Cleared Special

ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 (K062434) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K062434 · Agamatrix · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
84d
Days
Class 2
Risk

K062434 is an FDA 510(k) clearance for the ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Agamatrix (Salem, US). The FDA issued a Cleared decision on November 13, 2006 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Agamatrix devices

Submission Details

510(k) Number K062434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2006
Decision Date November 13, 2006
Days to Decision 84 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

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 166
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K062434.
CLEVER CHEK TD-4230 BLOOD GLUCOSE MONITORING SYSTEM, RD-4230, SURECHEK BLOOD GLUCOSE MONITORING SYSTEM, SMS-4230
K070472 · Taidoc Technology Corporation · Mar 2007
CLEVER CHEK TD-3213/ CLEVER CHEK TD-3215/ DR. T TD-3216/ CLEVER CHEK TD-3217/ CLEVER CHEK TD-3250 BLOOD GLUCOSE PLUS BLO
K062800 · Taidoc Technology Corporation · Jan 2007
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