ABBOTT AXSM PROCAINAMIDE ASSAY

K955444 · Abbott Laboratories · LAR · Apr 2, 1996 · Clinical Toxicology

Device Facts

• Record ID: K955444
• Device Name: ABBOTT AXSM PROCAINAMIDE ASSAY
• Applicant: Abbott Laboratories
• Product Code: LAR · Clinical Toxicology
• Decision Date: Apr 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3320
• Device Class: Class 2

Intended Use

The intended use of both assays is for the quantitative determination of procainamide in human serum or plasma (sodium heparin, tripotassium EDTA, potassium oxalate, and sodium citrate).

Device Story

Automated fluorescence polarization immunoassay (FPIA) for quantitative procainamide measurement in human serum or plasma; used on AxSYM system; operated by laboratory personnel; provides numerical concentration values to clinicians for therapeutic drug monitoring; supports clinical decision-making regarding procainamide dosage.

Clinical Evidence

Bench testing only. Correlation study comparing AxSYM Procainamide to TDx/TDxFLx predicate (n=205) yielded slope 0.98, y-intercept 0.1, and correlation coefficient 0.989.

Technological Characteristics

Automated fluorescence polarization immunoassay (FPIA). Reagents, calibrators, and controls prepared gravimetrically. Real-time stability testing performed for expiration dating.

Indications for Use

Indicated for the quantitative determination of procainamide in human serum or plasma 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

• TDx/TDxFLx Procainamide assay

Submission Summary (Full Text)

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510(k) Summary

Abbott AxSYM Procainamide

Summary of Safety and Effectiveness Information Supporting a

Substantial Equivalent Determination

APR - 2 1996

The following information as presented in the Premarket Notification 510(k) for AxSYM Procainamide constitutes data supporting a substantially equivalent determination.

Substantial equivalence has been demonstrated between the AxSYM Procainamide assay and the TDx/TDxFLx Procainamide assay. Both assays are automated fluorescence polarization immunoassays (FPIA). The intended use of both assays is for the quantitative determination of procainamide in human serum or plasma (sodium heparin, tripotassium EDTA, potassium oxalate, and sodium citrate). Both assays are calibrated with Abbott calibrators. Abbott controls are assayed controls used for verification of the accuracy and precision of the AxSYM system. Correlation studies indicated the following results:

Slope: 0.98

Y-Intercept: 0.1

Correlation Coefficient: 0.989

Std. Error of the Y estimate: 0.056

Number: 205

The AxSYM Procainamide standard calibrators and controls are to be used with the AxSYM Procainamide reagents. The calibrators and controls are prepared gravimetrically using purified material obtained from commercial sources. The calibrators and controls are verified using protocols involving multiple instrument testing. AxSYM Procainamide reagent, calibrator and control expiration dates are based on real time stability testing.

Prepared and Submitted :

Grace LeMieux

[phone]

Abbott Laboratories

200 Abbott Park Road

Abbott Park, IL 60064-3537