AXSYM N-ACETYLPROCAINAMIDE

K955422 · Abbott Laboratories · LAN · Apr 24, 1996 · Clinical Toxicology

Device Facts

• Record ID: K955422
• Device Name: AXSYM N-ACETYLPROCAINAMIDE
• Applicant: Abbott Laboratories
• Product Code: LAN · Clinical Toxicology
• Decision Date: Apr 24, 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 N-acetylprocainamide in human serum or plasma (sodium heparin, tripotassium EDTA, potassium oxalate, and sodium citrate).

Device Story

Automated fluorescence polarization immunoassay (FPIA) for quantitative measurement of N-acetylprocainamide in human serum or plasma; used on AxSYM system; intended for clinical laboratory use; provides concentration data to clinicians for therapeutic drug monitoring; calibrators and controls used for system verification; performance validated via correlation with predicate TDx/TDxFLx assay.

Clinical Evidence

Correlation study comparing AxSYM N-Acetylprocainamide to predicate TDx/TDxFLx assay; n=205 samples; results: slope 1.05, y-intercept -0.1, correlation coefficient 0.993, standard error of Y estimate 0.081.

Technological Characteristics

Automated fluorescence polarization immunoassay (FPIA); utilizes Abbott AxSYM system; reagents, calibrators, and controls prepared gravimetrically; real-time stability testing for expiration dating.

Indications for Use

Indicated for the quantitative determination of N-acetylprocainamide in human serum or plasma to monitor therapeutic drug levels.

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 N-Acetylprocainamide assay

Submission Summary (Full Text)

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K955422

APR 24 1996

510(k) Summary

Abbott AxSYM N-Acetylprocainamide

Summary of Safety and Effectiveness Information Supporting a

Substantial Equivalent Determination

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

Substantial equivalence has been demonstrated between the AxSYM N-Acetylprocainamide assay and the TDx/TDxFLx N-Acetylprocainamide assay. Both assays are automated fluorescence polarization immunoassays (FPIA). The intended use of both assays is for the quantitative determination of N-acetylprocainamide 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: 1.05

Y-Intercept: -0.1

Correlation Coefficient: 0.993

Std. Error of the Y estimate: 0.081

Number: 205

The AxSYM N-Acetylprocainamide standard calibrators and controls are to be used with the AxSYM N-Acetylprocainamide 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 N-Acetylprocainamide 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