K962758 · Diagnostic Systems Laboratories, Inc. · CFL · Aug 30, 1996 · Clinical Chemistry
Device Facts
Record ID
K962758
Device Name
DSL 9100 IGF-II IRMA
Applicant
Diagnostic Systems Laboratories, Inc.
Product Code
CFL · Clinical Chemistry
Decision Date
Aug 30, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1370
Device Class
Class 1
Indications for Use
The DSL IGF-II IRMA assay is intended for the quantitative determination of IGF-II in human serum or plasma. The measurement of IGF-II is used For In Vitro Diagnostic Use in the evaluation of growth status.
Device Story
Non-competitive immunoradiometric assay (IRMA) for quantitative measurement of IGF-II in human serum/plasma; utilizes sandwich complex formation between immobilized goat anti-IGF-II antibody and radiolabeled mouse monoclonal anti-IGF-II antibody; unbound materials removed via decanting/washing; bound complex measured via gamma counter; signal intensity directly proportional to IGF-II concentration; used in clinical laboratory settings for growth status evaluation; aids clinicians in assessing patient growth patterns.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Immunoradiometric assay (IRMA); non-competitive sandwich format; goat anti-IGF-II antibody immobilized on test tube walls; radiolabeled mouse monoclonal anti-IGF-II antibody for detection; gamma counter for signal quantification.
Indications for Use
Indicated for quantitative determination of IGF-II in human serum or plasma for evaluation of growth status.
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 IGF-I IRMA
Submission Summary (Full Text)
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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 9100 IGF-II IRMA Kit
Classification Name: Immunoradiometric Assay, IGF-II
Analyte Code and Name: Insulin Like Growth Factor-II
Regulatory Class: I
Submitter: John Willis
Diagnostic Systems Laboratories, Inc.
445 Medical Center Boulevard
Webster, Texas 77598
Phone: 713-332-9678
Date: July 12, 1996
The DSL IGF-II IRMA kit was developed for the quantitative measurement of IGF-II in human serum or plasma. The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody, goat anti-IGF-II, is immobilized to the inside wall of the test tube, the other antibody, mouse monoclonal anti-IGF-II 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 IGF-II is directly proportional to the concentration of the IGF-II present in the sample.
The DSL IGF-II IRMA assay is intended for the quantitative determination of IGF-II in human serum or plasma. The measurement of IGF-II is used For In Vitro Diagnostic Use in the evaluation of growth status.
The DSL IGF-II IRMA is substantially equivalent to the DSL IGF-I IRMA.
Both assays are used in the evaluation of growth status with human serum or plasma samples.
