510(k) K072939

HE4 EIA, MODEL: 404-10 US by Fujirebio Diagnostics,Inc. — Product Code OIU

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 9, 2008
Date Received: October 17, 2007
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Test, Epithelial Ovarian Tumor Associated Antigen (He4)
Device Class: Class II
Regulation Number: 866.6010
Review Panel: IM
Submission Type

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.

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Other clearances for product code OIU

K151378 — Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators (November 24, 2015)
K112624 — ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK (September 10, 2012)
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