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510(k) Data Aggregation
(22 days)
IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT
The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Calibrator 2, is intended for the quantitative determination of human Beta-2-Microglobulin in serum or plasma by rate nephelometry.
The IMMAGE® Immunochemistry System Beta-2-Microglobulin (B2MX) Reagent is designed for optimal performance on the IMMAGE® Immunochemistry Systems. It is intended for the quantitative determination of beta-2-microglobulin in serum or plasma.
Here's a breakdown of the acceptance criteria and the study information for the Beckman Coulter IMMAGE® Immunochemistry System Beta-2-Microglobulin Reagent, based on the provided text:
Acceptance Criteria and Device Performance
The provided document does not explicitly state "acceptance criteria" in a table format with pass/fail thresholds. Instead, it presents performance data for a method comparison study and an imprecision study to demonstrate substantial equivalence to a predicate device. The implied acceptance is that the device performs comparably to the predicate device and exhibits acceptable imprecision for its intended use.
Here's a table summarizing the reported device performance, with the understanding that these are the results that presumably met the underlying (unspecified) acceptance criteria for substantial equivalence:
| Performance Metric | Reported Device Performance (IMMAGE B2MX Reagent) | Implied Acceptance Criteria (relative to Predicate) |
|---|---|---|
| Method Comparison (vs. Array 360 Beta-2-Microglobulin) | Linear regression should demonstrate high correlation and agreement. | |
| Slope | 0.979 | Close to 1.0 |
| Intercept (mg/dL) | -0.017 | Close to 0.0 |
| Correlation Coefficient (r) | 0.996 | Close to 1.0 (indicating strong correlation) |
| Imprecision (Within-Run) | CV should be within clinically acceptable limits, and comparable to industry standards/predicate performance. | |
| Level 1 (0.10 mg/dL) | 10.0 %C.V. | Acceptable for low concentrations |
| Level 2 (1.84 mg/dL) | 2.3 %C.V. | Low %C.V. |
| Level 3 (3.19 mg/dL) | 1.9 %C.V. | Low %C.V. |
| Imprecision (Total) | CV should be within clinically acceptable limits, and comparable to industry standards/predicate performance. | |
| Level 1 (0.10 mg/dL) | 10.0 %C.V. | Acceptable for low concentrations |
| Level 2 (1.84 mg/dL) | 2.6 %C.V. | Low %C.V. |
| Level 3 (3.19 mg/dL) | 2.2 %C.V. | Low %C.V. |
Study Details
The provided document describes two main studies: a method comparison study and an imprecision study.
2. Sample Size and Data Provenance
- Test Set Sample Size (Method Comparison): 111 samples (for serum analytes)
- Data Provenance: Not explicitly stated, but clinical laboratory device studies for FDA submission typically use samples from a clinical population. The document does not specify country of origin or whether samples were retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. For this type of in vitro diagnostic device (IVD) studying an analyte's quantitative determination, ground truth is established by a reference method (the predicate device in this case) and traceable calibrators, not by expert interpretation.
4. Adjudication Method
- Not Applicable. No human interpretation or adjudication process is mentioned, as the study is a quantitative comparison of analytical methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not relevant for this type of IVD, which quantifies a biomarker. MRMC studies are typically used for imaging diagnostics or other modalities requiring human interpretation.
6. Standalone Performance (Algorithm Only)
- Yes. The studies present the analytical performance of the IMMAGE® Immunochemistry System Beta-2-Microglobulin Reagent as a standalone system. The results (slope, intercept, correlation, imprecision) directly reflect the algorithm's (reagent and instrument's) ability to measure the analyte without human interpretation in the results generation process.
7. Type of Ground Truth Used (Test Set)
- Reference Method / Predicate Device Output. The "ground truth" for the method comparison study was the results obtained from the predicate device, the Beckman Array® Beta-2-Microglobulin (B2M) on the Array 360 system.
8. Sample Size for Training Set
- Not explicitly stated/Not applicable in the same way as AI/ML. For IVD assay development, there isn't a "training set" in the machine learning sense. Instead, development involves experiments to optimize reagent formulation, calibration curves, and instrument parameters, which effectively "train" the assay to measure accurately. The document does not provide details on the number of samples used during this development/optimization phase.
9. How Ground Truth for Training Set Was Established
- Not applicable in the same way as AI/ML. For IVD assays, the "ground truth" during development is established through the use of characterized reference materials, calibrators with known concentrations, and comparison to established reference methods or primary standards, ensuring traceability and accuracy. The document does not detail this process but it is standard for IVD development.
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(44 days)
IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT
The IMMAGE Immunochemistry System Beta-2-Microglobulin (B2M) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human beta-2-microglobulin by rate nephelometry.
The IMMAGE Immunochemistry System B2M Reagent in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of beta-2-microglobulin concentrations in human serum samples on Beckman's IMMAGE Immunochemistry System.
The Beckman IMMAGE™ Immunochemistry System Beta-2-Microglobulin (B2M) Reagent is intended for the quantitative determination of human beta-2-microglobulin in serum by rate nephelometry. The study provided focuses on demonstrating substantial equivalence to a predicate device through method comparison, stability, and imprecision experiments, rather than establishing acceptance criteria against a specific clinical performance threshold.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for each performance metric. Instead, it presents the results of studies and implies that these results demonstrate substantial equivalence to the predicate device.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison | Demonstrate substantial equivalence to the predicate device | Data presented (though not fully legible in the provided snippet) suggests comparison to Array System Beta-2-Microglobulin reagent. The summary states "Equivalence is demonstrated through method comparison..." |
| Shelf-life Stability | Meet product claim | 24 month shelf-life |
| Open Container Stability | Meet product claim | 14 day open container stability |
| Calibration Stability | Meet product claim | 14 day calibration stability |
| Within-Run Imprecision | Low variability at different concentration levels (typical for IVD) | Level 1: Mean 0.34 mg/dL, SD 0.029 mg/dL, %CV 8.5 (N=80) |
| Level 2: Mean 1.65 mg/dL, SD 0.045 mg/dL, %CV 2.7 (N=80) | ||
| Level 3: Mean 3.43 mg/dL, SD 0.099 mg/dL, %CV 2.9 (N=80) |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison Study: The snippet of the table for method comparison is largely unreadable. It's impossible to determine the sample size from the provided text.
- Imprecision Study (Within-Run): A sample size of N=80 was used for each of the three levels tested.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Typically, such studies for device submission are prospective and conducted in clinical laboratory settings.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and study. The IMMAGE Immunochemistry System B2M Reagent is an in-vitro diagnostic (IVD) device that quantitatively measures a biomarker (Beta-2-Microglobulin). The "ground truth" for such devices is typically established by reference methods or validated comparative methods, not by expert consensus on visual interpretation.
4. Adjudication Method for the Test Set
This information is not applicable as it pertains to subjective interpretations or classifications, which is not the nature of this quantitative IVD device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices where human readers interpret medical images, often with and without AI assistance. The Beckman IMMAGE system is a laboratory instrument for quantitative biomarker measurement.
6. Standalone (Algorithm Only) Performance Study
The provided document describes the performance of the entire device system (reagent with the IMMAGE Immunochemistry System), not just an isolated algorithm. The "algorithm" in this context is the rate nephelometry methodology, which is an integral part of the measurement system. Therefore, a standalone algorithm-only performance study as understood in the context of AI tools is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by quantitative measurements derived from comparison to a predicate device (Array System Beta-2-Microglobulin (B2M) reagent) and through internal analytical performance studies (stability, imprecision). For quantitative assays, "ground truth" often refers to the true concentration of the analyte, frequently determined by validated reference methods or the performance of a legally marketed predicate device.
8. Sample Size for the Training Set
This information is not explicitly stated and is likely not applicable in the context of traditional IVD device development for chemical reagents and equipment. The IMMAGE Immunochemistry System B2M Reagent uses a nephelometric methodology. This is a physics-based measurement technique, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of such a system involves calibrating the instrument with known standards to establish a calibration curve. Sample preparation and testing involves real patient samples (test set), but not algorithm training.
9. How the Ground Truth for the Training Set Was Established
As explained above, there isn't a "training set" with established ground truth in the machine learning sense for this traditional IVD device. The calibration of the system would involve using known calibrator materials (e.g., Beckman Calibrator 2, mentioned in the Intended Use) with assigned values, which act as the "ground truth" for the instrument's calibration curve.
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