Cleared Traditional

K851639 - ANTI-LEU-12 B CELL REAGENT (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K851639 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Jul 1986
Decision
439d
Days
Class 2
Risk

K851639 is an FDA 510(k) clearance for the ANTI-LEU-12 B CELL REAGENT. Classified as Assay, B Lymphocyte Marker (product code LJD), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on July 2, 1986 after a review of 439 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 K851639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1985
Decision Date July 02, 1986
Days to Decision 439 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
326d slower than avg
Panel avg: 113d · This submission: 439d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJD Assay, B Lymphocyte Marker
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.