ABBOTT AXSYM DIGITOXIN (MODIFY)

K963158 · Abbott Laboratories · LFM · Sep 10, 1996 · Clinical Toxicology

Device Facts

• Record ID: K963158
• Device Name: ABBOTT AXSYM DIGITOXIN (MODIFY)
• Applicant: Abbott Laboratories
• Product Code: LFM · Clinical Toxicology
• Decision Date: Sep 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3300
• Device Class: Class 2

Intended Use

The Abbott AxSYM Digitoxin assay is for the quantitative determination of digitoxin in human serum or plasma (sodium heparin and potassium oxalate).

Device Story

Automated fluorescence polarization immunoassay (FPIA) for quantitative digitoxin measurement in human serum or plasma; utilizes Abbott AxSYM system; calibrators and controls used for accuracy/precision verification; results used by clinicians to monitor therapeutic drug levels; provides quantitative output for clinical decision-making.

Clinical Evidence

Correlation study comparing AxSYM Digitoxin to predicate (TDx/TDxFLx). Sample size n=517. Results: slope 0.96, y-intercept 0.58, correlation coefficient 0.97, standard error of Y estimate 1.87.

Technological Characteristics

Automated fluorescence polarization immunoassay (FPIA). Uses Abbott AxSYM system instrumentation. Reagents, calibrators, and controls prepared gravimetrically from purified materials. Stability verified via real-time testing.

Indications for Use

Indicated for the quantitative measurement of digitoxin in human serum or plasma to assist in monitoring therapeutic drug levels.

Regulatory Classification

Identification

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

Predicate Devices

• TDx/TDxFLx Digitoxin assay

Submission Summary (Full Text)

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K963158

SEP 10 1996

510(k) Summary

Abbott AxSYM® Digitoxin

Summary of Safety and Effectiveness Information Supporting a

Substantial Equivalent Determination

The Abbott AxSYM Digitoxin assay is substantially equivalence to the TDx/TDxFLx Digitoxin assay. Both assays are automated fluorescence polarization immunoassays (FPIA). The intended use of both assays is for the quantitative determination of digitoxin in human serum or plasma (sodium heparin and potassium oxalate). Both assays are calibrated with Abbott calibrators. Abbott controls are used for verification of accuracy and precision of the AxSYM system when used for the quantitative determination of digitoxin in human serum or plasma. Correlation studies indicated the following results:

Slope: 0.96

Y-intercept: 0.58

Correlation Coefficient: 0.97

Std. Error of the Y estimate: 1.87

Number: 517

The AxSYM Digitoxin standard calibrators and controls are to be used with the AxSYM Digitoxin 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 Digitoxin 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