(142 days)
The Diazyme Folate Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of folate in human serum. Folic acid measurements are used in the diagnosis and treatment of anemias. For in-vitro diagnostic use only.
The Diazyme Folate Calibrator Set is intended for use in the calibration of the Diazyme Folate Assay. For in vitro diagnostic use only.
The Diazyme Folate Control Set is intended for use as quality controls for the Diazyme Folate Assay. For in vitro diagnostic use only.
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The provided text describes the FDA 510(k) clearance for the Diazyme Folate Assay, Diazyme Folate Calibrator Set, and Diazyme Folate Control Set. It focuses on the regulatory approval process and includes an "Indications for Use" statement.
Crucially, the document is a regulatory approval letter and not a study report. Therefore, it does not contain the detailed performance data, study design, or methodology information required to answer most of your questions about acceptance criteria verification and study details.
The information provided only allows for a very limited and generic answer:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied): The device must be "substantially equivalent" to legally marketed predicate devices for the stated indications for use.
- Reported Device Performance: The FDA determined that the device is "substantially equivalent" to legally marketed predicate devices.
2. Sample size used for the test set and the data provenance
NOT PROVIDED IN THE DOCUMENT. This document does not detail the specific performance studies that Diazyme Laboratories conducted to demonstrate substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
NOT PROVIDED IN THE DOCUMENT.
4. Adjudication method for the test set
NOT PROVIDED IN THE DOCUMENT.
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
NOT APPLICABLE. This is an in vitro diagnostic (IVD) assay for measuring folate levels, not an AI-assisted diagnostic imaging device. Therefore, MRMC studies and human reader improvement with AI are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
NOT APPLICABLE. As an IVD assay, its performance is inherently "standalone" in a laboratory setting, meaning it measures a biomarker without human interpretation of complex images or AI algorithms. However, the document does not contain the specific performance data (e.g., accuracy, precision, linearity) that would typically be generated in such a study.
7. The type of ground truth used
NOT PROVIDED IN THE DOCUMENT. For an IVD assay, ground truth would typically be established through reference methods, clinical diagnosis, or patient outcomes for the condition being diagnosed/monitored (anemia in this case).
8. The sample size for the training set
NOT PROVIDED IN THE DOCUMENT.
9. How the ground truth for the training set was established
NOT PROVIDED IN THE DOCUMENT.
In summary, the provided FDA 510(k) clearance letter confirms regulatory approval based on substantial equivalence but does not contain the detailed study data, methodologies, or acceptance criteria that would typically be found in a clinical study report or a 510(k) submission's performance section. To answer your questions comprehensively, you would need to review the actual 510(k) submission materials, which are not included in this document.
§ 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.