Cleared Traditional

K022580 - BACTON DICKINSON LATITUDE BLOOD GLUCOSE...

K022580 is an FDA 510(k) clearance for BACTON DICKINSON LATITUDE BLOOD GLUCOSE..., manufactured by Becton, Dickinson & CO. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K022580 · Becton, Dickinson & CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
65d
Days
Class 2
Risk

K022580 is an FDA 510(k) clearance for the BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (Franklin Lakes, US). The FDA issued a Cleared decision on October 9, 2002 after a review of 65 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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FDA 510(k) Submission Details - K022580

510(k) Number K022580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2002
Decision Date October 09, 2002
Days to Decision 65 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
23d faster than avg
Panel avg: 88d · This submission: 65d
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 217
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K022580.
ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS
K031472 · Lifescan, Inc. · Aug 2003
ASCENSIA BREEZE BLOOD GLUCOSE METER
K024062 · Bayer Corp. · Mar 2003
SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
K023194 · Lifescan, Inc. · Oct 2002
IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)
K022158 · Instrumentation Laboratory CO · Sep 2002
ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM
K021943 · Lifescan, Inc. · Jun 2002
DIABETES ASSISTANT SOFTWARE
K014139 · Roche Diagnostics Corp. · Mar 2002