Cleared Traditional

K963425 - GENZYME DIAGNOSTICS CONTRAST MONO

K963425 is an FDA 510(k) clearance for GENZYME DIAGNOSTICS CONTRAST MONO, manufactured by Genzyme Diagnostics. The device is a Class 2 Immunology device with product code KTN cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K963425 · Genzyme Diagnostics · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
179d
Days
Class 2
Risk

K963425 is an FDA 510(k) clearance for the GENZYME DIAGNOSTICS CONTRAST MONO. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by Genzyme Diagnostics (San Carlos, US). The FDA issued a Cleared decision on February 25, 1997 after a review of 179 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5640 - 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. Standard predicate reliance. 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 Genzyme Diagnostics devices

FDA 510(k) Submission Details - K963425

510(k) Number K963425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1996
Decision Date February 25, 1997
Days to Decision 179 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
74d slower than avg
Panel avg: 105d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTN Device Classification - Class 2, Special Controls

Product Code KTN System, Test, Infectious Mononucleosis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5640
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 - KTN System, Test, Infectious Mononucleosis

All 42
Devices cleared under the same product code (KTN) and FDA review panel - the closest regulatory comparables to K963425.
CLEARVIEW IM
K981946 · Unipath , Ltd. · Dec 1998
MONOCOL/LEX-IM TEST
K972457 · Immunostics Inc., · Dec 1997
OSOM MONO TEST 143
K972231 · Wyntek Diagnostics, Inc. · Aug 1997
BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
K961024 · Princeton BioMeditech Corp. · Feb 1997
QUALITROL MONO CONTROL SERUM SET
K961550 · Consolidated Technologies, Inc. · Sep 1996
IMMUNOCARD MONO
K930778 · Meridian Diagnostics, Inc. · Dec 1993