Cleared Traditional

K172471 - VENTANA CD30 (Ber-H2) RxDx Assay (FDA 510(k) Clearance)

Class II Medical Genetics device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172471 · Ventana Medical Systems, Inc. · Medical Genetics device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 399d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.