Cleared Traditional

K932386 - VENTANA RED DETECTION KIT

K932386 is the FDA 510(k) clearance for VENTANA RED DETECTION KIT by Ventana Medical Systems, Inc.. It is a Class 2 Immunology device (product code DEY) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K932386 · Ventana Medical Systems, Inc. · Immunology device
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Aug 1993
Decision
84d
Days
Class 2
Risk

K932386 is an FDA 510(k) clearance for the VENTANA RED DETECTION KIT. Classified as Igm, Peroxidase, Antigen, Antiserum, Control (product code DEY), Class II - Special Controls.

Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on August 9, 1993 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ventana Medical Systems, Inc. devices

Submission Details

510(k) Number K932386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1993
Decision Date August 09, 1993
Days to Decision 84 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
20d faster than avg
Panel avg: 104d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEY Igm, Peroxidase, 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.