Cleared Special

K141829 - GLUCOVITAAL H1A BLOOD GLUCOSE MONITORIN...

K141829 is the FDA 510(k) clearance for GLUCOVITAAL H1A BLOOD GLUCOSE MONITORIN... by Ceragem Medisys, Inc.. It is a Class 2 Chemistry device (product code NBW) cleared through the Special 510(k) pathway after a 79-day FDA review.

K141829 · Ceragem Medisys, Inc. · Chemistry device
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Sep 2014
Decision
79d
Days
Class 2
Risk

K141829 is an FDA 510(k) clearance for the GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Ceragem Medisys, Inc. (Cheonan, Chungcheongnam-Do, KR). The FDA issued a Cleared decision on September 24, 2014 after a review of 79 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 Ceragem Medisys, Inc. devices

Submission Details

510(k) Number K141829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2014
Decision Date September 24, 2014
Days to Decision 79 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
9d faster than avg
Panel avg: 88d · This submission: 79d
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 K141829.
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FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT)
K140371 · Abbott Diabetes Care, Inc. · Sep 2014
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K133741 · Roche Diagnostics · Aug 2014
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K130265 · Bayer Healthcare, LLC · Jun 2014
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K133790 · Andon Health Co, Ltd. · May 2014