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For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or EDTA plasma using the ADVIA Centaur® System. This diagnostic test is designed to quantitatively measure HCY in serum or EDTA plasma. Such measurement can aid in the diagnosis and treatment of patients suspected of having homocystinuria or hyperhomocysteinemia.

The ADVIA Centaur HCY assay is a competitive immunoassay using direct, The rib vir connecessent technology. It is intended to measure the amino acid Homocysteine (HCY) in serum or EDTA plasma. The homocysteine assay requires four separate reagents, which are added sequentially. A Reducing Reagent releases four separato reagence, willer in a sample or control to free HCY. A Enzyme provem uses the enzyme S-adenosylhomocysteine hydrolase to convert the free HCY to S-adenosylhomocysteine (SAH). SAH from a calibrator, control, or sample to S-adenosyinomes Josent (ethe Solid Phase for binding to a monoclonal anti SAH antibody-acridinium ester conjugate in the Lite Reagent. Following incubation, unbound SAH and anti SAH-acridinium ester conjugate are washed from the Solid Phase. The chemiluminescence of the acridinium ester bound to the Solid Phase is I has . The enemaint of chemiluminescence is inversely proportional to the amount of HCY that was present in the sample.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ADVIA Centaur HCY Assay:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state pre-defined acceptance criteria in terms of thresholds for R-value, slope, or intercept. Instead, it presents the results of a method comparison study and infers acceptance based on substantial equivalence to the predicate device. However, based on the provided results, we can infer the achieved performance in comparison to the predicate.

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

• Sample Size: 106 samples.
• Data Provenance: The document does not specify the country of origin for the samples, nor whether they were retrospective or prospective. It simply states "106 samples were assayed on both systems."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. For an immunoassay device, the "ground truth" is typically another established, well-validated method. The study described is a method comparison, where one method (the predicate) serves as the reference, rather than requiring expert adjudication of individual cases.

4. Adjudication Method for the Test Set:

This information is not applicable/provided for this type of immunoassay method comparison study. Adjudication methods (like 2+1 or 3+1) are typically used in imaging or diagnostic studies where human experts interpret ambiguous results to establish a consensus ground truth. In this case, the results from the predicate device (Abbott IMx Homocysteine assay) are implicitly treated as the reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human reader performance, which is not relevant for a standalone immunoassay device like the ADVIA Centaur HCY Assay.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, the described study assesses the standalone performance of the ADVIA Centaur HCY Assay. It compares the quantitative results produced solely by the ADVIA Centaur system against those from the predicate Abbott IMx system, without any human interpretation or intervention in the measurement process itself.

7. The Type of Ground Truth Used:

The "ground truth" for this study was established by comparison to a legally marketed predicate device, specifically the Abbott IMx Homocysteine assay. The IMx assay's results served as the reference standard against which the ADVIA Centaur HCY assay's performance was evaluated.

8. The Sample Size for the Training Set:

This information is not provided in the document. Immunoassays are typically developed through a process of reagent formulation, calibration, and optimization rather than "training" in the machine learning sense with a specific training set. The term "training set" is generally not applicable to the development of this type of diagnostic assay.

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

This information is not provided and is generally not applicable in the context of traditional immunoassay development as described in the document. The development involves analytical validation, calibration against known standards, and optimization of reagents and protocols, rather than establishing "ground truth" from a training set of patient samples in the same way machine learning models are trained.

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