Cleared Traditional

Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer (K153692) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153692 · Infrared Laboratory Systems, LLC (Dba Synermed) · Chemistry device
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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

Submission Details

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.

Device Classification

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.

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