Cleared Traditional

K843062 - TBM-REAGENT FOR T,B CELL & MONOCYTES (FDA 510(k) Clearance)

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

K843062 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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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

Submission Details

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
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.

Device Classification

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.