Cleared Special

K023194 - SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL ...

K023194 is the FDA 510(k) clearance for SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL ... by Lifescan, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Special 510(k) pathway after a 29-day FDA review.

K023194 · Lifescan, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
29d
Days
Class 2
Risk

K023194 is an FDA 510(k) clearance for the SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Lifescan, Inc. (Milpitas, US). The FDA issued a Cleared decision on October 24, 2002 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lifescan, Inc. devices

Submission Details

510(k) Number K023194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2002
Decision Date October 24, 2002
Days to Decision 29 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 133
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K023194.
GEM PREMIER 3000
K052121 · Instrumentation Laboratory CO · Oct 2005
RANDOX RX DAYTONA
K024014 · Randox Laboratories, Ltd. · Dec 2003
ASCENSIA BREEZE BLOOD GLUCOSE METER
K024062 · Bayer Corp. · Mar 2003
BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM
K022580 · Becton, Dickinson & CO · Oct 2002
IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)
K022158 · Instrumentation Laboratory CO · Sep 2002
DIABETES ASSISTANT SOFTWARE
K014139 · Roche Diagnostics Corp. · Mar 2002