Cleared Special

K100701 - SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277

K100701 is an FDA 510(k) clearance for SMARTEST PERSONA BLOOD GLUCOSE TEST SYT..., manufactured by Biotest Medical Corp.. The device is a Class 2 Chemistry device with product code NBW cleared through the Special 510(k) pathway after a 27-day FDA review.

K100701 · Biotest Medical Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
27d
Days
Class 2
Risk

K100701 is an FDA 510(k) clearance for the SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Biotest Medical Corp. (Taichung, TW). The FDA issued a Cleared decision on April 8, 2010 after a review of 27 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.

FDA 510(k) Submission Details - K100701

510(k) Number K100701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2010
Decision Date April 08, 2010
Days to Decision 27 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
62d faster than avg
Panel avg: 89d · This submission: 27d
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 513
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K100701.
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K100701 · SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277
Download PDF FDA Summary Biotest Medical Corp.