Cleared Traditional

K052469 - GLUCOPACK

K052469 is an FDA 510(k) clearance for GLUCOPACK, manufactured by Healthpia America Corp.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K052469 · Healthpia America Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
270d
Days
Class 2
Risk

K052469 is an FDA 510(k) clearance for the GLUCOPACK. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Healthpia America Corp. (Palisades Park, US). The FDA issued a Cleared decision on June 5, 2006 after a review of 270 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 Healthpia America Corp. devices

FDA 510(k) Submission Details - K052469

510(k) Number K052469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2005
Decision Date June 05, 2006
Days to Decision 270 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
182d slower than avg
Panel avg: 88d · This submission: 270d
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 280
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K052469.
ACCU-CHEK AVIVA TEST STRIPS
K060620 · Roche Diagnostics Corp. · Aug 2006
ELEMENT BLOOD GLUCOSE TEST SYSTEM
K060793 · Home Diagnostics, Inc. · Jul 2006
ACHTUNG BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4207
K061181 · Taidoc Technology Corporation · Jul 2006
ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
K061118 · Lifescan, Inc. · May 2006
G4, MODEL IGM-0004
K051651 · U. S. Diagnostics, Inc. · Apr 2006
FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001
K051839 · Abbott Diabetes Care, Inc. · Mar 2006