Cleared Traditional

DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM (K130244) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 177
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K130244.
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K123089 · Abbott Laboratories · Apr 2013
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