Cleared Traditional

K153692 - Synermed Glucose Reagent

K153692 is an FDA 510(k) clearance for Synermed Glucose Reagent, manufactured by Infrared Laboratory Systems, LLC (Dba Synermed). The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K153692 · Infrared Laboratory Systems, LLC (Dba Synermed) · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
184d
Days
Class 2
Risk

K153692 is an FDA 510(k) clearance for the Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Infrared Laboratory Systems, LLC (Dba Synermed) (Westfield, US). The FDA issued a Cleared decision on June 24, 2016 after a review of 184 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 Infrared Laboratory Systems, LLC (Dba Synermed) devices

FDA 510(k) Submission Details - K153692

510(k) Number K153692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2015
Decision Date June 24, 2016
Days to Decision 184 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
96d slower than avg
Panel avg: 88d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 258
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K153692.
i-Stat Alinity System with i-Stat Glucose test
K163271 · Abbott Point of Care, Inc. · Apr 2017
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
K160402 · Instrumentation Laboratory CO · Dec 2016
GEM Premier 3000
K161818 · Instrumentation Laboratory CO · Sep 2016
GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System
K142689 · Apex BioTechnology Corp. · Aug 2015
CardioChek Plus Test System
K151530 · Polymer Technology Systems, Inc. · Jul 2015
MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System
K143750 · Apex BioTechnology Corp. · May 2015