Cleared Traditional

K100806 - DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM (FDA 510(k) Clearance)

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

K100806 · Delbio Incorporation · Chemistry device
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Sep 2011
Decision
543d
Days
Class 2
Risk

K100806 is an FDA 510(k) clearance for the DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Delbio Incorporation (Taoyuan, TW). The FDA issued a Cleared decision on September 16, 2011 after a review of 543 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Delbio Incorporation devices

Submission Details

510(k) Number K100806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2010
Decision Date September 16, 2011
Days to Decision 543 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
455d slower than avg
Panel avg: 88d · This submission: 543d
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 507
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