Cleared Traditional

K945519 - FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM (FDA 510(k) Clearance)

Class I Chemistry device.

K945519 · Pharmaquest Corp. · Chemistry device
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Nov 1995
Decision
359d
Days
Class 1
Risk

K945519 is an FDA 510(k) clearance for the FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE.... Classified as Urinary Carbohydrate Analysis Kit (product code MPG), Class I - General Controls.

Submitted by Pharmaquest Corp. (San Rafael, US). The FDA issued a Cleared decision on November 3, 1995 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1505 - 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.

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Submission Details

510(k) Number K945519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1994
Decision Date November 03, 1995
Days to Decision 359 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
271d slower than avg
Panel avg: 88d · This submission: 359d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MPG Urinary Carbohydrate Analysis Kit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1505
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.