Cleared Traditional

K994433 - CONNECT DATA MANAGEMENT SYSTEM

K994433 is an FDA 510(k) clearance for CONNECT DATA MANAGEMENT SYSTEM, manufactured by Abbott Diabetes Care, Inc.. The device is a Class 2 Chemistry device with product code LFR cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K994433 · Abbott Diabetes Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
127d
Days
Class 2
Risk

K994433 is an FDA 510(k) clearance for the CONNECT DATA MANAGEMENT SYSTEM. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Abbott Diabetes Care, Inc. (Alameda, US). The FDA issued a Cleared decision on May 5, 2000 after a review of 127 days - within the typical 510(k) review window.

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 Abbott Diabetes Care, Inc. devices

FDA 510(k) Submission Details - K994433

510(k) Number K994433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1999
Decision Date May 05, 2000
Days to Decision 127 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
39d slower than avg
Panel avg: 88d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFR Device Classification - Class 2, Special Controls

Product Code LFR Glucose Dehydrogenase, 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 - LFR Glucose Dehydrogenase, Glucose

All 55
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K994433.
ACCU-CHEK COMFORT CURVE TEST STRIP
K010362 · Roche Diagnostics Corp. · Mar 2001
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
K000582 · Abbott Diabetes Care, Inc. · Dec 2000
SOF-TACT DIABETES MANAGEMENT SYSTEM
K001993 · Abbott Laboratories · Nov 2000
ACCU-CHEK COMPLETE METER
K000364 · Roche Diagnostics Corp. · Feb 2000
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
K992684 · Abbott Diabetes Care, Inc. · Jan 2000
ACCU-CHEK SIMPLICITY SYSTEM
K993829 · Roche Diagnostics Corp. · Dec 1999