510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252163Substantially Equivalent

Elecsys Phospho-Tau (181P) Plasma

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252163 is the FDA 510(k) clearance record for Elecsys Phospho-Tau (181P) Plasma, a class II device, cleared for Roche Diagnostics 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...". FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show no recalls naming K252163.

Clearance record

Decision date
Received
(90 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
Roche Diagnostics 9115 Hague Rd., Indianapolis IN
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