Cleared Traditional

K250925 - ADVIA Centaur Cytokeratin Fragment 21-1 (FDA 510(k) Clearance)

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

K250925 · Fujirebio Diagnostics,Inc. · Immunology device
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Dec 2025
Decision
264d
Days
Class 2
Risk

K250925 is an FDA 510(k) clearance for the ADVIA Centaur Cytokeratin Fragment 21-1. Classified as Cytokeratin Fragments 21-1 Eia Kit (product code OVK), Class II - Special Controls.

Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on December 16, 2025 after a review of 264 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - 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 K250925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2025
Decision Date December 16, 2025
Days to Decision 264 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
160d slower than avg
Panel avg: 104d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVK Cytokeratin Fragments 21-1 Eia Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
Definition The Cyfra 21-1 Eia Kit Is Intended For The Quantitative Determination Of Soluble Cytokeratin 19 Fragments In Human Serum. The Assay Is To Be Used As An Aid In Monitoring Disease Progression During The Course Of Disease And Treatment In Lung Cancer Patients. Serial Testing For Patient Cyfra 21-1 Assay Values Should Be Used In Conjunction With Other Clinical Methods Used For Monitoring Lung Cancer.
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.