Cleared Traditional

K842218 - ANTI-LEU-4 FITC LYSIN C BUFFER

K842218 is an FDA 510(k) clearance for ANTI-LEU-4 FITC LYSIN C BUFFER, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Hematology device with product code LIZ cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K842218 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Dec 1984
Decision
206d
Days
Class 2
Risk

K842218 is an FDA 510(k) clearance for the ANTI-LEU-4 FITC LYSIN C BUFFER. Classified as Assay, T Lymphocyte Surface Marker (product code LIZ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 27, 1984 after a review of 206 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K842218

510(k) Number K842218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1984
Decision Date December 27, 1984
Days to Decision 206 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 113d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIZ Device Classification - Class 2, Special Controls

Product Code LIZ Assay, T Lymphocyte Surface 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.

Regulatory Peers - LIZ Assay, T Lymphocyte Surface Marker

Devices cleared under the same product code (LIZ) and FDA review panel - the closest regulatory comparables to K842218.
TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD
K860830 · Technicon Instruments Corp. · Sep 1986
TBM-REAGENT FOR T,B CELL & MONOCYTES
K843062 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1985
QUANTIGEN T & B CELL ASSAY
K831053 · Bio-Rad · Aug 1983
ORTHO SPECTRUM III & ORTHO-MUNE OK
K820643 · Ortho Diagnostic Systems, Inc. · Jul 1982