Cleared Traditional

K021960 - PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K021960 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
63d
Days
Class 2
Risk

K021960 is an FDA 510(k) clearance for the PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Abbott Laboratories (Bedford, US). The FDA issued a Cleared decision on August 16, 2002 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K021960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2002
Decision Date August 16, 2002
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFR Glucose Dehydrogenase, 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.