Cleared Traditional

K242706 - Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242706 · Fujirebio Diagnostics,Inc. · Immunology device
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May 2025
Decision
249d
Days
Class 2
Risk

K242706 is an FDA 510(k) clearance for the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. Classified as Immunoassay Blood Test For Amyloid Pathology Assessment (product code SET), Class II - Special Controls.

Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on May 16, 2025 after a review of 249 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5840 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujirebio Diagnostics,Inc. devices

Submission Details

510(k) Number K242706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2024
Decision Date May 16, 2025
Days to Decision 249 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 104d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SET Immunoassay Blood Test For Amyloid Pathology Assessment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5840
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.