Cleared Traditional

K103115 - PRODIGY DIABETES MANAGEMENT SOFTWARE

K103115 is an FDA 510(k) clearance for PRODIGY DIABETES MANAGEMENT SOFTWARE, manufactured by Prodigy Diabetes Care, LLC. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K103115 · Prodigy Diabetes Care, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
356d
Days
Class 2
Risk

K103115 is an FDA 510(k) clearance for the PRODIGY DIABETES MANAGEMENT SOFTWARE. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Prodigy Diabetes Care, LLC (Crofton, US). The FDA issued a Cleared decision on October 12, 2011 after a review of 356 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 Prodigy Diabetes Care, LLC devices

FDA 510(k) Submission Details - K103115

510(k) Number K103115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2010
Decision Date October 12, 2011
Days to Decision 356 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
268d slower than avg
Panel avg: 88d · This submission: 356d
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 457
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K103115.
IGLUCOSE SYSTEM
K111932 · Positiveid Corporation · Nov 2011
SWEETSPOT DIABETES DATA MANAGEMENT SERVICE
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K103021 · Infopia Co, Ltd. · Nov 2011
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
K112738 · Andon Medical Co., Ltd. · Sep 2011
COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION
K103396 · I-Sens, Inc. · Sep 2011
EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM
K110435 · U. S. Diagnostics, Inc. · Sep 2011