Cleared Special

K001427 - MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

K001427 is an FDA 510(k) clearance for MODIFICATION TO FASTTAKE COMPACT BLOOD ..., 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 28-day FDA review.

K001427 · Selfcare, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
28d
Days
Class 2
Risk

K001427 is an FDA 510(k) clearance for the MODIFICATION TO FASTTAKE COMPACT 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 June 2, 2000 after a review of 28 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.

View all Selfcare, Inc. devices

FDA 510(k) Submission Details - K001427

510(k) Number K001427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2000
Decision Date June 02, 2000
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 273
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K001427.
GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM
K002624 · Apex BioTechnology Corp. · Jan 2001
SATURN BLOOD GLUCOSE MONITORING TEST STRIP
K001441 · Lifescan, Inc. · Dec 2000
CAMIT DIABETES MANAGEMENT SOFTWARE
K001907 · Roche Diagnostics Corp. · Sep 2000
ACCU-CHEK ADVANTAGE METER
K000365 · Roche Diagnostics Corp. · Feb 2000
AVL OPTI CRITICAL CARE ANALYZER
K993837 · Avl Scientific Corp. · Dec 1999
PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM
K992988 · Home Diagnostics, Inc. · Sep 1999