Cleared Traditional

K965022 - MONOCLONAL MOUSE ANTI-HUMAN CD30

K965022 is the FDA 510(k) clearance for MONOCLONAL MOUSE ANTI-HUMAN CD30 by Dako Corp.. It is a Class 2 Immunology device (product code DEH) cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K965022 · Dako Corp. · Immunology device
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Nov 1997
Decision
325d
Days
Class 2
Risk

K965022 is an FDA 510(k) clearance for the MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZ.... Classified as Lambda, Antigen, Antiserum, Control (product code DEH), Class II - Special Controls.

Submitted by Dako Corp. (Carpinteria, US). The FDA issued a Cleared decision on November 6, 1997 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 Dako Corp. devices

Submission Details

510(k) Number K965022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1996
Decision Date November 06, 1997
Days to Decision 325 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
221d slower than avg
Panel avg: 104d · This submission: 325d
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 Immunology devices follow this clearance model.

Regulatory Peers - DEH Lambda, Antigen, Antiserum, Control

All 43
Devices cleared under the same product code (DEH) and FDA review panel - the closest regulatory comparables to K965022.
LAMBDA IMMAGE FREELITE KIT
K003671 · The Binding Site, Ltd. · Feb 2001
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K002563 · The Binding Site, Ltd. · Oct 2000
DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING
K971905 · Dako Corp. · Dec 1997
VENTANA CD45 PRIMARY ANTIBODY
K940583 · Ventana Medical Systems, Inc. · Oct 1997
CHEMMATE LCA
K973393 · Ventana Medical Systems, Inc. · Sep 1997
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K941514 · Ventana Medical Systems, Inc. · Apr 1997