ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA

K962875 · Diagnostic Systems Laboratories, Inc. · CGI · Aug 23, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962875
• Device Name: ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
• Applicant: Diagnostic Systems Laboratories, Inc.
• Product Code: CGI · Clinical Chemistry
• Decision Date: Aug 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1265
• Device Class: Class 1

Intended Use

The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL EIA assay is intended for the quantitative determination of Unconjugated Estriol in human serum. The measurement of Unconjugated Estriol is used as a diagnostic aid in the diagnosis and treatment of fetoplacental distress.

Device Story

Competitive binding enzyme immunoassay (EIA) for quantitative measurement of unconjugated estriol in human serum; utilizes horseradish peroxidase-labeled unconjugated estriol competing with sample estriol for antibody binding sites; substrate tetramethylbenzidine (TMB) added post-incubation/wash; enzymatic turnover measured via dual-wavelength absorbance; used in clinical laboratory settings by trained personnel; results aid clinicians in assessing fetoplacental status to guide management of pregnancy complications.

Clinical Evidence

Bench testing only. Comparative study of 106 patient serum samples using both the subject EIA kit and the predicate RIA method. Linear regression analysis showed r = 0.93, Y = 0.85(X) - 0.11.

Technological Characteristics

Competitive binding enzyme immunoassay (EIA); horseradish peroxidase label; tetramethylbenzidine (TMB) substrate; dual-wavelength absorbance detection; manual or automated plate reader format.

Indications for Use

Indicated for quantitative measurement of unconjugated estriol in human serum as a diagnostic aid in the diagnosis and treatment of fetoplacental distress.

Regulatory Classification

Identification

An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.

Predicate Devices

• DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA

Submission Summary (Full Text)

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AUG 23 1996
K962875

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

# SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Device: DSL 10-3700 ULTRA-SENSITIVE UNCONJUGATED ESTRIOL EIA Kit
Classification Name: Enzyme Immunoassay, UNCONJUGATED ESTRIOL
Analyte Code and Name: Unconjugated Estriol
Regulatory Class: I

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

Date: July 19, 1996

The DSL Ultra-Sensitive Unconjugated Estriol EIA kit was developed for the quantitative measurement of Unconjugated Estriol in human serum. The EIA format is a competitive binding protein assay. Horseradish peroxidase labelled unconjugated estriol competes with un-labeled Unconjugated Estriol in the serum sample for antibody binding sites. After incubation and washing the wells are incubated with the substrate tetramethylbenzidine (TMB). An acidic stopping solution is then added and the degree of enzymatic turnover of the substrate is determined by dual wavelength absorbance measurement.

The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL EIA assay is intended for the quantitative determination of Unconjugated Estriol in human serum. The measurement of Unconjugated Estriol is used as a diagnostic aid in the diagnosis and treatment of fetoplacental distress.

The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL EIA is substantially equivalent to the DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA.

To demonstrate substantial equivalence between the two assays, patient samples (n = 106) were collected and assayed using both methods. Samples were chosen based on expected Unconjugated Estriol 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 $Y = 0.85(X) - 0.11$ with a correlation coefficient of (r) = 0.93.