Cleared Traditional

K062187 - BETACHEK GLUCOSE TEST

K062187 is an FDA 510(k) clearance for BETACHEK GLUCOSE TEST, manufactured by National Diagnostic Products. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 966-day FDA review.

K062187 · National Diagnostic Products · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
966d
Days
Class 2
Risk

K062187 is an FDA 510(k) clearance for the BETACHEK GLUCOSE TEST. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by National Diagnostic Products (Sydney, AU). The FDA issued a Cleared decision on March 24, 2009 after a review of 966 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 National Diagnostic Products devices

FDA 510(k) Submission Details - K062187

510(k) Number K062187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2006
Decision Date March 24, 2009
Days to Decision 966 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
878d slower than avg
Panel avg: 88d · This submission: 966d
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 310
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K062187.
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM
K090185 · Taidoc Technology Corporation · Apr 2009
TRUEBALANCE BLOOD GLUCOSE SYSTEM
K090495 · Home Diagnostics, Inc. · Mar 2009
FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247
K090536 · Taidoc Technology Corporation · Mar 2009
G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A
K082201 · U. S. Diagnostics, Inc. · Feb 2009
CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)
K083468 · I-Sens, Inc. · Feb 2009
EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM
K081796 · Eps Bio Technology Corp. · Jan 2009