Cleared Traditional

K893751 - AMYLASE TEST (AML) ITEM NUMBER: 65404

K893751 is the FDA 510(k) clearance for AMYLASE TEST (AML) ITEM NUMBER: 65404 by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K893751 · Em Diagnostic Systems, Inc. · Chemistry device
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Aug 1989
Decision
90d
Days
Class 2
Risk

K893751 is an FDA 510(k) clearance for the AMYLASE TEST (AML) ITEM NUMBER: 65404. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on August 17, 1989 after a review of 90 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K893751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1989
Decision Date August 17, 1989
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
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 72
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K893751.
DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI
K901017 · E.I. Dupont DE Nemours & Co., Inc. · May 1990
COULTER AMYLASE REAGENT
K900230 · Coulter Corp. · Apr 1990
AMYLASE REAGENT
K896650 · Sigma Chemical Co. · Feb 1990
ABBOTT SPECTRUM AMYLASE REAGENT
K891241 · Abbott Laboratories · Aug 1989
PANCREATIC A-AMYLASE PNP
K892848 · Boehringer Mannheim Corp. · Jul 1989
AMYLASE SR LIQUID STABLE REAGENT SET
K885176 · Medical Analysis Systems, Inc. · Feb 1989