Cleared Traditional

K831053 - QUANTIGEN T & B CELL ASSAY

K831053 is the FDA 510(k) clearance for QUANTIGEN T & B CELL ASSAY by Bio-Rad. It is a Class 2 Chemistry device (product code LIZ) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K831053 · Bio-Rad · Chemistry device
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Aug 1983
Decision
129d
Days
Class 2
Risk

K831053 is an FDA 510(k) clearance for the QUANTIGEN T & B CELL ASSAY. Classified as Assay, T Lymphocyte Surface Marker (product code LIZ), Class II - Special Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on August 8, 1983 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.5220 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K831053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1983
Decision Date August 08, 1983
Days to Decision 129 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 88d · This submission: 129d
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 Chemistry 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 K831053.
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
ANTI-LEU-4 FITC LYSIN C BUFFER
K842218 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1984
ORTHO SPECTRUM III & ORTHO-MUNE OK
K820643 · Ortho Diagnostic Systems, Inc. · Jul 1982