Cleared Traditional

K843062 - TBM-REAGENT FOR T,B CELL & MONOCYTES

K843062 is an FDA 510(k) clearance for TBM-REAGENT FOR T, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Microbiology device with product code LIZ cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K843062 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Optimized for regulatory review, auditing and printing
Apr 1985
Decision
243d
Days
Class 2
Risk

K843062 is an FDA 510(k) clearance for the TBM-REAGENT FOR T,B CELL & MONOCYTES. 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 April 3, 1985 after a review of 243 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.5220 - the FDA microbiology 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 Microbiology 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 - K843062

510(k) Number K843062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1984
Decision Date April 03, 1985
Days to Decision 243 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 102d · This submission: 243d
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 Microbiology 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 K843062.
TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD
K860830 · Technicon Instruments Corp. · Sep 1986
ANTI-LEU-4 FITC LYSIN C BUFFER
K842218 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1984
QUANTIGEN T & B CELL ASSAY
K831053 · Bio-Rad · Aug 1983
ORTHO SPECTRUM III & ORTHO-MUNE OK
K820643 · Ortho Diagnostic Systems, Inc. · Jul 1982