Cleared Traditional

K062538 - EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM

K062538 is an FDA 510(k) clearance for EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM, manufactured by Diacare Corp.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K062538 · Diacare Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
244d
Days
Class 2
Risk

K062538 is an FDA 510(k) clearance for the EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Diacare Corp. (Great Neck, US). The FDA issued a Cleared decision on April 30, 2007 after a review of 244 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 Diacare Corp. devices

FDA 510(k) Submission Details - K062538

510(k) Number K062538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2006
Decision Date April 30, 2007
Days to Decision 244 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
156d slower than avg
Panel avg: 88d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBW Device Classification - Class 2, Special Controls

Product Code NBW System, Test, Blood Glucose, Over The Counter
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 - NBW System, Test, Blood Glucose, Over The Counter

All 310
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K062538.
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ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223
K070641 · Taidoc Technology Corporation · Apr 2007
CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-4230
K070472 · Taidoc Technology Corporation · Mar 2007