Cleared Traditional

K973391 - CHEMMATE KAPPA

K973391 is the FDA 510(k) clearance for CHEMMATE KAPPA by Ventana Medical Systems, Inc.. It is a Class 2 Immunology device (product code DEM) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K973391 · Ventana Medical Systems, Inc. · Immunology device
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Oct 1997
Decision
85d
Days
Class 2
Risk

K973391 is an FDA 510(k) clearance for the CHEMMATE KAPPA. 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 October 3, 1997 after a review of 85 days - a notably fast clearance cycle.

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: 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 K973391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1997
Decision Date October 03, 1997
Days to Decision 85 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
19d faster than avg
Panel avg: 104d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (DEM) and FDA review panel - the closest regulatory comparables to K973391.
TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY
K972640 · Boehringer Mannheim Corp. · Jan 1998
CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING
K973389 · Ventana Medical Systems, Inc. · Oct 1997
CHEMMATE L26 (CD20)
K973390 · Ventana Medical Systems, Inc. · Oct 1997
CHEMMATE LAMBDA
K973392 · Ventana Medical Systems, Inc. · Oct 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
K964766 · Beckman Instruments, Inc. · Apr 1997
VENTANA NEGATIVE CONTROL REAGENT
K931979 · Ventana Medical Systems, Inc. · Mar 1994