Cleared Traditional

INNOFLUOR QUINIDINE ASSAY SYSTEM (K955568) - FDA 510(k) Clearance

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

K955568 · Oxis Intl., Inc. · Toxicology device
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Apr 1996
Decision
120d
Days
Class 2
Risk

K955568 is an FDA 510(k) clearance for the INNOFLUOR QUINIDINE ASSAY SYSTEM. Classified as Enzyme Immunoassay, Quinidine (product code LBZ), Class II - Special Controls.

Submitted by Oxis Intl., Inc. (Portland, US). The FDA issued a Cleared decision on April 4, 1996 after a review of 120 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Oxis Intl., Inc. devices

Submission Details

510(k) Number K955568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1995
Decision Date April 04, 1996
Days to Decision 120 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 87d · This submission: 120d
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 26
Devices cleared under the same product code (LBZ) and FDA review panel - the closest regulatory comparables to K955568.
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