Cleared Special

ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM (K103278) - FDA 510(k) Clearance

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

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K103278 · I-Sens, Inc. · Chemistry device
Download Printable Device Report (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.

View all I-Sens, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 88d · This submission: 357d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.
ABL90 FLEX PLUS System
K252488 · Radiometer Medicals Aps · May 2026
YSI 2900C Biochemistry Analyzer
K210933 · Ysi, Inc. · Sep 2024
EasyStat 300
K220328 · Medica Corporation · Jul 2024
Cholestech LDX ™ System
K223179 · Alere San Diego, Inc. · Sep 2023
i-STAT G cartridge with the i-STAT 1 System
K223755 · Abbott Point of Care, Inc. · Sep 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K223710 · Abbott Point of Care, Inc. · Jul 2023