Cleared Special

K103278 - ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM

Also marketed or referenced as:
ACURA PLUS BLOOD GLUCOSE METER ACURA CONTROL SOLUTION

K103278 is an FDA 510(k) clearance for ACURA PLUS 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 357-day FDA review.

K103278 · I-Sens, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
357d
Days
Class 2
Risk

K103278 is an FDA 510(k) clearance for the ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM. 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 October 28, 2011 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K103278

510(k) Number K103278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2010
Decision Date October 28, 2011
Days to Decision 357 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
268d slower than avg
Panel avg: 89d · This submission: 357d
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 400
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K103278.
GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL
K113547 · Apex BioTechnology Corp. · Mar 2012
AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM
K103116 · Bestgen Biotech Corp. · Mar 2012
GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
K113208 · Apex BioTechnology Corp. · Jan 2012
GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM
K102316 · Broadmaster Biotech Corporation · Oct 2011
ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM
K111371 · ACON Laboratories, Inc. · Oct 2011
EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
K111728 · Eps Bio Technology Corp. · Sep 2011
K103278 · ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM
Download PDF FDA Summary I-Sens, Inc.