Cleared Traditional

K955568 - INNOFLUOR QUINIDINE ASSAY SYSTEM

K955568 is an FDA 510(k) clearance for INNOFLUOR QUINIDINE ASSAY SYSTEM, manufactured by Oxis Intl., Inc.. The device is a Class 2 Toxicology device with product code LBZ cleared through the Traditional 510(k) pathway after a 120-day FDA review.

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

FDA 510(k) Submission Details - K955568

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
Combination Product No
PCCP Authorized No
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.

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 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.
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
K011605 · Syva Co., Dade Behring, Inc. · Jun 2001
QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964116 · Bayer Corp. · Dec 1996
QUINIDINE ENZYME IMMUNOASSAY
K964212 · Diagnostic Reagents, Inc. · 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