Cleared Special

K121654 - AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION

K121654 is an FDA 510(k) clearance for AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, manufactured by I-Sens, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Special 510(k) pathway after a 92-day FDA review.

K121654 · I-Sens, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
92d
Days
Class 2
Risk

K121654 is an FDA 510(k) clearance for the AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONT.... Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by I-Sens, Inc. (Seoul, KR). The FDA issued a Cleared decision on September 5, 2012 after a review of 92 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all I-Sens, Inc. devices

FDA 510(k) Submission Details - K121654

510(k) Number K121654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2012
Decision Date September 05, 2012
Days to Decision 92 days
Submission Type Special
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
4d slower than avg
Panel avg: 88d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
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 - CGA Glucose Oxidase, Glucose

All 300
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K121654.
BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
K113636 · Philosys Co., Ltd. · Mar 2013
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM
K121706 · Foracare, Inc. · Jan 2013
ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM
K122110 · ACON Laboratories, Inc. · Nov 2012
CLEVER CHOICE
K120921 · Simple Diagnostics, Inc. · Aug 2012
CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
K120759 · I-Sens, Inc. · Jun 2012
ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
K113670 · Infopia Co, Ltd. · May 2012