K962118 · Diagnostic Systems Laboratories, Inc. · CGJ · Sep 9, 1996 · Clinical Chemistry
Device Facts
Record ID
K962118
Device Name
DSL ACTIVE FSH IRMA
Applicant
Diagnostic Systems Laboratories, Inc.
Product Code
CGJ · Clinical Chemistry
Decision Date
Sep 9, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1300
Device Class
Class 1
Indications for Use
The DSL FSH IRMA assay is intended for the quantitative determination of FSH in human serum. The measurement of FSH is used as a diagnostic aid in the diagnosis and treatment of pituitary gland and gonadal disorders.
Device Story
DSL 4700 FSH IRMA kit; non-competitive immunoradiometric assay (IRMA) for quantitative FSH measurement in human serum. Principle: analyte sandwiched between immobilized antibody on test tube wall and radiolabelled detection antibody. Process: sample incubation; decanting/washing to remove unbound material; gamma counter analysis of bound counts per minute. Output: FSH concentration directly proportional to bound counts. Used in clinical laboratory settings by trained technicians. Results assist physicians in diagnosing/treating pituitary and gonadal disorders.
Clinical Evidence
Bench testing only. Comparative study of 81 patient serum samples using DSL 4700 FSH IRMA and DPC FSH IMMULITE. Linear regression analysis: Y = 0.66(X) + 1.26; r = 0.98.
Technological Characteristics
Non-competitive immunoradiometric assay (IRMA). Components: test tubes with immobilized antibody, radiolabelled detection antibody. Detection via gamma counter. Quantitative measurement based on sandwich complex formation.
Indications for Use
Indicated for quantitative determination of FSH in human serum as a diagnostic aid for pituitary gland and gonadal disorders in patients requiring FSH level assessment.
Regulatory Classification
Identification
A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.
Predicate Devices
DPC FSH IMMULITE
Submission Summary (Full Text)
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Dl
SEP - 9 1996
K962118
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 4700 FSH IRMA Kit
Classification Name: Immunoradiometric Assay, FSH
Analyte Code and Name: Follicle Stimulating Hormone
Regulatory Class: I
Submitter: John Willis
Diagnostic Systems Laboratories, Inc.
445 Medical Center Boulevard
Webster, Texas 77598
Phone: 713-332-9678
Date: May 29, 1996
The DSL FSH IRMA kit was developed for the quantitative measurement of FSH 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 FSH is directly proportional to the concentration of the FSH present in the sample.
The DSL FSH IRMA assay is intended for the quantitative determination of FSH in human serum. The measurement of FSH is used as a diagnostic aid in the diagnosis and treatment of pituitary gland and gonadal disorders.
The DSL FSH IRMA is substantially equivalent to the DPC FSH IMMULITE.
To demonstrate substantial equivalence between the two assays, patient samples (n=81) were collected and assayed using both methods. Samples were chosen based on expected FSH 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 $Y = 0.66(X) + 1.26$ with a correlation coefficient of $(r) = 0.98$.
