Cleared Traditional

QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K964116) - FDA 510(k) Clearance

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

K964116 · Bayer Corp. · Chemistry device
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Dec 1996
Decision
70d
Days
Class 2
Risk

K964116 is an FDA 510(k) clearance for the QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM). Classified as Enzyme Immunoassay, Quinidine (product code LBZ), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on December 24, 1996 after a review of 70 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bayer Corp. devices

Submission Details

510(k) Number K964116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1996
Decision Date December 24, 1996
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 26
Devices cleared under the same product code (LBZ) and FDA review panel - the closest regulatory comparables to K964116.
ROCHE ONLINE TDM QUINIDINE
K032332 · Roche Diagnostics Corp. · Jan 2004
COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
K941440 · Roche Diagnostic Systems, Inc. · Jul 1994
EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
K922913 · Syva Co. · Aug 1992
EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS
K904990 · Syva Co. · Feb 1991
TDXR FLECAINIDE
K872175 · Abbott Laboratories · Aug 1987
EASY-TEST QUINIDINE ITEM NO. 67---/95
K864607 · Em Diagnostic Systems, Inc. · Jan 1987