DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)

K970701 · Diagnostic Systems Laboratories, Inc. · CFL · Apr 2, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970701
• Device Name: DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)
• Applicant: Diagnostic Systems Laboratories, Inc.
• Product Code: CFL · Clinical Chemistry
• Decision Date: Apr 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1370
• Device Class: Class 1

Indications for Use

The DSL hGH IRMA assay is intended for the quantitative determination of hGH in human serum. The measurement of hGH is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly.

Device Story

DSL 1900 hGH IRMA kit; non-competitive immunoradiometric assay (IRMA) for quantitative hGH measurement in human serum. Analyte sandwiched between immobilized antibody (coated tube) and radiolabelled antibody; unbound material removed via decanting/washing. Gamma counter measures net counts; bound hGH concentration directly proportional to counts. Used in clinical laboratory settings by trained personnel. Results aid clinicians in evaluating hGH deficiency or acromegaly.

Clinical Evidence

Bench testing only. Comparative study of 68 human serum samples using subject IRMA kit and predicate ELISA. Linear regression analysis: Y = 0.93(predicate) - 0.19; r = 0.97.

Technological Characteristics

Non-competitive immunoradiometric assay (IRMA). Components: antibody-coated tubes, radiolabelled antibody. Detection via gamma counter. Quantitative measurement based on direct proportionality between bound hGH and net counts.

Indications for Use

Indicated for quantitative measurement of hGH in human serum to aid in diagnosis of hGH deficiency disorders or acromegaly.

Regulatory Classification

Identification

A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.

Predicate Devices

• DSL 10-1900 hGH ELISA

Submission Summary (Full Text)

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K970701

Diagnostic Systems Laboratories, Inc.

445 Medical Center Boulevard

Webster Texas 77598-4217 USA

Tel [phone]

Fax [phone]

Customer Assistance Center

Tel [phone]

Fax [phone]

Email [e-mail]

APR - 2 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Device: DSL 1900 hGH IRMA Kit

Classification Name: Immunoradiometric Assay for hGH

Analyte Code and Name: hGH

Regulatory Class: I

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

Date: February 25, 1997

The DSL hGH IRMA kit was developed for the quantitative measurement of hGH 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 coated 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 tube. The resultant is analyzed in a gamma counter for net counts. The amount of bound hGH is directly proportional to the concentration of the hGH present in the sample.

The DSL hGH IRMA assay is intended for the quantitative determination of hGH in human serum. The measurement of hGH is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly.

The DSL 1900 hGH IRMA is substantially equivalent to the DSL 10-1900 hGH ELISA.

To demonstrate substantial equivalence between the two assays, human serum samples (n=68) were collected and assayed using both methods. Samples were chosen based on expected hGH 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 $Y = 0.93$ (DSL 10-1900) - 0.19 with a correlation coefficient of (r) = 0.97.