Cleared Traditional

K911731 - LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR (FDA 510(k) Clearance)

Class I Hematology device.

K911731 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
608d
Days
Class 1
Risk

K911731 is an FDA 510(k) clearance for the LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR. Classified as Lymphocyte Separation Medium (product code JCF), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on December 15, 1992 after a review of 608 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K911731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1991
Decision Date December 15, 1992
Days to Decision 608 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
495d slower than avg
Panel avg: 113d · This submission: 608d
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.