Cleared Traditional

K830963 - QUINIDINE REAGENT TEST KIT

K830963 is an FDA 510(k) clearance for QUINIDINE REAGENT TEST KIT, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Chemistry device with product code LBZ cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K830963 · Beckman Instruments, Inc. · Chemistry device
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Jun 1983
Decision
94d
Days
Class 2
Risk

K830963 is an FDA 510(k) clearance for the QUINIDINE REAGENT TEST KIT. Classified as Enzyme Immunoassay, Quinidine (product code LBZ), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - 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.

View all Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K830963

510(k) Number K830963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1983
Decision Date June 30, 1983
Days to Decision 94 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
6d slower than avg
Panel avg: 88d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBZ Device Classification - Class 2, Special Controls

Product Code LBZ Enzyme Immunoassay, Quinidine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
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 - LBZ Enzyme Immunoassay, Quinidine

All 24
Devices cleared under the same product code (LBZ) and FDA review panel - the closest regulatory comparables to K830963.
QUINIDINE ANALYTICAL TEST PACK
K840596 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1984
QUINIDINE FLUORESCENT IMMUNOASSAY
K832493 · American Diagnostic Corp. · Sep 1983
EMIT CAD QUINIDINE ASSAY FOR USE W/
K832096 · Syva Co. · Aug 1983
EMIT QST QUINIDINE ASSAY
K831355 · Syva Co. · Jun 1983
TDX QUINIDINE
K822653 · Abbott Laboratories · Sep 1982
ADVANCE EMIT-CAD QUINIDINE ASSAY
K822588 · Syva Co. · Sep 1982