Cleared Traditional

PRODIGY (K053593) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K053593 · Diagnostic Devices, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
195d
Days
Class 2
Risk

K053593 is an FDA 510(k) clearance for the PRODIGY. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Diagnostic Devices, Inc. (Deer Field, US). The FDA issued a Cleared decision on July 6, 2006 after a review of 195 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. 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. Standard predicate reliance. 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 Diagnostic Devices, Inc. devices

Submission Details

510(k) Number K053593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2005
Decision Date July 06, 2006
Days to Decision 195 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
107d slower than avg
Panel avg: 88d · This submission: 195d
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 182
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K053593.
CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM
K063212 · Taidoc Technology Corporation · Nov 2006
EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM
K062235 · Taidoc Technology Corporation · Sep 2006
ACCU-CHEK AVIVA TEST STRIPS
K060620 · Roche Diagnostics Corp. · Aug 2006
ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207
K061181 · Taidoc Technology Corporation · Jul 2006
CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS
K051936 · Taidoc Technology Corporation · Aug 2005
CLEVER CHEK TD-4225, MODEL TD-4225
K051854 · Taidoc Technology Corporation · Aug 2005