Cleared Special

K161867 - On Call Pro Blood Glucose Monitoring System

K161867 is an FDA 510(k) clearance for On Call Pro Blood Glucose Monitoring System, manufactured by Acon Laboratories. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 29-day FDA review.

K161867 · Acon Laboratories · Chemistry device
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Aug 2016
Decision
29d
Days
Class 2
Risk

K161867 is an FDA 510(k) clearance for the On Call Pro Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Acon Laboratories (San Diego, US). The FDA issued a Cleared decision on August 5, 2016 after a review of 29 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Acon Laboratories devices

FDA 510(k) Submission Details - K161867

510(k) Number K161867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2016
Decision Date August 05, 2016
Days to Decision 29 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
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 420
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