Cleared Traditional

K021151 - AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

K021151 is an FDA 510(k) clearance for AMMONIA ASSAY FOR THE ADVIA INTEGRATED ..., manufactured by Bayer Diagnostics Corp.. The device is a Class 1 Chemistry device with product code JIF cleared through the Traditional 510(k) pathway after a 94-day FDA review.

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

FDA 510(k) Submission Details - K021151

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 88d · This submission: 94d
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 27
Devices cleared under the same product code (JIF) and FDA review panel - the closest regulatory comparables to K021151.
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
K033921 · Diagnostic Chemicals , Ltd. · Mar 2004
RANDOX AMMONIA
K030873 · Randox Laboratories, Ltd. · May 2003
AMMONIA ASSAY FOR THE ADVIA 1650
K023841 · Bayer Diagnostics Corp. · Dec 2002
SYNCHRON SYSTEMS AMMONIA REAGENT
K003196 · Beckman Coulter, Inc. · Dec 2000
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