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.

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 510
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K131469 · ACON ON CALL DIABETES MANAGEMENT SOFTWARE
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