Cleared Traditional

AMY (K981216) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981216 · Abbott Laboratories · Chemistry device
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Optimized for regulatory review, auditing and printing
Jun 1998
Decision
66d
Days
Class 2
Risk

K981216 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 June 8, 1998 after a review of 66 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

Submission Details

510(k) Number K981216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1998
Decision Date June 08, 1998
Days to Decision 66 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
22d faster than avg
Panel avg: 88d · This submission: 66d
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 45
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K981216.
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
K981653 · Abbott Laboratories · Aug 1998
IL TEST AMYLASE
K974125 · Instrumentation Laboratory CO · Dec 1997
ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
K972250 · Roche Diagnostic Systems, Inc. · Aug 1997
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
K971825 · Randox Laboratories, Ltd. · Jul 1997