Cleared Traditional

K130244 - DIATRUE PLUS BLOOD GLUCOSE MONITORING S...

K130244 is an FDA 510(k) clearance for DIATRUE PLUS BLOOD GLUCOSE MONITORING S..., manufactured by Delbio Incorporation. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K130244 · Delbio Incorporation · Chemistry device
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Aug 2013
Decision
204d
Days
Class 2
Risk

K130244 is an FDA 510(k) clearance for the DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Delbio Incorporation (Taoyuan County, TW). The FDA issued a Cleared decision on August 23, 2013 after a review of 204 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 Delbio Incorporation devices

FDA 510(k) Submission Details - K130244

510(k) Number K130244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2013
Decision Date August 23, 2013
Days to Decision 204 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 88d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - NBW System, Test, Blood Glucose, Over The Counter

All 308
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K130244.
GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K132966 · Infopia Co, Ltd. · Dec 2013
CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER
K132288 · I-Sens, Inc. · Nov 2013
FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
K131013 · Nova Biomedical Corporation · Oct 2013
CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM
K130696 · I-Sens, Inc. · Aug 2013
ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
K131419 · I-Sens, Inc. · Aug 2013
GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K130181 · Infopia Co, Ltd. · Jul 2013