Cleared Special

K131469 - ACON ON CALL DIABETES MANAGEMENT SOFTWARE

K131469 is an FDA 510(k) clearance for ACON ON CALL DIABETES MANAGEMENT SOFTWARE, manufactured by ACON Laboratories, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 230-day FDA review.

K131469 · ACON Laboratories, Inc. · Chemistry device
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Jan 2014
Decision
230d
Days
Class 2
Risk

K131469 is an FDA 510(k) clearance for the ACON ON CALL DIABETES MANAGEMENT SOFTWARE. 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 January 6, 2014 after a review of 230 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. 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 ACON Laboratories, Inc. devices

FDA 510(k) Submission Details - K131469

510(k) Number K131469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2013
Decision Date January 06, 2014
Days to Decision 230 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
142d slower than avg
Panel avg: 88d · This submission: 230d
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 309
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