Cleared Traditional

K893751 - AMYLASE TEST (AML) ITEM NUMBER: 65404

K893751 is an FDA 510(k) clearance for AMYLASE TEST (AML) ITEM NUMBER: 65404, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K893751

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.

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 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