections, severe burns, and a variety of other conditions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.