Cleared Traditional

K102383 - MICRODOT & MICRODOT XTRA

K102383 is the FDA 510(k) clearance for MICRODOT & MICRODOT XTRA by Cambridge Sensors Limited. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 522-day FDA review.

K102383 · Cambridge Sensors Limited · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
522d
Days
Class 2
Risk

K102383 is an FDA 510(k) clearance for the MICRODOT & MICRODOT XTRA. 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 January 27, 2012 after a review of 522 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Cambridge Sensors Limited devices

Submission Details

510(k) Number K102383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2010
Decision Date January 27, 2012
Days to Decision 522 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
434d slower than avg
Panel avg: 88d · This submission: 522d
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 K102383.
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
K120568 · Abbott Diabetes Care, Inc. · Mar 2012
NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS
K112638 · Nova Biomedical Corporation · Mar 2012
FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM
K111890 · Taidoc Technology Corporation · Feb 2012
AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III
K113098 · Apex BioTechnology Corp. · Jan 2012
GLUCOSE TEST SYSTEM
K113137 · Roche Diagnostics · Jan 2012
FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K101926 · Taidoc Technology Corporation · Dec 2011