Cleared Traditional

K132086 - ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM

K132086 is an FDA 510(k) clearance for ON CALL EXPRESS BLOOD GLUCOSE MONITORIN..., manufactured by ACON Laboratories, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K132086 · ACON Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
167d
Days
Class 2
Risk

K132086 is an FDA 510(k) clearance for the ON CALL EXPRESS 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 December 19, 2013 after a review of 167 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all ACON Laboratories, Inc. devices

FDA 510(k) Submission Details - K132086

510(k) Number K132086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2013
Decision Date December 19, 2013
Days to Decision 167 days
Submission Type Traditional
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
79d slower than avg
Panel avg: 88d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 309
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K132086.
ACON ON CALL DIABETES MANAGEMENT SOFTWARE
K131469 · ACON Laboratories, Inc. · Jan 2014
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
K132511 · Abbott Diabetes Care, Inc. · Dec 2013
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
K130284 · ACON Laboratories, Inc. · Dec 2013
SMARTLOG DIABETES MANAGEMENT SOFTWARE
K133346 · I-Sens, Inc. · Dec 2013
HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K132862 · Infopia Co, Ltd. · Dec 2013
GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K132966 · Infopia Co, Ltd. · Dec 2013