Cleared Traditional

K981653 - AMY

K981653 is an FDA 510(k) clearance for AMY, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code JFJ cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K981653 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
109d
Days
Class 2
Risk

K981653 is an FDA 510(k) clearance for the AMY. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on August 28, 1998 after a review of 109 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K981653

510(k) Number K981653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1998
Decision Date August 28, 1998
Days to Decision 109 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
21d slower than avg
Panel avg: 88d · This submission: 109d
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 82
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K981653.
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
K011145 · Roche Diagnostics Corp. · Jun 2001
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
K001569 · Sigma Diagnostics, Inc. · Jun 2000
WAKO L-TYPE AMYLASE
K984184 · Wako Chemicals USA, Inc. · Jan 1999
AMY
K981216 · Abbott Laboratories · Jun 1998
IL TEST AMYLASE
K974125 · Instrumentation Laboratory CO · Dec 1997
AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
K974053 · Diagnostic Chemicals , Ltd. · Dec 1997