Cleared Special

Freestyle Freedom Blood Glucose Monitoring Sytem (K152442) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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.

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Submission Details

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.

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 165
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K152442.
Smart Dongle Blood Glucose Monitoring System
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AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System
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FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
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U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System
K151100 · Taidoc Technology Corporation · Sep 2015
FreeStyle Lite Blood Glucose Monitoring System
K150332 · Abbott Laboratories · Jun 2015
FreeStyle Freedom Lite Blood Glucose Monitoring System
K150531 · Abbott Laboratories · Jun 2015