Cleared Traditional

K933397 - GENZYME A-AMYLASE TEST REAGENT

K933397 is the FDA 510(k) clearance for GENZYME A-AMYLASE TEST REAGENT by Genzyme Corp.. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K933397 · Genzyme Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Oct 1993
Decision
108d
Days
Class 2
Risk

K933397 is an FDA 510(k) clearance for the GENZYME A-AMYLASE TEST REAGENT. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Genzyme Corp. (Cambridge, US). The FDA issued a Cleared decision on October 28, 1993 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1070 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Genzyme Corp. devices

Submission Details

510(k) Number K933397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1993
Decision Date October 28, 1993
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFJ Catalytic Methods, Amylase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1070
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 Chemistry devices follow this clearance model.

Regulatory Peers - JFJ Catalytic Methods, Amylase

All 73
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K933397.
OLYMPUS AMYLASE REAGENT
K944229 · Olympus America, Inc. · Dec 1994
SYNERMED AMYLASE REAGENT KIT
K941091 · Synermed, Inc. · May 1994
AMYLASE REAGENT SET (KINETIC)
K931080 · Teco Diagnostics · Nov 1993
ETHYLIDENE AMYL
K931582 · Em Diagnostic Systems, Inc. · Aug 1993
SILYL AMYL
K931583 · Em Diagnostic Systems, Inc. · Aug 1993
LIQUID AMYLASE REAGENT SET
K930475 · Pointe Scientific, Inc., · Jul 1993