Cleared Traditional

K131750 - AUTOSURE HT BLOOD GLUCOSE MONITORING SY...

K131750 is the FDA 510(k) clearance for AUTOSURE HT BLOOD GLUCOSE MONITORING SY... by Apex BioTechnology Corp.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K131750 · Apex BioTechnology Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
265d
Days
Class 2
Risk

K131750 is an FDA 510(k) clearance for the AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM. 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 6, 2014 after a review of 265 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 Apex BioTechnology Corp. devices

Submission Details

510(k) Number K131750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2013
Decision Date March 06, 2014
Days to Decision 265 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
177d slower than avg
Panel avg: 88d · This submission: 265d
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 190
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