Cleared Traditional

K093957 - ARCHITECT HE4

K093957 is the FDA 510(k) clearance for ARCHITECT HE4 by Fujirebio Diagnostics,Inc.. It is a Class 2 Immunology device (product code OIU) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K093957 · Fujirebio Diagnostics,Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
85d
Days
Class 2
Risk

K093957 is an FDA 510(k) clearance for the ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2.... Classified as Test, Epithelial Ovarian Tumor Associated Antigen (he4) (product code OIU), Class II - Special Controls.

Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on March 18, 2010 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fujirebio Diagnostics,Inc. devices

Submission Details

510(k) Number K093957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 104d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OIU Test, Epithelial Ovarian Tumor Associated Antigen (he4)
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - OIU Test, Epithelial Ovarian Tumor Associated Antigen (he4)

Devices cleared under the same product code (OIU) and FDA review panel - the closest regulatory comparables to K093957.
Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
K151378 · Fujirebio Diagnostics,Inc. · Nov 2015
ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
K112624 · Roche Diagnostics · Sep 2012
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
K103676 · Fujirebio Diagnostics,Inc. · Jul 2011
HE4 EIA, MODEL: 404-10 US
K072939 · Fujirebio Diagnostics,Inc. · Jun 2008