DSL DHEA-S-7

K962895 · Diagnostic Systems Laboratories, Inc. · JKC · Sep 10, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962895
• Device Name: DSL DHEA-S-7
• Applicant: Diagnostic Systems Laboratories, Inc.
• Product Code: JKC · Clinical Chemistry
• Decision Date: Sep 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1245
• Device Class: Class 1

Intended Use

The DSL C2700 DHEA-S-7 RIA assay is intended for the quantitative determination of DHEA-S in human serum. The measurement of DHEA-S is used for in vitro diagnostic use in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.

Device Story

Competitive binding radioimmunoassay (RIA) kit; measures DHEA-S in human serum. Input: serum sample; radio-labeled DHEA-S tracer; DHEA-S antiserum. Process: competitive binding between labeled and unlabeled DHEA-S for antibody sites; centrifugation and decantation for separation; gamma counter analysis of bound counts. Output: radioactivity counts inversely proportional to DHEA-S concentration. Used in clinical laboratories by technicians. Results assist physicians in diagnosing and monitoring adrenal carcinomas.

Clinical Evidence

Bench testing only. Comparative study of 418 patient serum samples using subject device and predicate. Linear regression analysis: Y = 0.76(X) + 36.2; correlation coefficient r = 0.98.

Technological Characteristics

Competitive binding radioimmunoassay. Analyte: DHEA-S. Separation method: centrifugation and decantation. Detection: gamma counter. Format: in vitro diagnostic kit.

Indications for Use

Indicated for quantitative measurement of DHEA-S in human serum to aid in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.

Regulatory Classification

Identification

A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.

Predicate Devices

• DSL 2700 DHEA-S RIA

Submission Summary (Full Text)

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SEP 10 1996
K962895
Diagnostic Systems Laboratories, Inc.
445 Medical Center Boulevard
Webster Texas 77598-4217 USA
Tel [phone]
Fax [phone]
Customer Assistance Center
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Fax [phone]

# SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Device: DSL C2700 DHEA-S-7 RIA Kit
Classification Name: Radioimmunoassay, DHEA-S
Analyte Code and Name: DHEA-S-7
Regulatory Class: I

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

Date: July 24, 1996

The DSL C2700 DHEA-S-7 RIA kit was developed for the quantitative measurement of DHEA-S in human serum. The RIA format is a competitive binding protein assay. Radio-labeled DHEA-S competes with un-labeled DHEA-S in the serum sample for binding sites to the DHEA-S antiserum provided with the kit. Separation of free from bound DHEA-S is achieved by the centrifugation and decantation of the tubes. The resultant is analyzed in a gamma counter for bound counts per minute. The amount of radio-labeled DHEA-S bound to the antibody is inversely proportional to the concentration of the DHEA-S present in the sample.

The DSL C2700 DHEA-S-7 RIA assay is intended for the quantitative determination of DHEA-S in human serum. The measurement of DHEA-S is used for in vitro diagnostic use in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.

The DSL C2700 DHEA-S-7 RIA is substantially equivalent to the DSL 2700 DHEA-S RIA. Both kits have the same intended use.

To demonstrate substantial equivalence between the two assays, patient samples (n=418) were collected and assayed using both methods. Samples were chosen based on expected DHEA-S 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 $Y = 0.76(X) + 36.2$ with a correlation coefficient of $(r) = 0.98$.