Cleared Traditional

K051114 - SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY

K051114 is the FDA 510(k) clearance for SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY by Sentinel Ch. Srl. It is a Class 1 Chemistry device (product code JIF) cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K051114 · Sentinel Ch. Srl · Chemistry device
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Nov 2005
Decision
207d
Days
Class 1
Risk

K051114 is an FDA 510(k) clearance for the SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY. Classified as Enzymatic Method, Ammonia (product code JIF), Class I - General Controls.

Submitted by Sentinel Ch. Srl (Milano, IT). The FDA issued a Cleared decision on November 25, 2005 after a review of 207 days - an extended review 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: 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 Sentinel Ch. Srl devices

Submission Details

510(k) Number K051114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2005
Decision Date November 25, 2005
Days to Decision 207 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
119d slower than avg
Panel avg: 88d · This submission: 207d
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 24
Devices cleared under the same product code (JIF) and FDA review panel - the closest regulatory comparables to K051114.
DIMENSION VISTA
K123677 · Siemens Healthcare Diagnostics · Mar 2013
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
K123320 · Siemens Healthcare Diagnostics · Feb 2013
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
K062316 · Dade Behring, Inc. · Sep 2006
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
K033921 · Diagnostic Chemicals , Ltd. · Mar 2004
RANDOX AMMONIA
K030873 · Randox Laboratories, Ltd. · May 2003
SYNCHRON SYSTEMS AMMONIA REAGENT
K003196 · Beckman Coulter, Inc. · Dec 2000