21 CFR 866.5850 — Neurologic Disease Risk Assessment Molecular Test
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5850
Identification
The APO-Easy Genotyping kit is a qualitative polymerase chain reaction (PCR) test intended for the detection of two single nucleotide polymorphisms (SNPs), rs429358 and rs7412, in the APOE gene using genomic DNA extracted from human EDTA whole blood. The APOE genotype information provided by the test is used with other laboratory and clinical information to aid in the evaluation of the risk of developing late-onset Alzheimer's Disease (AD) in patients presenting with cognitive impairment and/or with predisposing risk factors, who are being evaluated for AD and other causes of cognitive decline. The device is not a screening or diagnostic test and does not determine the person's overall risk of developing late-onset AD.
Classification Rationale
FDA has determined that, for the previously stated indications for use, the APO-Easy Genotyping kit can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| SFC | Neurologic Disease Risk Assessment Molecular Test | 2 | 1 |
Special Controls
SFC — Neurologic Disease Risk Assessment Molecular Test
(1) Design verification and validation must include: (i) Device performance data demonstrating appropriate analytical performance for the intended use specimen type(s), including precision and reproducibility, detection limit of the device, linearity, assay interference, cross-reactivity, specimen and reagent stability, and analytical accuracy studies, as determined to be appropriate by FDA. For devices that are intended to measure multiple genetic or protein variants, the performance data must demonstrate the analytical performance of the device for each individual variant and for any output(s) that combine multiple variants. (ii) Clinical performance data or evidence to support the intended use of the device. The neurological disease risk assessment must be representative of the intended use population and include well-established scientific literature, clinical performance data, or both, as determined to be appropriate by FDA. (2) The labeling must include: (i) Limiting statements that the test is not a screening or diagnostic test and that the test does not determine the patient's overall risk of developing the specified neurologic disease. (ii) An appropriate summary, as determined by FDA, of the performance data or evidence that relate to all design verification and validation special controls, as well as a description of the detection targets.
De Novo Order DEN240032
