Cleared Traditional

K130696 - CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM

Also marketed or referenced as:
CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM

K130696 is an FDA 510(k) clearance for CARESENS N LINK BLOOD GLUCOSE MONITORIN..., manufactured by I-Sens, Inc.. The device is a Class 2 Chemistry device with product code NBW cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K130696 · I-Sens, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
160d
Days
Class 2
Risk

K130696 is an FDA 510(k) clearance for the CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM. Classified as System, Test, Blood Glucose, Over The Counter (product code NBW), Class II - Special Controls.

Submitted by I-Sens, Inc. (Seoul, Korea, KR). The FDA issued a Cleared decision on August 21, 2013 after a review of 160 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 I-Sens, Inc. devices

FDA 510(k) Submission Details - K130696

510(k) Number K130696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2013
Decision Date August 21, 2013
Days to Decision 160 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 88d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 420
Devices cleared under the same product code (NBW) and FDA review panel - the closest regulatory comparables to K130696.
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR
K122370 · Bayer Healthcare · Sep 2013
ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
K131363 · Cilag GmbH International · Aug 2013
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
K130244 · Delbio Incorporation · Aug 2013
EBCHEK BLOOD GLUCOSE MONITORING SYSTEM
K122181 · Visgeneer, Inc. · Aug 2013
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
K132072 · Nipro Diagnostics, Inc. · Aug 2013
ACCU-CHEK AVIVA PLUS TEST STRIP
K131029 · Roche Diagnostics Operations, Inc. · Aug 2013