# K253240: PrecivityAD2 Test

- Pathway: 510(k) (Traditional)
- Applicant: C2N Diagnostics, LLC
- Decided: Aug 19, 2026 after 324 days
- Product code: SET (Immunoassay Blood Test For Amyloid Pathology Assessment)
- Device class: 2
- Regulation: 21 CFR 866.5840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN200072 (2022). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200072: Lumipulse G ß-Amyloid Ratio (1-42/1-40), Fujirebio Diagnostics,Inc. (2022) Summary page 10.

## Indications for use
The PrecivityAD2 test is an in vitro device that uses immunoprecipitation followed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) to quantify β-Amyloid 1-42 (Aβ42) and β-Amyloid 1-40 (Aβ40) peptide concentrations, and phosphorylated and non-phosphorylated tau protein at amino acid threonine, position 217 (p-tau217 and np-tau217) peptide concentrations in human K2-EDTA plasma. An algorithm combines the Aβ42/40 ratio and the p-tau217/np-tau217 ratio x 100 (%p-tau217) to generate the Amyloid Probability Score 2 (APS2) result, a numeric value ranging from 0-100. The PrecivityAD2 test is indicated for use in adults aged 40 years and older who present with signs or symptoms of cognitive impairment undergoing evaluation for Alzheimer’s disease or other forms of cognitive decline. The PrecivityAD2 test is intended to be used in conjunction with clinical assessment to aid health care professionals experienced in the evaluation of cognitive impairment to identify patients with amyloid pathology associated with Alzheimer’s disease. The test is not intended as a screening or stand-alone diagnostic test.

Source page: https://510kreport.com/device/K253240
Methodology: https://510kreport.com/methodology