Cleared Traditional

K942640 - DUPONT DIMENSION AMYLASE METHOD

K942640 is an FDA 510(k) clearance for DUPONT DIMENSION AMYLASE METHOD, manufactured by Dupont Medical Products. The device is a Class 2 Chemistry device with product code JFJ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K942640 · Dupont Medical Products · Chemistry device
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Sep 1994
Decision
98d
Days
Class 2
Risk

K942640 is an FDA 510(k) clearance for the DUPONT DIMENSION AMYLASE METHOD. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Dupont Medical Products (Wilmington, US). The FDA issued a Cleared decision on September 9, 1994 after a review of 98 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 Dupont Medical Products devices

FDA 510(k) Submission Details - K942640

510(k) Number K942640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1994
Decision Date September 09, 1994
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 88d · This submission: 98d
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 79
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K942640.
CATALOGUE NUMBER 321-07/15/50
K945243 · Diagnostic Chemicals , Ltd. · Feb 1995
AMYLASE QVET
K942961 · Prisma Systems · Dec 1994
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
GENZYME A-AMYLASE TEST REAGENT
K933397 · Genzyme Corp. · Oct 1993