ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL

K955356 · Diagnostic Systems Laboratories, Inc. · CGI · May 15, 1996 · Clinical Chemistry

Device Facts

• Record ID: K955356
• Device Name: ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
• Applicant: Diagnostic Systems Laboratories, Inc.
• Product Code: CGI · Clinical Chemistry
• Decision Date: May 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1265
• Device Class: Class 1

Intended Use

The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA 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

Radioimmunoassay (RIA) kit for quantitative measurement of Unconjugated Estriol in human serum; competitive binding protein assay format. Input: human serum sample. Mechanism: radio-labeled Unconjugated Estriol competes with unlabeled analyte for binding sites on antibody-coated tubes; separation via decanting; gamma counter measures bound counts per minute. Output: concentration of Unconjugated Estriol (inversely proportional to bound radio-labeled estriol). Used in clinical laboratory settings by trained technicians. Results assist clinicians in diagnosing and managing fetoplacental distress.

Clinical Evidence

Bench testing and clinical comparison study. 126 patient samples with low, intermediate, and high Unconjugated Estriol levels were assayed using both the subject device and the predicate. Linear regression analysis showed r = 0.97.

Technological Characteristics

Competitive binding protein radioimmunoassay. Components: antibody-coated tubes. Detection: gamma counter. Analyte: Unconjugated Estriol.

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

• DPC FREE ESTRIOL RIA

Submission Summary (Full Text)

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1

55356

MAY 15 1996

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 3700 ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA Kit

Classification Name: Radioimmunoassay, 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: March 6, 1996

The DSL Ultra-Sensitive Unconjugated Estriol RIA kit was developed for the quantitative measurement of Unconjugated Estriol in human serum. The RIA format is a competitive binding protein assay. Radio-labeled Unconjugated Estriol competes with un-labeled Unconjugated Estriol in the serum sample for binding sites on the antibody coated tubes. Separation of free from bound Unconjugated Estriol is achieved by decanting the coated tubes after incubation. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of radio-labeled estriol bound to the antibody is inversely proportional to the concentration of the estriol present in the sample.

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

To demonstrate substantial equivalence between the two assays, patient samples (n = 126) 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 $Y = 0.58(X) + -0.03$ with a correlation coefficient of $(r) = 0.97$.