Cleared Traditional

K912386 - REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165 (FDA 510(k) Clearance)

Class I Chemistry device.

K912386 · Helena Laboratories · Chemistry device
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Jul 1991
Decision
82d
Days
Class 1
Risk

K912386 is an FDA 510(k) clearance for the REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165. Classified as Electrophoretic, Protein Fractionation (product code CEF), Class I - General Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on July 17, 1991 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1630 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Helena Laboratories devices

Submission Details

510(k) Number K912386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1991
Decision Date July 17, 1991
Days to Decision 82 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
6d faster than avg
Panel avg: 88d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEF Electrophoretic, Protein Fractionation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1630
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.