Cleared Special

K000365 - ACCU-CHEK ADVANTAGE METER

K000365 is the FDA 510(k) clearance for ACCU-CHEK ADVANTAGE METER by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code CGA) cleared through the Special 510(k) pathway after a 19-day FDA review.

K000365 · Roche Diagnostics Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Feb 2000
Decision
19d
Days
Class 2
Risk

K000365 is an FDA 510(k) clearance for the ACCU-CHEK ADVANTAGE METER. Classified as Glucose Oxidase, Glucose (product code CGA), 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.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K000365 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.

Device Classification

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 Chemistry devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 127
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K000365.
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
K010520 · Instrumentation Laboratory CO · May 2001
RANDOX GLUCOSE (GOD/PAP)
K003346 · Randox Laboratories, Ltd. · Mar 2001
CAMIT DIABETES MANAGEMENT SOFTWARE
K001907 · Roche Diagnostics Corp. · Sep 2000
GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS
K990649 · Bayer Corp. · Jul 1999
GLUCOMETER ELITE TEST STRIPS
K991242 · Bayer Corp. · Jun 1999
DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL
K983344 · Dade Behring, Inc. · Jun 1999