Cleared Special

K070960 - NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM

K070960 is an FDA 510(k) clearance for NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL ..., manufactured by Nova Biomedical Corp.. The device is a Class 2 Chemistry device with product code CGA cleared through the Special 510(k) pathway after a 97-day FDA review.

K070960 · Nova Biomedical Corp. · Chemistry device
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Jul 2007
Decision
97d
Days
Class 2
Risk

K070960 is an FDA 510(k) clearance for the NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on July 11, 2007 after a review of 97 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K070960

510(k) Number K070960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2007
Decision Date July 11, 2007
Days to Decision 97 days
Submission Type Special
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
9d slower than avg
Panel avg: 88d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
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 - CGA Glucose Oxidase, Glucose

All 382
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K070960.
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TRILOGY ANALYZER
K070704 · Drew Scientific, Inc. · Jul 2007
GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM
K062799 · Apex BioTechnology Corp. · Feb 2007
NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
K063821 · Nova Biomedical Corp. · Jan 2007
EUKARE
K062892 · Eumed Biotechnology Co., Ltd. · Jan 2007
K070960 · NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
Download PDF Nova Biomedical Corp.