ACTIVE ANDROSTENEDIONE EIA

K963002 · Diagnostic Systems Laboratories, Inc. · CIZ · Aug 16, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963002
• Device Name: ACTIVE ANDROSTENEDIONE EIA
• Applicant: Diagnostic Systems Laboratories, Inc.
• Product Code: CIZ · Clinical Chemistry
• Decision Date: Aug 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1075
• Device Class: Class 1

Indications for Use

The DSL Androstenedione EIA assay is intended for the quantitative determination of androstenedione in human serum. The measurement of androstenedione is used in the diagnosis and treatment of females with excessive levels of androgen production.

Device Story

Competitive enzyme immunoassay (EIA) kit for quantitative measurement of androstenedione in human serum; utilizes microtitration wells coated with androstenedione antibody; enzyme-labeled androstenedione competes with sample androstenedione for antibody binding sites; separation achieved via aspiration and washing; bound enzyme-labeled androstenedione measured via spectrophotometry; absorbance inversely proportional to sample androstenedione concentration; used in clinical laboratory settings by trained personnel; results assist clinicians in diagnosing and managing hyperandrogenism in females.

Clinical Evidence

Method comparison study using 80 human serum samples; compared DSL 10-3800 EIA against DSL 3800 RIA; linear regression analysis resulted in Y=1.07(X)+0.02 with correlation coefficient r=0.85.

Technological Characteristics

Competitive binding protein assay; microtitration well format; antibody-coated wells; enzyme-labeled androstenedione reagent; spectrophotometric detection.

Indications for Use

Indicated for the quantitative measurement of androstenedione in human serum to aid in the diagnosis and treatment of females with excessive androgen production.

Regulatory Classification

Identification

An androstenedione test system is a device intended to measure androstenedione (a substance secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione measurements are used in the diagnosis and treatment of females with excessive levels of androgen (male sex hormone) production.

Predicate Devices

• DSL 3800 Androstenedione RIA

Submission Summary (Full Text)

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K963002

Diagnostic Systems Laboratories, Inc.
445 Medical Center Boulevard
Webster Texas 77598-4217 USA
Tel [phone]
Fax [phone]

Customer Assistance Center
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# SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Device: DSL 10-3800 Androstenedione EIA Kit
Classification Name: Enzymeimmunoassay, Androstenedione
Analyte Code and Name: Androstenedione
Regulatory Class: I

Submitter: John Willis
Diagnostic Systems Laboratories, Inc.
445 Medical Center Boulevard
Webster, Texas 77598
Phone: [phone]

Date: July 31, 1996

The DSL Androstenedione EIA kit was developed for the quantitative measurement of Androstenedione in human serum. The EIA format is a competitive binding protein assay. Enzyme-labeled androstenedione competes with un-labeled androstenedione in the serum sample for binding sites to the androstenedione antibody coated to the microtitration well provided with the kit. Separation of free from bound androstenedione is achieved by aspirating and washing the wells. The resultant is analyzed in a spectrophotometer for bound absorbance. The amount of enzyme-labeled androstenedione bound to the antibody is inversely proportional to the concentration of the androstenedione present in the sample.

The DSL Androstenedione EIA assay is intended for the quantitative determination of androstenedione in human serum. The measurement of androstenedione is used in the diagnosis and treatment of females with excessive levels of androgen production.

The DSL 10-3800 Androstenedione EIA is substantially equivalent to the DSL 3800 Androstenedione RIA. Both kits have the same intended use.

To demonstrate substantial equivalence between the two assays, patient samples (n=80) were collected and assayed using both methods. Samples were chosen based on expected Androstenedione levels so that samples with low, intermediate and high levels would be evaluated. Linear regression analysis of the results obtained for the comparison gave the equation $Y = 1.07(X) + 0.02$ with a correlation coefficient of (r) = 0.85.