Cleared Special

FreeStyle Lite Blood Glucose Monitoring System (K150332) - FDA 510(k) Clearance

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

K150332 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
115d
Days
Class 2
Risk

K150332 is an FDA 510(k) clearance for the FreeStyle Lite Blood Glucose Monitoring System. 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 June 5, 2015 after a review of 115 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

Submission Details

510(k) Number K150332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2015
Decision Date June 05, 2015
Days to Decision 115 days
Submission Type Special
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
27d slower than avg
Panel avg: 88d · This submission: 115d
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 K150332.
FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
K161738 · Taidoc Technology Corporation · Nov 2016
Freestyle Freedom Blood Glucose Monitoring Sytem
K152442 · Abbott Laboratories · Dec 2015
U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System
K151100 · Taidoc Technology Corporation · Sep 2015
FreeStyle Freedom Lite Blood Glucose Monitoring System
K150531 · Abbott Laboratories · Jun 2015
FORA GD43 Blood Glucose Monitoring System
K143467 · Taidoc Technology Corporation · May 2015
ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
K141867 · Roche Diagnostics · Mar 2015