Cleared Traditional

K102816 - GAL-1C BLOOD GLUCOSE MONITORING SYSTEM

K102816 is the FDA 510(k) clearance for GAL-1C BLOOD GLUCOSE MONITORING SYSTEM by Apex BioTechnology Corp.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K102816 · Apex BioTechnology Corp. · Chemistry device
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Sep 2011
Decision
352d
Days
Class 2
Risk

K102816 is an FDA 510(k) clearance for the GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Apex BioTechnology Corp. (Hsinchu, TW). The FDA issued a Cleared decision on September 15, 2011 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K102816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2010
Decision Date September 15, 2011
Days to Decision 352 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
264d slower than avg
Panel avg: 88d · This submission: 352d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBW System, Test, Blood Glucose, Over The Counter
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 - NBW System, Test, Blood Glucose, Over The Counter

All 235
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