Cleared Traditional

FORA V10 BLOOD GLUCOSE MONITORING SYSTEM (K121706) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121706 · Foracare, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
220d
Days
Class 2
Risk

K121706 is an FDA 510(k) clearance for the FORA V10 BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Foracare, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on January 14, 2013 after a review of 220 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 Foracare, Inc. devices

Submission Details

510(k) Number K121706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2012
Decision Date January 14, 2013
Days to Decision 220 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 88d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 115
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K121706.
Stat Profile Prime Plus Analyzer System
K180340 · Nova Biomedical Corporation · Sep 2018
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)
K160402 · Instrumentation Laboratory CO · Dec 2016
GEM Premier 3000
K161818 · Instrumentation Laboratory CO · Sep 2016
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
K103842 · Beckman Coulter, Inc. · Apr 2011
FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM
K100405 · Taidoc Technology Corporation · Jul 2010
FORA V20 BLOOD GLUCOSE MONITORING SYSTEM
K100406 · Taidoc Technology Corporation · May 2010