OIU · Class II · 21 CFR 866.6010

FDA Product Code OIU: Test, Epithelial Ovarian Tumor Associated Antigen (he4)

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.

Leading manufacturers include Fujirebio Diagnostics,Inc. and Roche Diagnostics.

5
Total
5
Cleared
218d
Avg days
2008
Since

FDA 510(k) Cleared Test, Epithelial Ovarian Tumor Associated Antigen (he4) Devices (Product Code OIU)

5 devices
1–5 of 5
Cleared Nov 24, 2015
Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
K151378
Fujirebio Diagnostics,Inc.
Immunology · 186d
Cleared Sep 10, 2012
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
K112624
Roche Diagnostics
Immunology · 368d
Cleared Jul 19, 2011
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
K103676
Fujirebio Diagnostics,Inc.
Immunology · 215d
Cleared Mar 18, 2010
ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
K093957
Fujirebio Diagnostics,Inc.
Immunology · 85d
Cleared Jun 09, 2008
HE4 EIA, MODEL: 404-10 US
K072939
Fujirebio Diagnostics,Inc.
Immunology · 236d

About Product Code OIU - Regulatory Context