Cleared Special

K142689 - GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System

K142689 is an FDA 510(k) clearance for GAL-1F Blood Glucose Monitoring System, manufactured by Apex BioTechnology Corp.. The device is a Class 2 Chemistry device with product code CGA cleared through the Special 510(k) pathway after a 318-day FDA review.

K142689 · Apex BioTechnology Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
318d
Days
Class 2
Risk

K142689 is an FDA 510(k) clearance for the GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring S.... 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 August 6, 2015 after a review of 318 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K142689

510(k) Number K142689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2014
Decision Date August 06, 2015
Days to Decision 318 days
Submission Type Special
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
229d slower than avg
Panel avg: 89d · This submission: 318d
Pathway characteristics
Modification to existing cleared device.

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

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K142689 · GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System
Download PDF FDA Summary Apex BioTechnology Co…