Cleared Traditional

Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators

K151378 · Fujirebio Diagnostics,Inc. · Immunology

Nov 2015

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K151378 is an FDA 510(k) clearance for the Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators, 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 November 24, 2015, 186 days after receiving the submission on May 22, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K151378 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 2015
Decision Date	November 24, 2015
Days to Decision	186 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.