510(k) Report

FDA product code · Immunology

Immunoassay Blood Test For Amyloid Pathology Assessment

SETClass II21 CFR 866.5840510(k) required4 decisions since 20250 recalls

4 FDA decisions since 2025. 510(k) reviews decided 2021–2025 took a median of 170 days (half between 130 and 209). No recall names this code. The most-cited predicate is K242706, named by 1 later device.

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 the test are to be interpreted in conjunction with other patient clinical information.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, immunology panel

Twenty years of SET at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · SET

2in 2025

2025: 22026 (partial year): 2
2007high 2 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SET

Too few SET 510(k)s in any year since 2007 to give a median.

Recalls per year · SET

No recall names SET since 2007.

Adverse event reports per year · SET

No MAUDE report names SET since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20252—00
20262—0—
FIG. 1 — SET by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in SET? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do SET devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc. · 20251cites it

Which SET devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K261686Elecsys Phospho-Tau (217P) PlasmaRoche Diagnostics · 20262generations
  • K252163Elecsys Phospho-Tau (181P) PlasmaRoche Diagnostics · 20252generations
  • K253240PrecivityAD2 TestC2N Diagnostics, LLC · 20261generation
  • K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc. · 20251generation

What has FDA decided in SET lately?

  • K261686Elecsys Phospho-Tau (217P) PlasmaRoche Diagnostics · 2026
  • K253240PrecivityAD2 TestC2N Diagnostics, LLC · 2026
  • K252163Elecsys Phospho-Tau (181P) PlasmaRoche Diagnostics · 2025
  • K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc. · 20257 recalls

All 4 SET decisions →

Related product codes

Other codes under 21 CFR 866.5840.

QSE Alzheimer’S Disease Pathology Assessment Test