Cleared Traditional

K933397 - GENZYME A-AMYLASE TEST REAGENT

K933397 is an FDA 510(k) clearance for GENZYME A-AMYLASE TEST REAGENT, manufactured by Genzyme Corp.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K933397

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.

JFJ Device Classification - Class 2, Special Controls

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 93
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K933397.
SYNERMED AMYLASE REAGENT KIT
K941091 · Synermed, Inc. · May 1994
INTERSECT SYSTEMS DIRECT AMYLASE REAGENT
K932888 · Intersect Systems, Inc. · Jan 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