Cleared Traditional

FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL

K103676 · Fujirebio Diagnostics,Inc. · Immunology

Jul 2011

Decision

215d

Days

Class 2

Risk

About This 510(k) Submission

K103676 is an FDA 510(k) clearance for the FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL, a Test, Epithelial Ovarian Tumor Associated Antigen (he4) (Class II — Special Controls, product code OIU), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on July 19, 2011, 215 days after receiving the submission on December 16, 2010. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K103676 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 2010
Decision Date	July 19, 2011
Days to Decision	215 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	OIU — Test, Epithelial Ovarian Tumor Associated Antigen (he4)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.6010
Definition	An Enzyme Immunometric Assay For The Quantitative Determination Of He4 In Human Serum. The Assay Is To Be Used As An Aid In Monitoring Recurrence Or Progressive Disease In Patients With Epithelial Ovarian Cancer. Serial Testing For Patient He4 Assay Values Should Be Used In Conjunction With Other Clinical Methods Used For Monitoring Ovarian Cancer. It Is Not Intended To Estimate Or Assess The Risk Of Disease Outcomes Of Patients.