Cleared Traditional

K043474 - ACCU-CHEK AVIVA SYSTEM

K043474 is an FDA 510(k) clearance for ACCU-CHEK AVIVA SYSTEM, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K043474

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.

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 56
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K043474.
THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
K070984 · Abbott Diabetes Care, Inc. · Nov 2007
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