← Product Code [JKC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC) · K962895

# DSL DHEA-S-7 (K962895)

_Diagnostic Systems Laboratories, Inc. · JKC · Sep 10, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K962895

## Device Facts

- **Applicant:** Diagnostic Systems Laboratories, Inc.
- **Product Code:** [JKC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC.md)
- **Decision Date:** Sep 10, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1245
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Indications for 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.

## Regulatory 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 713.332.9678
Fax 713.554.4220
Customer Assistance Center
Tel 800.231.7970
Fax 713.338.1895

# 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: 713-332-9678

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 $(r) = 0.98$.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K962895](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JKC/K962895)

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