Cleared Traditional

K965022 - MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751)

K965022 is an FDA 510(k) clearance for MONOCLONAL MOUSE ANTI-HUMAN CD30, manufactured by Dako Corp.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K965022

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
220d slower than avg
Panel avg: 105d · This submission: 325d
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 Immunology devices follow this clearance model.

Regulatory Peers - DEH Lambda, Antigen, Antiserum, Control

All 45
Devices cleared under the same product code (DEH) and FDA review panel - the closest regulatory comparables to K965022.
LAMBDA IMMAGE FREELITE KIT
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DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING
K971905 · Dako Corp. · Dec 1997
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K940583 · Ventana Medical Systems, Inc. · Oct 1997
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K941514 · Ventana Medical Systems, Inc. · Apr 1997