Cleared Traditional

K133045 - ELEMENT TM LITE BLOOD GLUCOSE MONITORIN...

K133045 is the FDA 510(k) clearance for ELEMENT TM LITE BLOOD GLUCOSE MONITORIN... by Infopia Co, Ltd.. It is a Class 2 Chemistry device (product code NBW) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K133045 · Infopia Co, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
195d
Days
Class 2
Risk

K133045 is an FDA 510(k) clearance for the ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by Infopia Co, Ltd. (Anyang, Kyunggi, KR). The FDA issued a Cleared decision on April 10, 2014 after a review of 195 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 Infopia Co, Ltd. devices

Submission Details

510(k) Number K133045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2013
Decision Date April 10, 2014
Days to Decision 195 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
107d slower than avg
Panel avg: 88d · This submission: 195d
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 K133045.
ACCU-CHEK Performa Blood Glucose Monitoring System
K133741 · Roche Diagnostics · Aug 2014
CONTOUR NEXT EZ BLOOD GLUCOSE METER
K130265 · Bayer Healthcare, LLC · Jun 2014
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
K133790 · Andon Health Co, Ltd. · May 2014
ACON ON CALL DIABETES MANAGEMENT SOFTWARE
K131469 · ACON Laboratories, Inc. · Jan 2014
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
K132511 · Abbott Diabetes Care, Inc. · Dec 2013
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
K130284 · ACON Laboratories, Inc. · Dec 2013