Cleared Traditional

K070704 - TRILOGY ANALYZER

K070704 is the FDA 510(k) clearance for TRILOGY ANALYZER by Drew Scientific, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K070704 · Drew Scientific, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
122d
Days
Class 2
Risk

K070704 is an FDA 510(k) clearance for the TRILOGY ANALYZER. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Drew Scientific, Inc. (North Attleboro, US). The FDA issued a Cleared decision on July 13, 2007 after a review of 122 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 Drew Scientific, Inc. devices

Submission Details

510(k) Number K070704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2007
Decision Date July 13, 2007
Days to Decision 122 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 88d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 191
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K070704.
CLEVER CHEK AND AUDIOCHEK BLOOD GLUCOSE MONITORING SYSTEMS, MODEL TD-4237
K081609 · Taidoc Technology Corporation · Jul 2008
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K073648 · Apex BioTechnology Corp. · Apr 2008
EASYRA CLINICAL CHEMISTRY ANALYZER
K070057 · Medica Corp. · Aug 2007
NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
K070960 · Nova Biomedical Corp. · 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