Cleared Special

K150274 - GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System

K150274 is an FDA 510(k) clearance for GDH Professional Blood Glucose Monitori..., manufactured by Infopia Co, Ltd.. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 203-day FDA review.

K150274 · Infopia Co, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
203d
Days
Class 2
Risk

K150274 is an FDA 510(k) clearance for the GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blo.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Infopia Co, Ltd. (Anyang, KR). The FDA issued a Cleared decision on August 26, 2015 after a review of 203 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Infopia Co, Ltd. devices

FDA 510(k) Submission Details - K150274

510(k) Number K150274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2015
Decision Date August 26, 2015
Days to Decision 203 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
115d slower than avg
Panel avg: 88d · This submission: 203d
Pathway characteristics
Modification to existing cleared device.

NBW Device Classification - Class 2, Special Controls

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 Consultant

LK Consulting Group USA, Inc.
PRISCILLA CHUNG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 420
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