(29 days)
System reagent for the quantitative determination of ß-2-Microglobulin (ß-2-M) in human serum on Beckman Coulter AU analyzers. For In Vitro Diagnostic use only.
The Beta-2-Microglobulin reagent kit is a System Reagent for the Quantitative determination of ß-2-Microglobulin (ß-2-M) in human serum on Beckman Coulter AU analyzers. The ßeta-2-Microglobulin kit is a liquid, ready to use and consists of 4 x 10mL R1 reagent vials and 4 x 8mL R2 reagent vials. Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay. The ßeta-2-Microglobulin reagent is designed for optimal performance on Beckman Coulter AU analyzers.
The provided text describes the Beckman Coulter Beta-2-Microglobulin reagent, but it does not contain information about a study proving that a device meets acceptance criteria in the context of AI/ML or medical imaging analysis.
The document is a 510(k) summary for an in vitro diagnostic reagent used to measure Beta-2-Microglobulin in human serum. This type of product is different from a "device" in the context of AI/ML, which typically refers to software or hardware that assists in diagnosis or treatment based on complex data analysis (like image interpretation).
Therefore, I cannot provide an answer based on the detailed requirements you outlined, such as multireader multidevice studies, expert adjudication for ground truth, or training set details, as these are not relevant to the type of product described in the input.
However, I can extract the acceptance criteria and performance data that are present for this specific reagent:
Acceptance Criteria and Reported Reagent Performance (for Beta-2-Microglobulin Reagent)
| Acceptance Criteria Category | Specific Metric (Criteria) | Reported Reagent Performance |
|---|---|---|
| Stability | Reagent On-Board Stability | 90 days |
| Calibration Frequency | 90 days | |
| Analytical Performance | Specificity (Interferences) | Within ± 10 % NSI for: |
- Ascorbate 20 mg/dL
- Bilirubin 40 mg/dL
- Hemolysis 500 mg/dL
- Lipemia 500 mg/dL |
| | Dynamic Range / Linearity | 0.05 - 1.6 mg/dL |
| | Precision Within Run | ≤ 5% CV |
| | Precision Total | ≤ 10% CV |
Further details from the document (as far as applicable):
- Sample size used for the test set and data provenance: Not explicitly stated as "test set" in the context of an AI device. For stability testing, "one reagent lot" was used. The document refers to "human serum" generally for the intended use and does not specify geographical origin or if it was retrospective or prospective.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for a reagent. The "ground truth" for a reagent's performance is typically established through analytical methods and comparison to existing validated methods or reference materials.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a reagent.
- 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 for an in vitro diagnostic reagent, not an AI medical device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For analytical performance (e.g., linearity, precision), analytical validation is the ground truth (e.g., comparing results to known concentrations, reference methods, or statistical limits). The document mentions "controls" and "calibration" as part of the stability testing.
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable.
Study Proving Device Meets Acceptance Criteria:
The document describes a non-clinical study to demonstrate that the Beta-2-Microglobulin system reagent is as safe, effective, and performs as well as the predicate device.
- Study type: Analytical performance study, focusing on stability (on-board and calibration frequency).
- Methodology for Stability: "Testing was performed using one reagent lot. Calibration was performed on the first day. Controls were run to check calibration and the reagent. Linearity was run on the last number of shots of reagent. The maximum time point exceeded the claim. Calibration was performed again at day 90."
- Conclusion: The tests established a 90-day reagent on-board claim and a 90-day calibration frequency claim, indicating the proposed device meets the stability performance of the predicate.
- Other performance characteristics (Specificity (Interferences), Dynamic Range / Linearity, Precision Within Run, Precision Total): The table states "Similar" for the proposed device compared to the predicate, implying that these characteristics were either demonstrated to be equivalent through testing or are inherent to the described technology and formulation which are similar to the predicate. Specific details of how these were proven beyond "similar" are not provided in this summary but would be in the full submission.
In summary, the provided document details the analytical performance and stability of a laboratory reagent, not an AI or imaging device, thus many of your specific questions are not applicable.
§ 866.5630
Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.