Cleared Traditional

K142089 - ACCU-CHEK AVIVA EXPERT SYSTEM

K142089 is an FDA 510(k) clearance for ACCU-CHEK AVIVA EXPERT SYSTEM, manufactured by Roche Diagnostics Corporation. The device is a Class 2 Chemistry device with product code LFR cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K142089 · Roche Diagnostics Corporation · Chemistry device
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Dec 2014
Decision
138d
Days
Class 2
Risk

K142089 is an FDA 510(k) clearance for the ACCU-CHEK AVIVA EXPERT SYSTEM. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Roche Diagnostics Corporation (Indianapolis, US). The FDA issued a Cleared decision on December 17, 2014 after a review of 138 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 Corporation devices

FDA 510(k) Submission Details - K142089

510(k) Number K142089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2014
Decision Date December 17, 2014
Days to Decision 138 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
50d slower than avg
Panel avg: 88d · This submission: 138d
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 69
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