INNOFLUOR QUINIDINE ASSAY SYSTEM

K955568 · Oxis Intl., Inc. · LBZ · Apr 4, 1996 · Clinical Toxicology

Device Facts

• Record ID: K955568
• Device Name: INNOFLUOR QUINIDINE ASSAY SYSTEM
• Applicant: Oxis Intl., Inc.
• Product Code: LBZ · Clinical Toxicology
• Decision Date: Apr 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

The INNOFLUOR™ Quinidine Assay System (Modified) is intended for the quantitative measurement of quinidine in human serum.

Device Story

In vitro diagnostic assay; measures quinidine concentrations in human serum; performed on Abbott TDx® analyzer; used by laboratory personnel for therapeutic drug monitoring; results used by clinicians to assess patient quinidine levels; aids in optimizing dosage and managing toxicity.

Clinical Evidence

Bench testing only. Comparison of 49 serum patient samples between INNOFLUOR™ and Abbott Quinidine Assay. Linear regression: y = 0.958x - 0.077; correlation coefficient r = 0.986.

Technological Characteristics

In vitro diagnostic reagent system; quantitative assay; designed for use on Abbott TDx® analyzer; utilizes established immunoassay principles for quinidine detection.

Indications for Use

Indicated for quantitative measurement of quinidine in human serum for therapeutic drug monitoring.

Regulatory Classification

Identification

A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Predicate Devices

• INNOFLUOR™ Quinidine Reagent Set (Existing)
• Abbott Quinidine Assay

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS

Substantial equivalence has been demonstrated between the INNOFLUOR™ Quinidine Assay System (Modified) and the Abbott Quinidine Assay.

The technological characteristics, performance and intended use of the INNOFLUOR™ Quinidine Assay System (Modified) are substantially equivalent to the INNOFLUOR™ Quinidine Reagent Set (Existing) and the Abbott Quinidine Assay.

Quinidine concentrations measured by the INNOFLUOR™ QUINIDINE Assay System (Modified), (INNOFLUOR™), on the Abbott TDx® analyzer were compared with those measured by the Abbott Quinidine Assay, (Abbott), on 49 serum patient samples. Comparison of the patient sample results by linear regression analysis resulted in the regression equation: $$(INNOFLUOR™) = 0.958 \times (Abbott) - 0.077$$, with a correlation coefficient of 0.986.