Cleared Traditional

K070068 - NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS

K070068 is an FDA 510(k) clearance for NOVA STATSENSOR CREATININE HOSPITAL METER, manufactured by Nova Biomedical Corp.. The device is a Class 2 Chemistry device with product code CGL cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K070068 · Nova Biomedical Corp. · Chemistry device
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May 2007
Decision
119d
Days
Class 2
Risk

K070068 is an FDA 510(k) clearance for the NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTI.... Classified as Electrode, Ion Based, Enzymatic, Creatinine (product code CGL), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on May 7, 2007 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 - K070068

510(k) Number K070068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2007
Decision Date May 07, 2007
Days to Decision 119 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
31d slower than avg
Panel avg: 88d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGL Device Classification - Class 2, Special Controls

Product Code CGL Electrode, Ion Based, Enzymatic, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - CGL Electrode, Ion Based, Enzymatic, Creatinine

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