Cleared Traditional

K043245 - EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM

K043245 is an FDA 510(k) clearance for EPS EASY PAIN SUPREME SELF MONITORING B..., manufactured by Eps Bio Technology Corp.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K043245 · Eps Bio Technology Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
157d
Days
Class 2
Risk

K043245 is an FDA 510(k) clearance for the EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Eps Bio Technology Corp. (Flagstaff, US). The FDA issued a Cleared decision on April 29, 2005 after a review of 157 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 Eps Bio Technology Corp. devices

FDA 510(k) Submission Details - K043245

510(k) Number K043245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2004
Decision Date April 29, 2005
Days to Decision 157 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
69d slower than avg
Panel avg: 88d · This submission: 157d
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 332
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K043245.
Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM
K050182 · Biomedix, Inc. · Aug 2005
GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM
K051285 · Infopia Co, Ltd. · Aug 2005
ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
K043197 · Lifescan, Inc. · May 2005
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