Cleared Traditional

K051114 - SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY

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

K051114 · Sentinel Ch. Srl · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K051114

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 88d · This submission: 207d
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 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
AMMONIA ASSAY FOR THE ADVIA 1650
K023841 · Bayer Diagnostics Corp. · Dec 2002