Cleared Special

K993829 - ACCU-CHEK SIMPLICITY SYSTEM

K993829 is the FDA 510(k) clearance for ACCU-CHEK SIMPLICITY SYSTEM by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code LFR) cleared through the Special 510(k) pathway after a 27-day FDA review.

K993829 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
27d
Days
Class 2
Risk

K993829 is an FDA 510(k) clearance for the ACCU-CHEK SIMPLICITY SYSTEM. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 9, 1999 after a review of 27 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K993829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1999
Decision Date December 09, 1999
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K993829.
ACCU-CHEK COMFORT CURVE TEST STRIP
K010362 · Roche Diagnostics Corp. · Mar 2001
SOF-TACT DIABETES MANAGEMENT SYSTEM
K001993 · Abbott Laboratories · Nov 2000
ACCU-CHEK COMPLETE METER
K000364 · Roche Diagnostics Corp. · Feb 2000
ACCU-CHEK HQ SYSTEM
K983047 · Boehringer Mannheim Corp. · Feb 1999
ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS
K982089 · Boehringer Mannheim Corp. · Sep 1998
ACCU-CHEK COMFORT CURVE TEST STRIP
K982002 · Boehringer Mannheim Corp. · Sep 1998