Cleared Traditional

K122340 - PRODIGY CHOICE

K122340 is an FDA 510(k) clearance for PRODIGY CHOICE, 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 481-day FDA review.

K122340 · Prodigy Diabetes Care, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
481d
Days
Class 2
Risk

K122340 is an FDA 510(k) clearance for the PRODIGY CHOICE. 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 November 26, 2013 after a review of 481 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Prodigy Diabetes Care, LLC devices

FDA 510(k) Submission Details - K122340

510(k) Number K122340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2012
Decision Date November 26, 2013
Days to Decision 481 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
393d slower than avg
Panel avg: 88d · This submission: 481d
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 455
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K122340.
SMARTLOG DIABETES MANAGEMENT SOFTWARE
K133346 · I-Sens, Inc. · Dec 2013
HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K132862 · Infopia Co, Ltd. · Dec 2013
GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K132966 · Infopia Co, Ltd. · Dec 2013
GLB BENECHECK PREMIUM GLU MONITORING SYSTEM
K123090 · General Life Biotechnology Co., Ltd. · Nov 2013
CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER
K132288 · I-Sens, Inc. · Nov 2013
AGAMATRIX HEALTH MANAGER
K132821 · Agamatrix, Inc. · Nov 2013