Cleared Traditional

ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,

K093957 · Fujirebio Diagnostics,Inc. · Immunology
Mar 2010
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K093957 is an FDA 510(k) clearance for the ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,, 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 March 18, 2010, 85 days after receiving the submission on December 23, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K093957 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2009
Decision Date March 18, 2010
Days to Decision 85 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.