Cleared Traditional

K931979 - VENTANA NEGATIVE CONTROL REAGENT

K931979 is an FDA 510(k) clearance for VENTANA NEGATIVE CONTROL REAGENT, manufactured by Ventana Medical Systems, Inc.. The device is a Class 2 Immunology device with product code DEM cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K931979 · Ventana Medical Systems, Inc. · Immunology device
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Mar 1994
Decision
342d
Days
Class 2
Risk

K931979 is an FDA 510(k) clearance for the VENTANA NEGATIVE CONTROL REAGENT. Classified as Alpha-1-antitrypsin, Antigen, Antiserum, Control (product code DEM), Class II - Special Controls.

Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on March 30, 1994 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5130 - 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 Ventana Medical Systems, Inc. devices

FDA 510(k) Submission Details - K931979

510(k) Number K931979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1993
Decision Date March 30, 1994
Days to Decision 342 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
237d slower than avg
Panel avg: 105d · This submission: 342d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEM Device Classification - Class 2, Special Controls

Product Code DEM Alpha-1-antitrypsin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5130
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 - DEM Alpha-1-antitrypsin, Antigen, Antiserum, Control

All 25
Devices cleared under the same product code (DEM) and FDA review panel - the closest regulatory comparables to K931979.
CHEMMATE LAMBDA
K973392 · Ventana Medical Systems, Inc. · Oct 1997
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IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
K964766 · Beckman Instruments, Inc. · Apr 1997
IL TEST ALPHA-1-ANTITRYPSIN (AAT)
K920005 · Instrumentation Laboratory CO · Jul 1992
ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT
K913666 · The Binding Site, Ltd. · Dec 1991
SPQ(TM) ANTIBODY REAGENT SET II FOR AAT
K890415 · Atlantic Antibodies · Feb 1989