Cleared Traditional

K112624 - ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5

K112624 is an FDA 510(k) clearance for ELECSYS HE4, manufactured by Roche Diagnostics. The device is a Class 2 Immunology device with product code OIU cleared through the Traditional 510(k) pathway after a 368-day FDA review.

K112624 · Roche Diagnostics · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
368d
Days
Class 2
Risk

K112624 is an FDA 510(k) clearance for the ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHE.... Classified as Test, Epithelial Ovarian Tumor Associated Antigen (he4) (product code OIU), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 10, 2012 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostics devices

FDA 510(k) Submission Details - K112624

510(k) Number K112624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
263d slower than avg
Panel avg: 105d · This submission: 368d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OIU Device Classification - Class 2, Special Controls

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 K112624.
Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
K151378 · Fujirebio Diagnostics,Inc. · Nov 2015
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
K103676 · Fujirebio Diagnostics,Inc. · Jul 2011
ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
K093957 · Fujirebio Diagnostics,Inc. · Mar 2010
HE4 EIA, MODEL: 404-10 US
K072939 · Fujirebio Diagnostics,Inc. · Jun 2008