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510(k) K253240

Device
PrecivityAD2 Test
Applicant
C2N Diagnostics, LLC
510(k) number
K253240
Product code
SET
Decision
Substantially Equivalent (SESE)
Decision date
2026-08-19
Date received
2025-09-29
Regulation
866.5840
Classification name
Immunoassay Blood Test For Amyloid Pathology Assessment
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Ilana Fogelman
Address
4340 Duncan Ave. St. Louis MO US 63110 63110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code SET#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261686Elecsys Phospho-Tau (217P) PlasmaRoche Diagnostics2026-08-19
K252163Elecsys Phospho-Tau (181P) PlasmaRoche Diagnostics2025-10-08
K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc.2025-05-16