Cleared Traditional

K172471 - VENTANA CD30 (Ber-H2) RxDx Assay

K172471 is an FDA 510(k) clearance for VENTANA CD30 (Ber-H2) RxDx Assay, manufactured by Ventana Medical Systems, Inc.. The device is a Class 2 Medical Genetics device with product code DEH cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K172471 · Ventana Medical Systems, Inc. · Medical Genetics device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
266d
Days
Class 2
Risk

K172471 is an FDA 510(k) clearance for the VENTANA CD30 (Ber-H2) RxDx Assay. Classified as Lambda, Antigen, Antiserum, Control (product code DEH), Class II - Special Controls.

Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on May 8, 2018 after a review of 266 days - an extended review cycle.

This device falls under the Medical Genetics FDA review panel, regulated under 21 CFR 866.5550 - the FDA medical genetics 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Medical Genetics review framework, consistent with the majority of Class II 510(k) submissions.

View all Ventana Medical Systems, Inc. devices

FDA 510(k) Submission Details - K172471

510(k) Number K172471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2017
Decision Date May 08, 2018
Days to Decision 266 days
Submission Type Traditional
Review Panel Medical Genetics (MG)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 397d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEH Device Classification - Class 2, Special Controls

Product Code DEH Lambda, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 Medical Genetics devices follow this clearance model.

Regulatory Peers - DEH Lambda, Antigen, Antiserum, Control

All 46
Devices cleared under the same product code (DEH) and FDA review panel - the closest regulatory comparables to K172471.
FREELITE HUMAN LAMBDA FREE KIT
K140396 · The Binding Site Group , Ltd. · Apr 2014
LAMBDA LIGHT CHAINS
K083601 · SENTINEL CH. SpA · Jun 2009
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER
K033811 · The Binding Site, Ltd. · Jan 2004
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II
K031016 · The Binding Site, Ltd. · Jul 2003
FREELITE HUMAN LAMBDA FREE KIT
K023131 · The Binding Site, Ltd. · Jan 2003
FREELITE LAMBDA FREE KIT
K010440 · The Binding Site, Ltd. · Apr 2001