DSL ACTIVE I-HCG IRMA

K960357 · Diagnostic Systems Laboratories, Inc. · JHI · May 7, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960357
• Device Name: DSL ACTIVE I-HCG IRMA
• Applicant: Diagnostic Systems Laboratories, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: May 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The DSL I-hCG IRMA 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 8300 I-hCG IRMA kit; non-competitive immunoradiometric assay (IRMA) for quantitative hCG measurement in human serum. Principle: 'sandwich' immunoassay using two antibodies; one immobilized on test tube wall, one radiolabeled for detection. Procedure: sample incubation; decanting/washing to remove unbound material; gamma counter analysis of bound counts per minute. Output: hCG concentration directly proportional to bound counts. Used in clinical laboratories by professional personnel. Results aid clinicians in pregnancy detection.

Clinical Evidence

Bench testing only. Comparative study of 53 patient serum samples analyzed by both DSL 8300 I-hCG IRMA and predicate DPC hCG IRMA. Results showed strong correlation (r=0.96) with linear regression equation Y = 0.86(X) + 9.5.

Technological Characteristics

Non-competitive immunoradiometric assay (IRMA). Components: antibody-coated test tubes, radiolabeled antibody reagent. Detection via gamma counter. In vitro diagnostic use.

Indications for Use

Indicated for the quantitative measurement of human chorionic gonadotropin (hCG) in human serum to aid in the detection of pregnancy in clinical laboratory settings.

Regulatory Classification

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

• DPC hCG IRMA

Submission Summary (Full Text)

{0}

K960357
MAY - 7 1996
Diagnostic Systems Laboratories, Inc.
445 Medical Center Boulevard
Webster, Texas 77598-4217
Tel [phone]
Fax [phone]
Customer Assistance Center
Tel [phone]
Fax [phone]

# SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Device: DSL 8300 I-hCG IRMA Kit
Classification Name: Radioimmunoassay, 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: [phone]

Date: January 24, 1996

The DSL I-hCG IRMA kit was developed for the quantitative measurement of I-hCG in human serum. The IRMA 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 test tube, the other antibody is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed by decanting and washing the tubes. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of bound hCG is directly proportional to the concentration of the hCG present in the sample.

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

To demonstrate substantial equivalence between the two assays, patient samples (n=53) 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 $Y = 0.86(X) + 9.5$ with a correlation coefficient of (r) = 0.96.