(178 days)
The ARCHITECT Folate assay is a chemiluminescent microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum and plasma on the ARCHITECT i System. Folate measurements are used in the diagnosis and treatment of megaloblastic anemia.
The ARCHITECT Folate Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of folate in human serum and plasma.
The ARCHITECT Folate Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of folate in human serum and plasma.
The ARCHITECT Folate assay is a two-step assay for the quantitative determination of folate in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology. Two pre-treatment steps mediate the release of folate from endogenous folate binding protein.
In Pre-Treatment Step 1, the sample and Pre-treatment Reagent 2 (Dithiothreitol or DTT) are aspirated and dispensed into a reaction vessel (RV). In Pre-Treatment Step 2, an aliquot of sample/Pre-Treatment Reagent 2 mixture is aspirated and dispensed into a second RV. Pre-Treatment Reagent 1 (potassium hydroxide or KOH) is then added. An aliquot of the pre-treated sample is transferred into a third RV, followed by the addition of Folate Binding Protein (FBP) coated paramagnetic microparticles and assay specific diluent. Folate present in the sample binds to the FBP coated microparticles. After washing, pteroic acid-acridinium labeled conjugate is added and binds to unoccupied sites on the FBP coated microparticles. Pre-Trigger and Trigger Solutions are then added to the reaction mixture; the resulting chemiluminescent reaction is measured as relative light units (RLUs). An inverse relationship exists between the amount of folate in the sample and the RLUs detected by the ARCHITECT i optical system.
The provided text describes a 510(k) submission for the ARCHITECT Folate assay, a medical device for quantitatively determining folate in human serum and plasma. The study conducted is a non-clinical performance comparison between the new ARCHITECT Folate assay and its predicate device, the AxSYM Folate assay.
Here's an analysis of the acceptance criteria and study as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | Substantially equivalent to predicate | Demonstrated substantially equivalent performance |
| Linearity | Substantially equivalent to predicate | Demonstrated substantially equivalent performance |
| Interferences | Substantially equivalent to predicate | Demonstrated substantially equivalent performance |
| Method Comparison | Good correlation with predicate | Correlation coefficient of 0.898 for serum samples |
| Bias | Understandable and attributable to standardization differences | General bias due to standardization differences (predicate uses gravimetric preparations, investigational assay standardized to WHO Serum Folate International Standard (IS) 03/178) |
Note: The document states "The ARCHITECT Folate assay demonstrated substantially equivalent performance to the AxSYM Folate assay with correlation coefficients of 0.898 for serum samples." The acceptance criteria for "substantially equivalent" in areas like precision, linearity, and interferences are not explicitly quantified with numerical thresholds in the provided text. They are implied by the claim of substantial equivalence to the predicate device.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size used for the test set in the comparison study.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is a non-clinical performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of study. The ground truth for a quantitative diagnostic assay is typically established through a reference method or standardization to an internationally recognized standard. In this case, the investigational assay was standardized to the WHO Serum Folate International Standard (IS) 03/178. Human expert consensus is not the method for establishing ground truth for quantitative laboratory tests like this.
4. Adjudication Method for the Test Set
This information is not applicable to this type of study. Adjudication methods (like 2+1 or 3+1) are typically used in studies where human readers are interpreting images or making subjective diagnoses, which is not the case for a quantitative immunoassay comparison. The comparison is likely done statistically between measured values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a non-clinical performance evaluation of a quantitative diagnostic assay, not an AI-assisted human reading study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, this was a standalone performance study of the ARCHITECT Folate assay. The document describes the assay's mechanism and then presents its performance characteristics (precision, linearity, interferences, method comparison) against a predicate device. There is no mention of human-in-the-loop performance testing.
7. The Type of Ground Truth Used
The ground truth for the investigational assay was established by standardization to the WHO Serum Folate International Standard (IS) 03/178. For the comparison with the predicate, the predicate device's results serve as a comparative "truth," which were themselves based on gravimetric preparations of folic acid.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning. This is a traditional immunoassay device, not an AI/ML-based device. Therefore, a training set as understood in AI/ML is not applicable. The assay is "standardized" rather than "trained."
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" in the machine learning sense for this device. The assay was standardized to accurately recover WHO Serum Folate International Standard (IS) 03/178. This standardization process involves calibrating the assay's response to known concentrations of the analyte based on this international standard.
§ 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.