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.
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)
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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
(708) 937-0165
Abbott Laboratories
200 Abbott Park Road
Abbott Park, IL 60064-3537
