510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253240Substantially Equivalent

PrecivityAD2 Test

C2N Diagnostics, LLC, St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253240 is the FDA 510(k) clearance record for PrecivityAD2 Test, a class II device, cleared for C2N Diagnostics, LLC on under FDA product code SET (Immunoassay Blood Test For Amyloid Pathology Assessment). FDA's definition for product code SET reads: "An Immunoassay blood test for amyloid pathology assessment is an in vitro diagnostic test used to identify patients with amyloid pathology associated with Alzheimer’s Disease who have signs and symptoms of cognitive decline. The results of...". As of , FDA records show no recalls naming K253240.

Clearance record

Decision date
Received
(324 days to decision)
Product code
SET Immunoassay Blood Test For Amyloid Pathology Assessment
Regulation
21 CFR 866.5840
Device class
Class II
Review panel
Immunology
Applicant
C2N Diagnostics, LLC 4340 Duncan Ave., St. Louis MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SET

Trailing 12 months
2 clearances under product code SET in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code SET, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20262
September 20260
October 20260