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The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, lithium heparin plasma, and red blood cells using the Access Immunoassay Systems. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.

Folate levels in serum, lithium heparin plasma, and red blood cells are used to assess folate status. The serum folate levels is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency.

The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum and lithium heparin plasma or red blood cells using the Access Immunoassay Systems.

The provided text describes the Beckman Coulter Access Folate Assay, a chemiluminescent immunoassay for the quantitative determination of folic acid levels. The submission is a 510(k) premarket notification for demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and supporting studies based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Method Comparison: 123 samples. Data provenance is not specified (e.g., country of origin, retrospective/prospective).
• Linearity: The number of samples/levels used is not explicitly stated, but it's a verification study.
• Serum Imprecision: 5 serum samples with varying concentrations. Each sample was assayed in duplicate with two runs per day, over 20-22 days, meeting a minimum requirement of 80 replicates per sample on each instrument and reagent lot combination. This implies a total of (5 samples * 80 replicates/sample) = 400 replicates (for one instrument and reagent lot combination, multiplied by 3 instruments and 3 reagent lots, so 3600 replicates in total across all combinations). Data provenance is not specified.
• RBC Imprecision: 6 whole blood hemolysate samples with varying concentrations. For each sample, N=80 replicates were collected for imprecision calculations. Data provenance is not specified.
• LoB/LoD/LoQ: Verification studies were performed but sample sizes are not explicitly stated, though CLSI EP17-A2 is mentioned as the protocol, which specifies methodologies for determining these limits.

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

Not applicable. This is a laboratory diagnostic assay for measuring analyte concentrations, not an interpretation task typically requiring expert consensus on ground truth like image analysis. The "ground truth" for method comparison and imprecision studies typically refers to the reference method (predicate device) results and the true concentration of controls/samples, respectively.

4. Adjudication Method for the Test Set

Not applicable. As this is a quantitative laboratory assay, there is no expert adjudication process in the traditional sense. The comparisons are against the predicate device or established analytical performance criteria.

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

No. This is an in-vitro diagnostic device (IVD) that quantitatively measures a biomarker (folic acid). MRMC studies are typically performed for devices that involve human interpretation, such as imaging devices, to evaluate the impact of AI assistance on reader performance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, the studies described (Method Comparison, Linearity, Imprecision, LoB/LoD/LoQ) demonstrate the standalone performance of the Access Folate Assay on the DxI 9000 Access Immunoassay Analyzer. This device is an automated immunoassay system; its output is a quantitative measurement, not an interpretation that involves human-in-the-loop interaction in the same way as, for example, an AI-powered diagnostic imaging tool. The "performance" refers to the analytical accuracy, precision, and range of the automated system itself.

7. Type of Ground Truth Used

• Method Comparison: The predicate device's results (Access Folate assay on Access 2 Instrument) served as the comparator for showing substantial equivalence.
• Linearity, Imprecision, LoB/LoD/LoQ: The "true" concentrations of control materials and samples, as determined by highly controlled experimental conditions and accepted statistical methods (e.g., CLSI guidelines), serve as the basis for evaluating performance against pre-defined analytical criteria.

8. Sample Size for the Training Set

The document does not provide information about a "training set." This type of IVD, an immunoassay, is typically developed and characterized through analytical verification and validation studies rather than machine learning training sets. While there is an "algorithm" (the immunoassay process), it's based on chemical reactions and detection, not a learned model from a large dataset. Therefore, the concept of a training set as used in AI/ML is not directly applicable here.

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

Not applicable, as a training set, in the machine learning sense, is not described for this device.

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