Cleared Traditional

K083273 - MICRODOT XTRA

K083273 is the FDA 510(k) clearance for 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 378-day FDA review.

K083273 · Cambridge Sensors Limited · Chemistry device
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Nov 2009
Decision
378d
Days
Class 2
Risk

K083273 is an FDA 510(k) clearance for the 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 November 19, 2009 after a review of 378 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 K083273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2008
Decision Date November 19, 2009
Days to Decision 378 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
290d slower than avg
Panel avg: 88d · This submission: 378d
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
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