Cleared Traditional

AVIE A1C TEST SYSTEM (K081269) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081269 · Mec Dynamics Corp · Chemistry device
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Mar 2009
Decision
319d
Days
Class 2
Risk

K081269 is an FDA 510(k) clearance for the AVIE A1C TEST SYSTEM. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Mec Dynamics Corp (Santa Clara, US). The FDA issued a Cleared decision on March 20, 2009 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - 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. Elevated predicate reliance profile. 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 Mec Dynamics Corp devices

Submission Details

510(k) Number K081269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2008
Decision Date March 20, 2009
Days to Decision 319 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
231d slower than avg
Panel avg: 88d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
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 - LCP Assay, Glycosylated Hemoglobin

All 248
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K081269.
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PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
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K183230 · Drawbridge Health, Inc. · Aug 2019