Cleared Traditional

K033627 - Q.STEPS BIOMETER G BLOOD GLUCOSE MONITO...

K033627 is an FDA 510(k) clearance for Q.STEPS BIOMETER G BLOOD GLUCOSE MONITO..., manufactured by Biomedix, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K033627 · Biomedix, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
184d
Days
Class 2
Risk

K033627 is an FDA 510(k) clearance for the Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Biomedix, Inc. (Fremont, US). The FDA issued a Cleared decision on May 21, 2004 after a review of 184 days - an extended review 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: 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 Biomedix, Inc. devices

FDA 510(k) Submission Details - K033627

510(k) Number K033627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2003
Decision Date May 21, 2004
Days to Decision 184 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
96d slower than avg
Panel avg: 88d · This submission: 184d
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 259
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K033627.
ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
K043197 · Lifescan, Inc. · May 2005
EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM
K043245 · Eps Bio Technology Corp. · Apr 2005
THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS
K041427 · Arkray, Inc. · Nov 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
ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS
K031472 · Lifescan, Inc. · Aug 2003