Cleared Traditional

K070255 - NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002

K070255 is an FDA 510(k) clearance for NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, manufactured by Nova Biomedical Corp.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K070255 · Nova Biomedical Corp. · Chemistry device
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Jun 2007
Decision
138d
Days
Class 2
Risk

K070255 is an FDA 510(k) clearance for the NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on June 13, 2007 after a review of 138 days - within the typical 510(k) review window.

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 Nova Biomedical Corp. devices

FDA 510(k) Submission Details - K070255

510(k) Number K070255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2007
Decision Date June 13, 2007
Days to Decision 138 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 88d · This submission: 138d
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 347
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