Cleared Traditional

K043474 - ACCU-CHEK AVIVA SYSTEM

K043474 is the FDA 510(k) clearance for ACCU-CHEK AVIVA SYSTEM by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code LFR) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K043474 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
132d
Days
Class 2
Risk

K043474 is an FDA 510(k) clearance for the ACCU-CHEK AVIVA 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 April 27, 2005 after a review of 132 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K043474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2004
Decision Date April 27, 2005
Days to Decision 132 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
44d slower than avg
Panel avg: 88d · This submission: 132d
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 K043474.
FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM
K092688 · Taidoc Technology Corporation · Jul 2011
MODIFICATION TO ACCU-CHEK GO SYSTEM
K051592 · Roche Diagnostics Corp. · Sep 2005
ACCU-CHEK INTEGRA SYSTEM
K050872 · Roche Diagnostics Corp. · May 2005
ACCU-CHEK GO SYSTEM
K040796 · Roche Diagnostics Corp. · Apr 2004
ACCU-CHEK COMPACT TEST STRIP
K031755 · Roche Diagnostics Corp. · Jul 2003
MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING
K022941 · Abbott Laboratories · Oct 2002