Cleared Traditional

K873944 - A-GENT LIQUID AMYLASE

K873944 is an FDA 510(k) clearance for A-GENT LIQUID AMYLASE, 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 56-day FDA review.

K873944 · Abbott Laboratories · Chemistry device
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Nov 1987
Decision
56d
Days
Class 2
Risk

K873944 is an FDA 510(k) clearance for the A-GENT LIQUID AMYLASE. 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 November 23, 1987 after a review of 56 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K873944

510(k) Number K873944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1987
Decision Date November 23, 1987
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
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 K873944.
AMYLASE SR LIQUID STABLE REAGENT SET
K885176 · Medical Analysis Systems, Inc. · Feb 1989
AMYLASE 405 CATALOG NUMBER 301-34
K880867 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1988
REFLOTRON (R) AMYLASE
K874704 · Boehringer Mannheim Corp. · Jan 1988
BNP-AMYLASE TEST
K873133 · Sclavo, Inc. · Oct 1987
AMYLASE TEST KIT
K872023 · Ciba Corning Diagnostics Corp. · Aug 1987
STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715
K870746 · Stanbio Laboratory · Jun 1987