Cleared Traditional

K111874 - FREESTYLE INSULINX BLOOD GLUCOSE MONITO...

K111874 is an FDA 510(k) clearance for FREESTYLE INSULINX BLOOD GLUCOSE MONITO..., manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code LFR cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K111874 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
230d
Days
Class 2
Risk

K111874 is an FDA 510(k) clearance for the FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Abbott Laboratories (Alameda, US). The FDA issued a Cleared decision on February 16, 2012 after a review of 230 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K111874

510(k) Number K111874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2011
Decision Date February 16, 2012
Days to Decision 230 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 88d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFR Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LFR Glucose Dehydrogenase, Glucose

All 55
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K111874.
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