Cleared Traditional

K041478 - BD LOGIC BLOOD GLUCOSE MONITOR AND PARA...

K041478 is an FDA 510(k) clearance for BD LOGIC BLOOD GLUCOSE MONITOR AND PARA..., manufactured by Becton Dickinson. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K041478 · Becton Dickinson · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
147d
Days
Class 2
Risk

K041478 is an FDA 510(k) clearance for the BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Becton Dickinson (Franklin Lakes, US). The FDA issued a Cleared decision on October 28, 2004 after a review of 147 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.

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FDA 510(k) Submission Details - K041478

510(k) Number K041478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2004
Decision Date October 28, 2004
Days to Decision 147 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
59d slower than avg
Panel avg: 88d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 244
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K041478.
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K033055 · Diamond Diagnostics, Inc. · Jan 2004
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K024014 · Randox Laboratories, Ltd. · Dec 2003
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