Cleared Traditional

CYFRA 21-1 EIA MODEL 211-10

K100831 · Fujirebio Diagnostics,Inc. · Immunology
May 2011
Decision
428d
Days
Class 2
Risk

About This 510(k) Submission

K100831 is an FDA 510(k) clearance for the CYFRA 21-1 EIA MODEL 211-10, a Cytokeratin Fragments 21-1 Eia Kit (Class II — Special Controls, product code OVK), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on May 26, 2011, 428 days after receiving the submission on March 24, 2010. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K100831 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2010
Decision Date May 26, 2011
Days to Decision 428 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code OVK — Cytokeratin Fragments 21-1 Eia Kit
Device Class Class II — 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.