Cleared Traditional

K113547 - GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL

K113547 is an FDA 510(k) clearance for GAL-1E BLOOD GLUCOSE MONITORING SYSTEM ..., manufactured by Apex BioTechnology Corp.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K113547 · Apex BioTechnology Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
118d
Days
Class 2
Risk

K113547 is an FDA 510(k) clearance for the GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1.... Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Apex BioTechnology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on March 28, 2012 after a review of 118 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 Apex BioTechnology Corp. devices

FDA 510(k) Submission Details - K113547

510(k) Number K113547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2011
Decision Date March 28, 2012
Days to Decision 118 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
30d slower than avg
Panel avg: 88d · This submission: 118d
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 300
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K113547.
CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
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ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
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K120448 · Apex BioTechnology Corp. · Apr 2012
GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
K113208 · Apex BioTechnology Corp. · Jan 2012
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM
K103278 · I-Sens, Inc. · Oct 2011
ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
K111371 · ACON Laboratories, Inc. · Oct 2011