(68 days)
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.
| Sample | Regression Method | n | Acceptance Criteria (Implicit) | Reported Device Performance (r) | Reported Device Performance (Slope) | Reported Device Performance (Intercept) |
|---|---|---|---|---|---|---|
| Serum | Least Squares | 241 | Strong correlation; Slope ~ 1; Intercept ~ 0 | 0.904 | 0.93 | 1.4 |
| Passing-Bablok | 241 | Strong correlation; Slope ~ 1; Intercept ~ 0 | 0.904 | 1.05 | -0.0 | |
| Whole Blood | Least Squares | 244 | Strong correlation; Slope ~ 1; Intercept ~ 0 | 0.904 | 1.05 | -54.7 |
| Passing-Bablok | 244 | Strong correlation; Slope ~ 1; Intercept ~ 0 | 0.904 | 1.10 | -69.9 |
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.
§ 862.1295 Folic acid test system.
(a)
Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.(b)
Classification. Class II.