Cleared Special

K150052 - TRUE METRIX AIR Self-Monitoring Blood G...

K150052 is the FDA 510(k) clearance for TRUE METRIX AIR Self-Monitoring Blood G... by Nipro Diagnostics, Inc.. It is a Class 2 Chemistry device (product code NBW) cleared through the Special 510(k) pathway after a 73-day FDA review.

K150052 · Nipro Diagnostics, Inc. · Chemistry device
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Mar 2015
Decision
73d
Days
Class 2
Risk

K150052 is an FDA 510(k) clearance for the TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Pro.... 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 March 26, 2015 after a review of 73 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 K150052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2015
Decision Date March 26, 2015
Days to Decision 73 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
15d faster than avg
Panel avg: 88d · This submission: 73d
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
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K140371 · Abbott Diabetes Care, Inc. · Sep 2014
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K133741 · Roche Diagnostics · Aug 2014