# DEN240032: APO-Easy Genotyping kit

- Pathway: De Novo (Direct)
- Applicant: Firalis SA
- Decided: Jun 12, 2025 after 356 days
- Product code: SFC (Neurologic Disease Risk Assessment Molecular Test)
- Device class: 2
- Regulation: 21 CFR 866.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
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 APO-Easy Genotyping kit is not a screening or diagnostic test and does not determine the person's overall risk of developing late-onset AD. It is not intended to replace any clinical and diagnostic examinations.

Source page: https://510kreport.com/device/DEN240032
Methodology: https://510kreport.com/methodology