Cleared Traditional

K973393 - CHEMMATE LCA

K973393 is the FDA 510(k) clearance for CHEMMATE LCA by Ventana Medical Systems, Inc.. It is a Class 2 Immunology device (product code DEH) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K973393 · Ventana Medical Systems, Inc. · Immunology device
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Sep 1997
Decision
86d
Days
Class 2
Risk

K973393 is an FDA 510(k) clearance for the CHEMMATE LCA. 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 September 25, 1997 after a review of 86 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 K973393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1997
Decision Date September 25, 1997
Days to Decision 86 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
18d faster than avg
Panel avg: 104d · This submission: 86d
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.

Regulatory Peers - DEH Lambda, Antigen, Antiserum, Control

All 43
Devices cleared under the same product code (DEH) and FDA review panel - the closest regulatory comparables to K973393.
DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING
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MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751)
K965022 · Dako Corp. · Nov 1997
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K941514 · Ventana Medical Systems, Inc. · Apr 1997
VENTANA ANTI-MELANOMA PRIMARY ANTIBODY
K941170 · Ventana Medical Systems, Inc. · Apr 1997
ANTI-MUSCLE ACTIN PRIMARY ANTIBODY
K941707 · Ventana Medical Systems, Inc. · Apr 1997