Cleared Traditional

K070255 - NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM

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

K070255 · Nova Biomedical Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 190
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K070255.
ADVOCATE REDI-CODE BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4223E
K072039 · Taidoc Technology Corporation · Oct 2007
REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM
K072489 · Taidoc Technology Corporation · Sep 2007
CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0
K070941 · Taidoc Technology Corporation · Jun 2007
ACCU-CHEK PERFORMA SYSTEM
K070585 · Roche Diagnostics Corp. · May 2007
ACCU-CHEK SMART PIX
K062395 · Roche Diagnostics Corp. · May 2007
ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
K070641 · Taidoc Technology Corporation · Apr 2007