De Novo · Granted
GrantedAPO-Easy Genotyping kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Firalis SA · SFC Neurologic Disease Risk Assessment Molecular Test
Granted on Jun 12, 2025 as a new device type through De Novo after a 356-day review.
- Decided
- Jun 12, 2025
- Review
- 356 days
- Class
- Class II
- Product code
- SFC
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SFC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SFC devicesSFC Neurologic Disease Risk Assessment Molecular Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SFC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SFC
Too few SFC 510(k)s in any year since 2007 to give a median.
Recalls per year · SFC
No recall names SFC since 2007.
Adverse event reports per year · SFC
No MAUDE report names SFC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (125 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240032 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240032: APO-Easy Genotyping kit.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240032
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026