Cleared Traditional

VENTANA ANTI-CD8 PRIMARY ANTIBODY (K941784) - FDA 510(k) Clearance

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

K941784 · Ventana Medical Systems, Inc. · Immunology device
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Feb 1997
Decision
1040d
Days
Class 2
Risk

K941784 is an FDA 510(k) clearance for the VENTANA ANTI-CD8 PRIMARY ANTIBODY. 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 February 14, 1997 after a review of 1040 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Ventana Medical Systems, Inc. devices

Submission Details

510(k) Number K941784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1994
Decision Date February 14, 1997
Days to Decision 1040 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
936d slower than avg
Panel avg: 104d · This submission: 1040d
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.