Cleared Traditional

K133584 - IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM

K133584 is an FDA 510(k) clearance for IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM, manufactured by Eoshealth, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K133584 · Eoshealth, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
291d
Days
Class 2
Risk

K133584 is an FDA 510(k) clearance for the IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Eoshealth, Inc. (Austin, US). The FDA issued a Cleared decision on September 8, 2014 after a review of 291 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 Eoshealth, Inc. devices

FDA 510(k) Submission Details - K133584

510(k) Number K133584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2013
Decision Date September 08, 2014
Days to Decision 291 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
203d slower than avg
Panel avg: 88d · This submission: 291d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K133584.
MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System
K143750 · Apex BioTechnology Corp. · May 2015
BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System
K142302 · Polymer Technology Systems, Inc. · Oct 2014
GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System
K142336 · Arkray Factory, Inc. · Sep 2014
ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM
K124021 · Arkray Factory, Inc. · Jun 2014
AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM
K131750 · Apex BioTechnology Corp. · Mar 2014
ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE
K120615 · Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen · May 2013