Cleared Traditional

K962914 - REP 3 QUTO-FLUR CHOLESTEROL-30 (FDA 510(k) Clearance)

Class I Chemistry device.

K962914 · Helena Laboratories · Chemistry device
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Jan 1997
Decision
171d
Days
Class 1
Risk

K962914 is an FDA 510(k) clearance for the REP 3 QUTO-FLUR CHOLESTEROL-30. Classified as Electrophoretic Separation, Lipoproteins (product code JHO), Class I - General Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on January 13, 1997 after a review of 171 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 K962914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1996
Decision Date January 13, 1997
Days to Decision 171 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
83d slower than avg
Panel avg: 88d · This submission: 171d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JHO Electrophoretic Separation, Lipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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.