Cleared Special

K101597 - WAVESENSE DIABETES MANAGER MODEL VERSIO...

K101597 is an FDA 510(k) clearance for WAVESENSE DIABETES MANAGER MODEL VERSIO..., manufactured by Agamatrix. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 132-day FDA review.

K101597 · Agamatrix · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
132d
Days
Class 2
Risk

K101597 is an FDA 510(k) clearance for the WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4. 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 October 18, 2010 after a review of 132 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K101597

510(k) Number K101597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2010
Decision Date October 18, 2010
Days to Decision 132 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
44d slower than avg
Panel avg: 88d · This submission: 132d
Pathway characteristics
Modification to existing cleared device.

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 275
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K101597.
ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
K093745 · Lifescan, Inc. · Feb 2011
ON CALL PLUS DIABETES MONITORING SOFTWARE
K101371 · ACON Laboratories, Inc. · Jan 2011
PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
K100937 · I-Sens, Inc. · Dec 2010
ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER
K092875 · Taidoc Technology Corporation · Aug 2010
FORA G30A BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4241
K100732 · Taidoc Technology Corporation · Jul 2010
EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031
K101457 · Eps Bio Technology Corp. · Jul 2010