DSL 9100 IGF-II IRMA

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

Intended 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 [phone]
Fax [phone]

Customer Assistance Center
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# 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: [phone]

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.