Cleared Special

K000364 - ACCU-CHEK COMPLETE METER

K000364 is an FDA 510(k) clearance for ACCU-CHEK COMPLETE METER, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code LFR cleared through the Special 510(k) pathway after a 19-day FDA review.

K000364 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
19d
Days
Class 2
Risk

K000364 is an FDA 510(k) clearance for the ACCU-CHEK COMPLETE METER. 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 February 23, 2000 after a review of 19 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.

FDA 510(k) Submission Details - K000364

510(k) Number K000364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2000
Decision Date February 23, 2000
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 71
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K000364.
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
CONNECT DATA MANAGEMENT SYSTEM
K994433 · Abbott Diabetes Care, Inc. · May 2000
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
K992684 · Abbott Diabetes Care, Inc. · Jan 2000
ACCU-CHEK SIMPLICITY SYSTEM
K993829 · Roche Diagnostics Corp. · Dec 1999
ACCU-CHEK HQ SYSTEM
K983047 · Boehringer Mannheim Corp. · Feb 1999
K000364 · ACCU-CHEK COMPLETE METER
Download PDF FDA Summary Roche Diagnostics Cor…