Cleared Traditional

SOF-TACT DIABETES MANAGEMENT SYSTEM (K001993) - FDA 510(k) Clearance

Also marketed or referenced as:
SOF-TACT GLUCOSE TEST STRIP PRECISION CONTROL SOLUTIONS

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K001993 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
137d
Days
Class 2
Risk

K001993 is an FDA 510(k) clearance for the SOF-TACT DIABETES MANAGEMENT SYSTEM. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Abbott Laboratories (Bedford, US). The FDA issued a Cleared decision on November 13, 2000 after a review of 137 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 Laboratories devices

Submission Details

510(k) Number K001993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2000
Decision Date November 13, 2000
Days to Decision 137 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
49d slower than avg
Panel avg: 88d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 32
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K001993.
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS
K004010 · Roche Diagnostics Corp. · Apr 2001
ACCU-CHEK INFORM METER
K003846 · Roche Diagnostics Corp. · Mar 2001
ACCU-CHEK COMFORT CURVE TEST STRIP
K010362 · Roche Diagnostics Corp. · Mar 2001
ACCU-CHEK COMPLETE METER
K000364 · Roche Diagnostics Corp. · Feb 2000
ACCU-CHEK SIMPLICITY SYSTEM
K993829 · Roche Diagnostics Corp. · Dec 1999
ACCU-CHEK HQ SYSTEM
K983047 · Boehringer Mannheim Corp. · Feb 1999