Cleared Traditional

K041478 - BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR

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.

View all Becton Dickinson devices

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
Combination Product No
PCCP Authorized No
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 333
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K041478.
EASYGLUCO IGM-0002 G2
K043512 · American Healthcare, Inc. · Apr 2005
ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100
K041881 · Hypoguard USA, Inc. · Mar 2005
THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS
K041427 · Arkray, Inc. · Nov 2004
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
K042015 · Bayer Healthcare, Diagnostics Division · Sep 2004
GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
K033055 · Diamond Diagnostics, Inc. · Jan 2004
RANDOX RX DAYTONA
K024014 · Randox Laboratories, Ltd. · Dec 2003