Cleared Traditional

AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K021151) - FDA 510(k) Clearance

Class I Chemistry device.

K021151 · Bayer Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
94d
Days
Class 1
Risk

K021151 is an FDA 510(k) clearance for the AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM. Classified as Enzymatic Method, Ammonia (product code JIF), Class I - General Controls.

Submitted by Bayer Diagnostics Corp. (Tarrytown, US). The FDA issued a Cleared decision on July 13, 2002 after a review of 94 days - within the typical 510(k) review window.

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: 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 Bayer Diagnostics Corp. devices

Submission Details

510(k) Number K021151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2002
Decision Date July 13, 2002
Days to Decision 94 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 88d · This submission: 94d
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 29
Devices cleared under the same product code (JIF) and FDA review panel - the closest regulatory comparables to K021151.
Ammonia II
K183517 · Roche Diagnostics Operations (Rdo) · Feb 2019
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
K062316 · Dade Behring, Inc. · Sep 2006
SYNCHRON SYSTEMS AMMONIA REAGENT
K003196 · Beckman Coulter, Inc. · Dec 2000
SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT
K984402 · Beckman Coulter, Inc. · Jan 1999
AMM
K981920 · Abbott Laboratories · Jul 1998
AMM
K981467 · Abbott Laboratories · Jun 1998