510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231348Substantially Equivalent

Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF

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

K231348 is the FDA 510(k) clearance record for Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF, a class II device, cleared for Roche Diagnostics on under FDA product code QSE (Alzheimer’S Disease Pathology Assessment Test). FDA's definition for product code QSE reads: "In vitro test to determine whether a patient presenting with cognitive impairment and being evaluated for AD and other causes of cognitive decline will test positive or negative for amyloid plaques or neurofibrillary tangles as measured by...". FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show no recalls naming K231348.

Clearance record

Decision date
Received
(27 days to decision)
Product code
QSE Alzheimer’S Disease Pathology Assessment Test
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 QSE

Trailing 12 months

FDA records hold no clearances under product code QSE in the trailing twelve months.

FDA records show no clearances under product code QSE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QSE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260