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The SYNCHRON LX Systems Immunoglobulin G (Ig-G) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin G in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

The SYNCHRON LX Systems Immunoglobulin A (Ig-A) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin A in serum or plasma. This assay is designed for use with dinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

The SYNCHRON LX Systems Immunoglobulin M (Ig-M) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin M in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

The SYNCHRON LX™ Systems Immunoglobulin G, A, and M (Ig-G, Ig-A, Ig-M) Reagents in conjunction with SYNCHRON LX Calibrator 1, are intended for use on Beckman's SYNCHRON LX Clinical Systems.

The provided 510(k) summary describes the SYNCHRON LX™ Systems Immunoglobulin G, A, & M Reagents. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices. The performance data focuses on method comparison, imprecision, and stability studies.

Here's an analysis of the acceptance criteria and study data based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance metrics in a formal, separate table. However, equivalence is demonstrated by comparing the new device's performance to the predicate devices through method comparison studies. The implicit acceptance criteria for method comparison would be a strong correlation (r-value close to 1) and a slope close to 1 with an intercept close to 0, indicating a close agreement with the predicate. For imprecision, lower Coefficients of Variation (CV%) indicate better precision. Stability claims are also presented, which serve as performance claims that must be met.

Note: The specific numerical acceptance criteria for slope, intercept, and r-value are not explicitly stated in the document, but are generally understood in the context of method comparison studies for medical devices. The reported r-values (0.9970, 0.9962, 0.9914) are very high, demonstrating strong correlation. The slopes are close to 1, and intercepts are relatively small compared to the typical ranges of these analytes, suggesting good agreement.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Sizes for Method Comparison (Test Set):

  • Ig-G Reagent: n = 82
  • Ig-A Reagent: n = 78
  • Ig-M Reagent: n = 72
    These numbers represent individual patient samples used to compare the new device's results against the predicate method.

• Data Provenance: The document does not explicitly state the country of origin. Given that Beckman Instruments, Inc. is based in Brea, California, and the submission is to the FDA, it is highly probable the data was generated in the United States. The studies are retrospective in the sense that they are comparing the performance of a new reagent to an existing, already commercialized predicate method on collected samples, rather than a prospective clinical trial with patient outcomes.

3. Number of Experts and Qualifications for Ground Truth

This type of submission (reagents for quantitative determination of immunoglobulins) does not typically involve human expert interpretation of images or clinical assessments to establish ground truth. The "ground truth" for the test set is established by the results obtained from the predicate device (Beckman's Immunoglobulin IGG, IGA, IGM Reagents), which are already considered established and accurate. Therefore, no external experts are used for ground truth determination in this context.

4. Adjudication Method

Not applicable. As described above, no human expert interpretation requiring adjudication is involved. The comparison is against an established quantitative assay.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC comparative effectiveness study is not relevant for this type of in-vitro diagnostic (IVD) reagent. These studies are typically performed for imaging devices or software that assist human readers in diagnosis. This submission is for a quantitative assay that directly measures immunoglobulin levels.

6. Standalone Performance Study

Yes, in a sense. The method comparison, imprecision, and stability studies demonstrate the standalone analytical performance of the SYNCHRON LX™ Systems Immunoglobulin reagents. This means the algorithm (the reagent and instrument system) is evaluated on its own ability to accurately and precisely measure the target analytes. There is no "human-in-the-loop" aspect to this type of assay in the way it would apply to AI-assisted diagnostics.

7. Type of Ground Truth Used

The ground truth for the method comparison studies is the quantitative results obtained from the predicate device's established method. For imprecision, the ground truth is the true concentration of the control samples used, and the goal is to show consistency around that true value. For stability, the ground truth is that the reagent should maintain its performance within acceptable limits over the claimed storage and operational periods.

8. Sample Size for the Training Set

The document does not specify a "training set" in the context of machine learning or AI algorithms. This is an IVD reagent submission, not an AI/ML device. The development of such reagents involves extensive R&D and optimization, but the concept of a "training set" as used in AI is not applicable here.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the AI/ML sense for this type of device. The development and optimization of the reagent formulations and assay parameters are based on standard biochemical and analytical chemistry principles, aiming to accurately and precisely quantify immunoglobulins.

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