Cleared Special

K993632 - FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

K993632 is an FDA 510(k) clearance for FASTTAKE COMPACT BLOOD GLUCOSE MONITORI..., manufactured by Selfcare, Inc.. The device is a Class 2 Immunology device with product code CGA cleared through the Special 510(k) pathway after a 16-day FDA review.

K993632 · Selfcare, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
16d
Days
Class 2
Risk

K993632 is an FDA 510(k) clearance for the 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 November 12, 1999 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1345 - the FDA immunology device 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 - K993632

510(k) Number K993632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1999
Decision Date November 12, 1999
Days to Decision 16 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 105d · This submission: 16d
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 Immunology 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 K993632.
ACCU-CHEK ADVANTAGE METER
K000365 · Roche Diagnostics Corp. · Feb 2000
AVL OPTI CRITICAL CARE ANALYZER
K993837 · Avl Scientific Corp. · Dec 1999
HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]
K993128 · Health Hero Network, Inc. · Nov 1999
PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM
K992988 · Home Diagnostics, Inc. · Sep 1999
EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP
K991480 · Selfcare, Inc. · Sep 1999
GO GLUCOSE MONITORING SYSTEM
K991754 · Lxn Corp. · Sep 1999
K993632 · FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
Download PDF FDA Summary Selfcare, Inc.