Cleared Special

K122110 - ACON ON CALL VIVID PAL BLOOD GLUCOSE MO...

K122110 is the FDA 510(k) clearance for ACON ON CALL VIVID PAL BLOOD GLUCOSE MO... by ACON Laboratories, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Special 510(k) pathway after a 127-day FDA review.

K122110 · ACON Laboratories, Inc. · Chemistry device
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Nov 2012
Decision
127d
Days
Class 2
Risk

K122110 is an FDA 510(k) clearance for the ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on November 21, 2012 after a review of 127 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K122110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2012
Decision Date November 21, 2012
Days to Decision 127 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
39d slower than avg
Panel avg: 88d · This submission: 127d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CGA Glucose Oxidase, Glucose
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 - CGA Glucose Oxidase, Glucose

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