← Product Code [JHI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI) · K961911

# DSL ACTIVE I-HCG ELISA (K961911)

_Diagnostic Systems Laboratories, Inc. · JHI · Jun 28, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI/K961911

## Device Facts

- **Applicant:** Diagnostic Systems Laboratories, Inc.
- **Product Code:** [JHI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI.md)
- **Decision Date:** Jun 28, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1155
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The DSL I-hCG ELISA assay is intended for the quantitative determination of I-hCG in human serum. It is intended for in vitro diagnostic use by professional laboratory personnel as an aid in the detection of pregnancy.

## Device Story

DSL 10-8300 I-hCG ELISA kit; quantitative measurement of hCG in human serum. Non-competitive sandwich ELISA format; analyte captured between immobilized antibody on microtitration well wall and horseradish peroxidase-conjugated antibody. Unbound materials removed via washing; spectrophotometer measures absorbance. Absorbance directly proportional to hCG concentration. Used in clinical laboratory settings by professional personnel. Output aids clinicians in pregnancy detection.

## Clinical Evidence

Bench testing only. Comparative study of 54 patient serum samples using DSL I-hCG ELISA and DSL I-hCG IRMA. Samples spanned low, intermediate, and high hCG concentrations. Linear regression analysis showed correlation coefficient r = 0.98.

## Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA). Non-competitive sandwich format. Components: microtitration wells with immobilized antibody, horseradish peroxidase-conjugated antibody. Detection via spectrophotometry. In vitro diagnostic kit.

## Regulatory Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

## Predicate Devices

- DSL I-hCG IRMA

## Submission Summary (Full Text)

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Diagnostic Systems Laboratories, Inc.
445 Medical Center Boulevard
Webster, Texas 77598-4217 US
Tel 713.332.9677
Fax 713.554.4277
Customer Assistance Center
Tel 800.231.797
Fax 713.338.189

# SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Device: DSL 10-8300 I-hCG ELISA Kit
Classification Name: Enzymeimmunoassay, Human Chorionic Gonadotropin
Analyte Code and Name: Human Chorionic Gonadotropin
Regulatory Class: II

Submitter: John Willis
Diagnostic Systems Laboratories, Inc.
445 Medical Center Boulevard
Webster, Texas 77598
Phone: 713-332-9678

Date: May 15, 1996

The DSL I-hCG ELISA kit was developed for the quantitative measurement of I-hCG in human serum. The ELISA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the inside wall of the microtitration well, the other antibody is conjugated to the enzyme horseradish peroxidase for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed by washing the wells. The resultant is analyzed in a spectrophotometer for absorbance. The amount of bound hCG is directly proportional to the concentration of the hCG present in the sample.

The DSL I-hCG ELISA assay is intended for the quantitative determination of I-hCG in human serum. It is intended for in vitro diagnostic use by professional laboratory personnel as an aid in the detection of pregnancy.

The DSL I-hCG ELISA is substantially equivalent to the DSL I-hCG IRMA.

To demonstrate substantial equivalence between the two assays, patient samples (n=54) were collected and assayed using both methods. Samples were chosen based on expected hCG 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 $Y = 0.92(X) + 16.5$ 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/JHI/K961911](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI/K961911)

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