Cleared Traditional

K120921 - CLEVER CHOICE

K120921 is an FDA 510(k) clearance for CLEVER CHOICE, manufactured by Simple Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K120921 · Simple Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
147d
Days
Class 2
Risk

K120921 is an FDA 510(k) clearance for the CLEVER CHOICE. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Simple Diagnostics, Inc. (Naples, US). The FDA issued a Cleared decision on August 21, 2012 after a review of 147 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. 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 Simple Diagnostics, Inc. devices

FDA 510(k) Submission Details - K120921

510(k) Number K120921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2012
Decision Date August 21, 2012
Days to Decision 147 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
59d slower than avg
Panel avg: 88d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00976924 Completed Interventional Industry-sponsored

Clinical Test of Blood Glucose Test Strips

200
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Diabetes
Study design Parallel
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Sponsor Andon Medical Co.,Ltd (industry)
Started 2009-07-01 → Primary completion 2009-07-01
Primary outcome
blood glucose value
Study completed - no results published. This trial concluded in 2009 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 309
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K120921.
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
AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION
K121654 · I-Sens, Inc. · Sep 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
MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL
K120448 · Apex BioTechnology Corp. · Apr 2012