ACTIVE LH IRMA

K961109 · Diagnostic Systems Laboratories, Inc. · CEP · Apr 5, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961109
• Device Name: ACTIVE LH IRMA
• Applicant: Diagnostic Systems Laboratories, Inc.
• Product Code: CEP · Clinical Chemistry
• Decision Date: Apr 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1485
• Device Class: Class 1

Intended Use

The DSL LH IRMA assay is intended for the quantitative determination of LH in human serum. The measurement of LH is used as a diagnostic aid in the diagnosis and treatment of gonadal dysfunction.

Device Story

Immunoradiometric assay (IRMA) for quantitative measurement of LH in human serum; non-competitive sandwich format. Input: human serum sample. Process: analyte binds to immobilized antibody on test tube wall and radiolabelled detection antibody; unbound material removed via decanting/washing; radioactivity measured in gamma counter. Output: counts per minute directly proportional to LH concentration. Used in clinical laboratory settings by trained technicians. Results assist physicians in diagnosing and treating gonadal dysfunction.

Clinical Evidence

Bench testing only. Comparative study of 41 patient serum samples using subject device and predicate. Linear regression analysis: Y = 1.71(X) + 3.81; correlation coefficient r = 0.95.

Technological Characteristics

Immunoradiometric assay (IRMA) format; non-competitive sandwich technique. Components: test tubes with immobilized antibody, radiolabelled detection antibody. Detection via gamma counter. Quantitative measurement based on radioactivity proportional to analyte concentration.

Indications for Use

Indicated for quantitative determination of Luteinizing Hormone (LH) in human serum as a diagnostic aid for gonadal dysfunction.

Regulatory Classification

Identification

A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.

Predicate Devices

• DPC LH IRMA

Submission Summary (Full Text)

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K 961109

APR - 5 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Device: DSL 4600 LH IRMA Kit
Classification Name: Immunoradiometric Assay, LH
Analyte Code and Name: Luteinizing Hormone
Regulatory Class: I

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

Date: March 19, 1996

The DSL LH IRMA kit was developed for the quantitative measurement of LH 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 LH is directly proportional to the concentration of the LH present in the sample.

The DSL LH IRMA assay is intended for the quantitative determination of LH in human serum. The measurement of LH is used as a diagnostic aid in the diagnosis and treatment of gonadal dysfunction.

The DSL LH IRMA is substantially equivalent to the DPC LH IRMA.

To demonstrate substantial equivalence between the two assays, patient samples (n=41) were collected and assayed using both methods. Samples were chosen based on expected LH 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 $Y = 1.71(X) + 3.81$ with a correlation coefficient of $(r) = 0.95$.