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The AxSYM® Homocysteine assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of total L-homocysteine in human serum or plasma on the AxSYM System. Homocysteine values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

AxSYM Homocysteine is a Fluorescence Polarization Immunoassay for the quantitative r ate volument of total L-homocysteine in human serum or plasma on the AxSYM System. AxSYM Homocysteine is calibrated with Abbott Homocysteine Calibrators. Abbott Homocysteine Controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.

The provided text describes the Abbott AxSYM® Homocysteine assay, which is a Fluorescence Polarization Immunoassay for the quantitative measurement of total L-homocysteine in human serum or plasma. The 510(k) submission seeks to demonstrate substantial equivalence to the previously cleared Abbott IMx® Homocysteine assay.

Here's an analysis 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 core of the acceptance criteria for this 510(k) submission is demonstrating substantial equivalence to a predicate device, the Abbott IMx® Homocysteine assay. This is primarily evaluated through a comparison of analytical performance, specifically correlation.

Based on these results, the AxSYM Homocysteine assay demonstrated strong agreement with the predicate IMx Homocysteine assay, satisfying the implicit acceptance criteria for substantial equivalence through analytical comparison. The correlation coefficients are very high (0.985), and the slopes are close to 1.0 with y-intercepts close to 0, indicating a high degree of concordance between the two methods.

2. Sample Size and Data Provenance

• Sample Size for Test Set: 300 specimens were used for the comparative study between the AxSYM Homocysteine assay and the IMx Homocysteine assay.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: This information is not provided in the text.
• Qualifications of Experts: This information is not provided in the text.

(It's important to note that for a diagnostic assay like this, "ground truth" often refers to the consensus of a reference method or a previously validated device, rather than the consensus of human experts interpreting images or complex qualitative data.)

4. Adjudication Method for Test Set

• Adjudication Method: This information is not provided in the text. Given that the ground truth appears to be comparison against a predicate device's results, a typical human-expert adjudication method (like 2+1 or 3+1) would not be applicable in this context. The "adjudication" is essentially the statistical comparison of the two assay results.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for imaging or qualitative diagnostic devices where human interpretation plays a significant role. The Abbott AxSYM® Homocysteine is an automated quantitative immunoassay, where the output is numerical and does not involve human readers in the same way.
• Effect Size of Human Readers Improvement: Not applicable, as an MRMC study was not performed.

6. Standalone Performance Study

• Standalone Performance: Yes, the essence of the 510(k) submission is to demonstrate the standalone performance of the new AxSYM Homocysteine assay by comparing its output (algorithm only) directly against the predicate IMx Homocysteine assay's output (algorithm only). The statistical analyses (least squares and Passing-Bablok regressions) directly assess the agreement between the two automated systems without human intervention in the result generation. The statement "Substantial equivalence has been demonstrated between the AxSYM Homocysteine assay and the Abbott IMx® Homocysteine assay" directly supports this.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context is the results obtained from the predicate device, the Abbott IMx® Homocysteine assay. The study aims to show that the new device produces results that are substantially equivalent to those of the predicate. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices when a well-established and legally marketed predicate device exists.

8. Sample Size for the Training Set

• Sample Size for Training Set: This information is not provided in the text. It's common for such submissions to focus on validation (test set) data, assuming the method was developed using appropriate internal training data.

9. How Ground Truth for Training Set Was Established

• How Ground Truth for Training Set Was Established: This information is not provided in the text. Similar to point 8, the text focuses on the validation of the device against a predicate, not on the internal development and training of the assay.

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