AXSYM PROGESTERONE

K955025 · Abbott Laboratories · JLS · Mar 7, 1996 · Clinical Chemistry

Device Facts

• Record ID: K955025
• Device Name: AXSYM PROGESTERONE
• Applicant: Abbott Laboratories
• Product Code: JLS · Clinical Chemistry
• Decision Date: Mar 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1620
• Device Class: Class 1

Intended Use

AxSYM Progesterone is a microparticle enzyme immunoassay for the quantitative determination of progesterone in human serum and plasma (heparin or EDTA).

Device Story

Microparticle enzyme immunoassay (MEIA) for quantitative progesterone measurement in human serum/plasma; utilizes Abbott AxSYM System instrumentation; calibrated with Abbott calibrators/controls; used in clinical laboratory settings by trained personnel; provides quantitative results to clinicians for assessment of progesterone levels; aids in clinical decision-making regarding reproductive health/endocrine status.

Clinical Evidence

Bench testing only. Correlation study performed on 209 clinical specimens comparing AxSYM Progesterone to predicate Coat-A-Count assay. Results: correlation coefficient 0.96, slope 0.86, standard error of Y-estimate 2.29, Y-axis intercept 0.77 ng/mL.

Technological Characteristics

Microparticle enzyme immunoassay (MEIA) technology; automated on AxSYM System; quantitative measurement; dynamic range 0-40 ng/mL.

Indications for Use

Indicated for the quantitative determination of progesterone in human serum or plasma.

Regulatory Classification

Identification

A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.

Predicate Devices

• Diagnostics Products Corporation Coat-A-Count® Progesterone assay

Submission Summary (Full Text)

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K955025

# 510(K) SUMMARY ABBOTT AxSYM PROGESTERONE

## SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING A SUBSTANTIALLY EQUIVALENT DETERMINATION

The following information as presented in the Premarket Notification for AxSYM® Progesterone constitutes data supporting a substantially equivalent determination.

AxSYM Progesterone is a microparticle enzyme immunoassay for the quantitative determination of progesterone in human serum and plasma (heparin or EDTA). AxSYM Progesterone is calibrated with Abbott calibrators and Abbott controls are used for verification of the calibration and to monitor the performance of the Abbott AxSYM System.

Substantial equivalence has been demonstrated between the Abbott AxSYM Progesterone assay and the Diagnostics Products Corporation Coat-A-Count® Progesterone assay. The intended use of both assays is for the quantitative determination of progesterone in human serum or plasma. A correlation analysis between these two assays, using 209 specimens, yielded a correlation coefficient of 0.96, slope of 0.86, standard error of Y-estimate of 2.29 and Y-axis intercept of 0.77 ng/mL. Both assays have a dynamic range of 0 - 40 ng/mL progesterone.

In conclusion, these data demonstrate that the AxSYM Progesterone assay is as safe and effective and is substantially equivalent to the Diagnostics Products Corporation Coat-A-Count Progesterone assay.

Prepared and Submitted October 31, 1995, by:

Abbott Laboratories
Joy C. Sonsalla
Senior Regulatory Specialist
ADD Regulatory Affairs
Abbott Park, IL 60064

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