Cleared Special

K152442 - Freestyle Freedom Blood Glucose Monitoring Sytem

K152442 is an FDA 510(k) clearance for Freestyle Freedom Blood Glucose Monitor..., manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 112-day FDA review.

K152442 · Abbott Laboratories · Chemistry device
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Dec 2015
Decision
112d
Days
Class 2
Risk

K152442 is an FDA 510(k) clearance for the Freestyle Freedom Blood Glucose Monitoring Sytem. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Abbott Laboratories (Alameda, US). The FDA issued a Cleared decision on December 17, 2015 after a review of 112 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K152442

510(k) Number K152442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2015
Decision Date December 17, 2015
Days to Decision 112 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 88d · This submission: 112d
Pathway characteristics
Modification to existing cleared device.

NBW Device Classification - Class 2, Special Controls

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 504
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K152442.
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K150833 · Andon Health Co, Ltd. · Dec 2015
Gmate Origin Blood Glucose Monitoring System
K151658 · Philosys, Inc. · Dec 2015