Cleared Traditional

AMM (K981920) - FDA 510(k) Clearance

Class I Chemistry device.

K981920 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
51d
Days
Class 1
Risk

K981920 is an FDA 510(k) clearance for the AMM. Classified as Enzymatic Method, Ammonia (product code JIF), Class I - General Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on July 22, 1998 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1065 - 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 K981920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1998
Decision Date July 22, 1998
Days to Decision 51 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
37d faster than avg
Panel avg: 88d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIF Enzymatic Method, Ammonia
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1065
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JIF Enzymatic Method, Ammonia

All 16
Devices cleared under the same product code (JIF) and FDA review panel - the closest regulatory comparables to K981920.
RANDOX AMMONIA
K030873 · Randox Laboratories, Ltd. · May 2003
SYNCHRON SYSTEMS AMMONIA REAGENT
K003196 · Beckman Coulter, Inc. · Dec 2000
SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT
K984402 · Beckman Coulter, Inc. · Jan 1999
AMM
K981467 · Abbott Laboratories · Jun 1998
BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR
K934925 · Beckman Instruments, Inc. · Apr 1994
ROCHE REAGENT FOR AMMONIA
K913124 · Roche Diagnostic Systems, Inc. · Aug 1991