Cleared Special

K002134 - ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM

K002134 is an FDA 510(k) clearance for ONE TOUCH ULTRA BLOOD GLUCOSE MONITORIN..., manufactured by Selfcare, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Special 510(k) pathway after a 24-day FDA review.

K002134 · Selfcare, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
24d
Days
Class 2
Risk

K002134 is an FDA 510(k) clearance for the ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Selfcare, Inc. (Waltham, US). The FDA issued a Cleared decision on August 7, 2000 after a review of 24 days - a notably fast clearance cycle.

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. Low regulatory complexity 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 - K002134

510(k) Number K002134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2000
Decision Date August 07, 2000
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
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 366
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K002134.
SATURN BLOOD GLUCOSE MONITORING TEST STRIP
K001441 · Lifescan, Inc. · Dec 2000
I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300
K001387 · I-Stat Corp. · Oct 2000
CAMIT DIABETES MANAGEMENT SOFTWARE
K001907 · Roche Diagnostics Corp. · Sep 2000
GENERIC BLOOD GLUCOSE TEST STRIP
K001092 · Inbios Intl., Inc. · Jul 2000
MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K001427 · Selfcare, Inc. · Jun 2000
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K000583 · Selfcare, Inc. · Mar 2000
K002134 · ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
Download PDF FDA Summary Selfcare, Inc.