Cleared Traditional

K183517 - Ammonia II

K183517 is the FDA 510(k) clearance for Ammonia II by Roche Diagnostics Operations (Rdo). It is a Class 1 Chemistry device (product code JIF) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K183517 · Roche Diagnostics Operations (Rdo) · Chemistry device
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Feb 2019
Decision
52d
Days
Class 1
Risk

K183517 is an FDA 510(k) clearance for the Ammonia II. Classified as Enzymatic Method, Ammonia (product code JIF), Class I - General Controls.

Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on February 8, 2019 after a review of 52 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 Roche Diagnostics Operations (Rdo) devices

Submission Details

510(k) Number K183517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2018
Decision Date February 08, 2019
Days to Decision 52 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
36d faster than avg
Panel avg: 88d · This submission: 52d
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 21
Devices cleared under the same product code (JIF) and FDA review panel - the closest regulatory comparables to K183517.
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