Cleared Traditional

K854093 - LEUCO PREP (FDA 510(k) Clearance)

Class I Hematology device.

K854093 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Nov 1985
Decision
36d
Days
Class 1
Risk

K854093 is an FDA 510(k) clearance for the LEUCO PREP. Classified as Lymphocyte Separation Medium (product code JCF), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on November 12, 1985 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8500 - the FDA hematology device 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K854093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1985
Decision Date November 12, 1985
Days to Decision 36 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 113d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JCF Lymphocyte Separation Medium
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8500
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.