Cleared Traditional

K003196 - SYNCHRON SYSTEMS AMMONIA REAGENT

K003196 is an FDA 510(k) clearance for SYNCHRON SYSTEMS AMMONIA REAGENT, manufactured by Beckman Coulter, Inc.. The device is a Class 1 Chemistry device with product code JIF cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K003196 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
71d
Days
Class 1
Risk

K003196 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS AMMONIA REAGENT. Classified as Enzymatic Method, Ammonia (product code JIF), Class I - General Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on December 22, 2000 after a review of 71 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 Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K003196

510(k) Number K003196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2000
Decision Date December 22, 2000
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

JIF Device Classification - Class 1, General Controls

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 28
Devices cleared under the same product code (JIF) and FDA review panel - the closest regulatory comparables to K003196.
RANDOX AMMONIA
K030873 · Randox Laboratories, Ltd. · May 2003
AMMONIA ASSAY FOR THE ADVIA 1650
K023841 · Bayer Diagnostics Corp. · Dec 2002
AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K021151 · Bayer Diagnostics Corp. · Jul 2002
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30
K001285 · Diagnostic Chemicals , Ltd. · Jun 2000
SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT
K984402 · Beckman Coulter, Inc. · Jan 1999
AMM
K981920 · Abbott Laboratories · Jul 1998