Cleared Traditional

K130284 - ON CALL SHARP BLOOD GLUCOSE MONITORING ...

K130284 is the FDA 510(k) clearance for ON CALL SHARP BLOOD GLUCOSE MONITORING ... by ACON Laboratories, Inc.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K130284 · ACON Laboratories, Inc. · Chemistry device
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Dec 2013
Decision
318d
Days
Class 2
Risk

K130284 is an FDA 510(k) clearance for the ON CALL SHARP 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 20, 2013 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K130284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2013
Decision Date December 20, 2013
Days to Decision 318 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
230d slower than avg
Panel avg: 88d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 181
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K130284.
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