Cleared Traditional

K091815 - SUPERCHECK 1 BLOOD GLUCOSE MONITORING S...

K091815 is the FDA 510(k) clearance for SUPERCHECK 1 BLOOD GLUCOSE MONITORING S... by Biotest Medical Corp.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K091815 · Biotest Medical Corp. · Chemistry device
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Nov 2009
Decision
151d
Days
Class 2
Risk

K091815 is an FDA 510(k) clearance for the SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Biotest Medical Corp. (Fairfax, US). The FDA issued a Cleared decision on November 16, 2009 after a review of 151 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biotest Medical Corp. devices

Submission Details

510(k) Number K091815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2009
Decision Date November 16, 2009
Days to Decision 151 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 88d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K091815.
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244
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K092099 · Taidoc Technology Corporation · Dec 2009
DIDGET BLOOD GLUCOSE METER, MODEL 6181
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BLOOD GLUCOSE MONITORING SYSTEM, MODEL FORA G90/TD-4234
K091898 · Taidoc Technology Corporation · Sep 2009
U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222
K090188 · Taidoc Technology Corporation · Jul 2009
FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247
K090404 · Taidoc Technology Corporation · Jun 2009