AXSYM VANCOMYCIN II

K955851 · Abbott Laboratories · LEH · May 9, 1996 · Clinical Toxicology

Device Facts

• Record ID: K955851
• Device Name: AXSYM VANCOMYCIN II
• Applicant: Abbott Laboratories
• Product Code: LEH · Clinical Toxicology
• Decision Date: May 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3950
• Device Class: Class 2

Intended Use

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

Device Story

Automated fluorescence polarization immunoassay (FPIA) for quantitative vancomycin measurement in human serum or plasma; utilizes Abbott AxSYM system; reagents, calibrators, and controls used for clinical monitoring; provides quantitative results to healthcare providers for therapeutic drug management.

Clinical Evidence

Bench testing only; correlation study comparing AxSYM Vancomycin II to predicate (n=217) yielded slope 1.03, y-intercept -1.08, correlation coefficient 0.99, standard error 2.74.

Technological Characteristics

Automated fluorescence polarization immunoassay (FPIA); reagents, calibrators, and controls prepared gravimetrically; real-time stability testing performed.

Indications for Use

Indicated for quantitative determination of vancomycin in human serum or plasma for clinical monitoring.

Regulatory Classification

Identification

A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Predicate Devices

• AxSYM Vancomycin assay

Submission Summary (Full Text)

{0}

K955851

510(k) Summary

Abbott AxSYM® Vancomycin II

MAY - 9 1996

Summary of Safety and Effectiveness Information Supporting a Substantial Equivalent Determination

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

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

Slope: 1.03

Y-Intercept: -1.08

Correlation Coefficient: 0.99

Std. Error of the Y estimate: 2.74

Number: 217

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