Cleared Special

K132072 - TRUE METRIX SELF-MONITORING BLOOD GLUCO...

K132072 is the FDA 510(k) clearance for TRUE METRIX SELF-MONITORING BLOOD GLUCO... by Nipro Diagnostics, Inc.. It is a Class 2 Chemistry device (product code NBW) cleared through the Special 510(k) pathway after a 43-day FDA review.

K132072 · Nipro Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
43d
Days
Class 2
Risk

K132072 is an FDA 510(k) clearance for the TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL.... Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Nipro Diagnostics, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on August 15, 2013 after a review of 43 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 Nipro Diagnostics, Inc. devices

Submission Details

510(k) Number K132072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2013
Decision Date August 15, 2013
Days to Decision 43 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
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 236
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K132072.
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
K130284 · ACON Laboratories, Inc. · Dec 2013
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
K132086 · ACON Laboratories, Inc. · Dec 2013
FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
K131013 · Nova Biomedical Corporation · Oct 2013
FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM
K124040 · Taidoc Technology Corporation · May 2013
FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001
K123089 · Abbott Laboratories · Apr 2013
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
K130138 · Roche Diagnostics Corp. · Mar 2013