Cleared Traditional

ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5

K112624 · Roche Diagnostics · Immunology

Sep 2012

Decision

368d

Days

Class 2

Risk

About This 510(k) Submission

K112624 is an FDA 510(k) clearance for the ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5, a Test, Epithelial Ovarian Tumor Associated Antigen (he4) (Class II — Special Controls, product code OIU), submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 10, 2012, 368 days after receiving the submission on September 8, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K112624 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 2011
Decision Date	September 10, 2012
Days to Decision	368 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.