DSL ESTRONE-SULFATE RIA

K970915 · Diagnostic Systems Laboratories, Inc. · CGF · May 16, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970915
• Device Name: DSL ESTRONE-SULFATE RIA
• Applicant: Diagnostic Systems Laboratories, Inc.
• Product Code: CGF · Clinical Chemistry
• Decision Date: May 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1280
• Device Class: Class 1

Intended Use

The DSL 5400 Estrone-Sulfate RIA assay is intended for the quantitative determination of Estrone-Sulfate in human serum or EDTA plasma. The measurement of Estrone-Sulfate is used for in vitro diagnostic use in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, differentiation of primary and secondary ovarian malfunction, especially estrogen secreting testicular and ovarian tumors and precocious puberty in females.

Device Story

DSL 5400 Estrone-Sulfate RIA kit; competitive binding protein assay; measures Estrone-Sulfate in human serum/EDTA plasma. Input: patient sample; radio-labeled Estrone-Sulfate competes with sample Estrone-Sulfate for antiserum binding sites. Separation: second antibody (goat anti-rabbit gamma globulin) with polyethylene glycol; centrifugation; decantation. Output: bound counts per minute via gamma counter; concentration inversely proportional to bound counts. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing/treating infertility, amenorrhea, ovarian/testicular tumors, and precocious puberty.

Clinical Evidence

Bench testing only. Comparative study of 43 patient samples using DSL 5400 and DSL 8700 RIA methods. Linear regression analysis: Y=0.04(X) + 2.89; correlation coefficient r=0.82.

Technological Characteristics

Competitive binding radioimmunoassay (RIA). Reagents: Estrone-Sulfate antiserum, radio-labeled Estrone-Sulfate, second antibody (goat anti-rabbit gamma globulin), polyethylene glycol precipitating aid. Analysis via gamma counter. In vitro diagnostic use.

Indications for Use

Indicated for quantitative measurement of Estrone-Sulfate in human serum or EDTA plasma for diagnosis and treatment of infertility, amenorrhea, ovarian malfunction, estrogen-secreting tumors, and precocious puberty in females.

Regulatory Classification

Identification

An estrone test system is a device intended to measure estrone, an estrogenic steroid, in plasma. Estrone measurements are used in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, differentiation of primary and secondary ovarian malfunction, estrogen secreting testicular and ovarian tumors, and precocious puberty in females.

Predicate Devices

• DSL 8700 Estrone RIA

Submission Summary (Full Text)

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K970915 MAY 16 1997

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 5400 Estrone-Sulfate RIA Kit
Classification Name: Radioimmunoassay, Estrone-Sulfate
Analyte Code and Name: Estrone-Sulfate
Regulatory Class: I

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

Date: March 11, 1997

The DSL 5400 Estrone-Sulfate RIA kit was developed for the quantitative measurement of Estrone-Sulfate in human serum or EDTA plasma. The RIA format is a competitive binding protein assay. Radio-labeled Estrone-Sulfate competes with un-labeled Estrone-Sulfate in the serum or plasma sample for binding sites to the Estrone-Sulfate antiserum provided with the kit. Separation of free from bound Estrone-Sulfate is achieved by the addition of a second antibody containing goat anti-rabbit gamma globulin serum with polyethylene glycol as a precipitating aid, centrifugation and decantation of the tubes. The resultant is analyzed in a gamma counter for bound counts per minute. The amount of radio-labeled Estrone-Sulfate bound to the antibody is inversely proportional to the concentration of the Estrone-Sulfate present in the sample.

The DSL 5400 Estrone-Sulfate RIA assay is intended for the quantitative determination of Estrone-Sulfate in human serum or EDTA plasma. The measurement of Estrone-Sulfate is used for in vitro diagnostic use in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, differentiation of primary and secondary ovarian malfunction, especially estrogen secreting testicular and ovarian tumors and precocious puberty in females.

The DSL 5400 Estrone-Sulfate RIA is substantially equivalent to the DSL 8700 Estrone RIA. Both kits have the same intended use.

To demonstrate substantial equivalence between the two assays, patient samples (n=43) were collected and assayed using both methods. Samples were chosen based on expected Estrone-Sulfate 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 $Y=0.04(X) + 2.89$ with a correlation coefficient of $(r) = 0.82$.