Cleared Traditional

K070524 - MICRODOT BLOOD GLUCOSE MONITORING SYSTEM

K070524 is the FDA 510(k) clearance for MICRODOT BLOOD GLUCOSE MONITORING SYSTEM by Cambridge Sensors Limited. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K070524 · Cambridge Sensors Limited · Chemistry device
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Optimized for regulatory review, auditing and printing
Jun 2007
Decision
119d
Days
Class 2
Risk

K070524 is an FDA 510(k) clearance for the MICRODOT BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Cambridge Sensors Limited (Huntingdon, Cambridgeshire, GB). The FDA issued a Cleared decision on June 22, 2007 after a review of 119 days - within the typical 510(k) review window.

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 Cambridge Sensors Limited devices

Submission Details

510(k) Number K070524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2007
Decision Date June 22, 2007
Days to Decision 119 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
31d slower than avg
Panel avg: 88d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 236
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K070524.
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K072039 · Taidoc Technology Corporation · Oct 2007
REVOLUTION TD-4229 BLOOD GLUCOSE MONITORING SYSTEM
K072489 · Taidoc Technology Corporation · Sep 2007
CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0
K070941 · Taidoc Technology Corporation · Jun 2007
NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
K070255 · Nova Biomedical Corp. · Jun 2007
ACCU-CHEK PERFORMA SYSTEM
K070585 · Roche Diagnostics Corp. · May 2007