Cleared Traditional

K964212 - QUINIDINE ENZYME IMMUNOASSAY

K964212 is the FDA 510(k) clearance for QUINIDINE ENZYME IMMUNOASSAY by Diagnostic Reagents, Inc.. It is a Class 2 Toxicology device (product code LBZ) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K964212 · Diagnostic Reagents, Inc. · Toxicology device
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Dec 1996
Decision
57d
Days
Class 2
Risk

K964212 is an FDA 510(k) clearance for the QUINIDINE ENZYME IMMUNOASSAY. Classified as Enzyme Immunoassay, Quinidine (product code LBZ), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 18, 1996 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - the FDA toxicology 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: 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 Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K964212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1996
Decision Date December 18, 1996
Days to Decision 57 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 87d · This submission: 57d
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 Toxicology devices follow this clearance model.

Regulatory Peers - LBZ Enzyme Immunoassay, Quinidine

All 21
Devices cleared under the same product code (LBZ) and FDA review panel - the closest regulatory comparables to K964212.
ROCHE ONLINE TDM QUINIDINE
K032332 · Roche Diagnostics Corp. · Jan 2004
QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964116 · Bayer Corp. · Dec 1996
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