Cleared Special

On Call Express Mobile Blood Glucose Monitoring System (K180196) - FDA 510(k) Clearance

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

K180196 · ACON Laboratories, Inc. · Chemistry device
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Mar 2018
Decision
42d
Days
Class 2
Risk

K180196 is an FDA 510(k) clearance for the On Call Express Mobile Blood Glucose Monitoring System. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on March 7, 2018 after a review of 42 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, Inc. devices

Submission Details

510(k) Number K180196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2018
Decision Date March 07, 2018
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
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 173
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K180196.
Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus
K173139 · Bionime Corporation · Jun 2018
POGO Automatic Blood Glucose Monitoring System
K181316 · Intuity Medical, Inc. · Jun 2018
Dario LC Blood Glucose Monitoring System
K172723 · Labstyle Innovation, Ltd. · Mar 2018
iHealth Align Gluco-Monitoring System (BG1)
K170231 · Andon Health Co, Ltd. · Sep 2017
Smart Dongle Blood Glucose Monitoring System
K162382 · Taidoc Technology Corporation · Apr 2017
AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System
K153561 · Andon Health Co, Ltd. · Feb 2017