Cleared Traditional

K100187 - EASYRA GLU-T REAGENT

K100187 is the FDA 510(k) clearance for EASYRA GLU-T REAGENT by Medica Corp.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K100187 · Medica Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
103d
Days
Class 2
Risk

K100187 is an FDA 510(k) clearance for the EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on May 5, 2010 after a review of 103 days - within the typical 510(k) review window.

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 Medica Corp. devices

Submission Details

510(k) Number K100187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2010
Decision Date May 05, 2010
Days to Decision 103 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 88d · This submission: 103d
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.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 128
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K100187.
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
K103842 · Beckman Coulter, Inc. · Apr 2011
FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM
K100405 · Taidoc Technology Corporation · Jul 2010
FORA V20 BLOOD GLUCOSE MONITORING SYSTEM
K100406 · Taidoc Technology Corporation · May 2010
CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267
K093506 · Taidoc Technology Corporation · Apr 2010
CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265
K093941 · Taidoc Technology Corporation · Mar 2010
FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K091814 · Taidoc Technology Corporation · Nov 2009