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The ARCHITECT® Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay used for the quantitative determination of folate in human serum, plasma, and red blood cells on the ARCHITECT i System. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.

The ARCHITECT Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum, plasma, and red blood cells. The ARCHITECT Folate assay is calibrated with ARCHITECT Folate Calibrators. ARCHITECT Folate Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT i System.

The Abbott ARCHITECT Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum, plasma, and red blood cells. The study aimed to demonstrate its substantial equivalence to the legally marketed predicate device, the Bio-Rad Quantaphase II® B12/Folate Radioassay.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by achieving a strong correlation and acceptable slope and intercept values compared to the predicate device. The study demonstrates the correlation between the ARCHITECT Folate assay and the Bio-Rad Quantaphase II® B12/Folate Radioassay. While specific numerical acceptance criteria (e.g., minimum 'r' value, acceptable ranges for slope and intercept) are not explicitly stated, the reported values are presented as evidence of substantial equivalence.

Note: The implicit acceptance criteria are derived from the objective of demonstrating "substantial equivalence" through correlation analysis with a predicate device. Ideally, a slope close to 1 and an intercept close to 0 indicate good agreement. While the whole blood intercept values are large, correlation coefficients are identical.

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

• Sample Size:
  • Serum: 241 specimens
  • Whole Blood: 244 specimens
• Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, whether retrospective or prospective).

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

This study does not involve expert readers establishing ground truth as it is a quantitative assay comparing to a predicate device. The "ground truth" is effectively the results obtained from the predicate device.

4. Adjudication Method for the Test Set

Not applicable. This is a comparison of two quantitative laboratory assays, not a diagnostic imaging study requiring expert adjudication. The comparison is based on numerical results from both assays.

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

Not applicable. This is a study comparing the performance of a new laboratory assay to a predicate assay, not an AI-assisted diagnostic imaging study involving human readers.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The correlation analysis directly measures the performance of the ARCHITECT Folate assay (algorithm only, without human-in-the-loop) against the predicate device. The assay itself is a standalone measurement system.

7. Type of Ground Truth Used

The "ground truth" in this context is the quantitative folate measurements obtained from the legally marketed predicate device, the Bio-Rad Quantaphase II® B12/Folate Radioassay.

8. Sample Size for the Training Set

The provided information pertains to the performance study (test set) for substantial equivalence. It does not mention a separate "training set" for the ARCHITECT Folate assay, suggesting that the assay's methodology and calibration were established prior to this comparison study. For in vitro diagnostic devices, a training set often refers to samples used during the development and optimization of the assay's reagents, protocols, and instrument parameters, which is not detailed here.

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

Not applicable, as a distinct "training set" with established ground truth in the manner of AI/machine learning studies is not described for this type of in vitro diagnostic assay comparison. The assay's development and calibration would have followed standard laboratory best practices and validation, likely using reference materials and characterized samples, but this information is not provided in the summary.

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The Abbott ARCHITECT™ Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum, plasma, and red blood cells on the Abbott ARCHITECT™ i System. Measurements obtained by this device aid in the diagnosis and treatment of megaloblastic anemia.

The ARCHITECT Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum, plasma, (tripotassium EDTA, lithium heparin, or sodium heparin) and red blood cells (tripotassium EDTA). The ARCHITECT Folate assay is calibrated with Abbott ARCHITECT Folate Calibrators. Abbott ARCHITECT Folate Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i System.

Here's an analysis of the provided text regarding the Abbott ARCHITECT™ Folate assay, structured to address your specific questions about acceptance criteria and study details:

Acceptance Criteria and Study Details for Abbott ARCHITECT™ Folate

The Abbott ARCHITECT™ Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay for the quantitative determination of folate. The presented study aimed to demonstrate substantial equivalence to a legally marketed predicate device, the BioRad Quantaphase II Folate Radioassay. The primary method for demonstrating this was through correlation studies using patient samples.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the statistical measures of correlation and agreement between the new device and the predicate device. While explicit "acceptance criteria" are not numerically stated beforehand (e.g., "r > 0.95"), the reported statistics (correlation coefficient, slope, and intercept with 95% confidence intervals) are the performance measures that the FDA accepted as demonstrating substantial equivalence. The FDA letter confirms the device was found substantially equivalent.

Note on Interpretation:

• For the Least Squares regression, a slope of 1 and an intercept of 0 would indicate perfect agreement. The reported values for serum (slope 0.97, intercept 0.44) and whole blood (slope 1.00, intercept 36.04) are generally close to these ideals, especially considering their 95% confidence intervals.
• Passing-Bablok regression is often preferred for method comparison studies as it is robust against outliers and does not assume errors only in one method. The slopes of 1.08 and 1.14, and intercepts of -0.18 and -18.83, also demonstrate good agreement, though a slight proportional and constant bias can be inferred from the deviations from 1 and 0, respectively. However, given the high correlation and the FDA's acceptance, these were deemed acceptable.

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

• Sample Sizes:
  • Serum: n = 333
  • Whole Blood (referred to as "red blood cells" in other parts of the document): n = 160
• Data Provenance: Not explicitly stated (e.g., country of origin). The study details do not specify if the data was retrospective or prospective. Given the nature of method comparison studies at the time, it's common for them to be prospective clinical samples collected for the purpose of the study.

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

N/A - This device is an in vitro diagnostic (IVD) assay for quantitative determination of a biomarker (folate). "Ground truth" is established by the analytical result of the predicate device (BioRad Quantaphase II Folate Radioassay) on the same samples, not by expert interpretation. Therefore, experts are not used in this context to establish ground truth.

4. Adjudication Method for the Test Set

N/A - Adjudication methods (like 2+1, 3+1) are relevant for studies where subjective interpretation (e.g., by radiologists) is being evaluated and discrepancies need to be resolved. This is a method comparison study for an IVD, so "adjudication" in that sense is not applicable. The comparison involves direct quantitative measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This study is an analytical method comparison for an in vitro diagnostic device, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a sense, a "standalone" evaluation was performed. The ARCHITECT Folate assay (the "algorithm/device") directly measured folate levels in samples, and these results were compared to the standalone results of the predicate device. There is no human-in-the-loop component in the measurement process itself for either the new device or the predicate. The performance reported (correlation, slope, intercept) is the performance of the device itself.

7. The Type of Ground Truth Used

The "ground truth" for this method comparison study is the results obtained from the legally marketed predicate device, the BioRad Quantaphase II Folate Radioassay, on the same patient samples. This is a common approach for demonstrating substantial equivalence for new IVD devices.

8. The Sample Size for the Training Set

N/A - This is a traditional IVD method comparison study, not a machine learning model development. Therefore, there isn't a "training set" in the sense of data used to train an algorithm. The study described is entirely a validation or test set where the new device's analytical performance is compared against an established method.

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

N/A - As there is no training set in the machine learning context, this question is not applicable.

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