Cleared Traditional

K112790 - AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON (FDA 510(k) Clearance)

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

K112790 · Axis-Shield Diagnostics, Ltd. · Chemistry device
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May 2012
Decision
224d
Days
Class 2
Risk

K112790 is an FDA 510(k) clearance for the AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON. Classified as Urinary Homocystine (nonquantitative) Test System (product code LPS), Class II - Special Controls.

Submitted by Axis-Shield Diagnostics, Ltd. (Dundee, Scotland, GB). The FDA issued a Cleared decision on May 7, 2012 after a review of 224 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1377 - 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.

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Submission Details

510(k) Number K112790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2011
Decision Date May 07, 2012
Days to Decision 224 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
136d slower than avg
Panel avg: 88d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPS Urinary Homocystine (nonquantitative) Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1377
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.