DSL ACTIVE NON-EXTRACTION IGF-I ELISA

K971353 · Diagnostic Systems Laboratories, Inc. · CFL · May 12, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971353
• Device Name: DSL ACTIVE NON-EXTRACTION IGF-I ELISA
• Applicant: Diagnostic Systems Laboratories, Inc.
• Product Code: CFL · Clinical Chemistry
• Decision Date: May 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1370
• Device Class: Class 1

Intended Use

The DSL IGF-I ELISA assay is intended for the quantitative determination of IGF-1 in human serum. The measurement of serum IGF-I is used as a diagnostic aid in the evaluation of growth-related disorders.

Device Story

DSL 10-2800 IGF-I ELISA kit; enzyme-linked immunosorbent assay (ELISA) for quantitative measurement of Insulin-like Growth Factor-I (IGF-I) in human serum. Principle: capture assay; mouse monoclonal antibody to IGF-I immobilized on microtitration wells; IGF-I in samples sandwiched between immobilized antibody and horseradish peroxidase-conjugated anti-IGF-I antibody. Used in clinical laboratory settings by trained personnel. Output: quantitative IGF-I concentration. Clinical utility: diagnostic aid for growth-related disorders.

Clinical Evidence

Bench testing only. Comparative study of 319 patient samples using DSL 10-2800 ELISA and DSL 2800 IRIMA. Linear regression analysis: Y = 0.60(X) + 0.73; correlation coefficient r = 0.82.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) format. Components: microtitration wells coated with mouse monoclonal anti-IGF-I antibody; horseradish peroxidase-conjugated anti-IGF-I antibody. Detection via enzymatic reaction.

Indications for Use

Indicated for quantitative determination of IGF-1 in human serum as a diagnostic aid in evaluating growth-related disorders.

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 2800 IGF-I IRIMA

Submission Summary (Full Text)

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D. S. L USA

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Diganoslic System's laboratories, Inc. 445 Medic il ' Sen or Boulevard Wabster Texa . 77598-4217 1JSA Tel [phone] a: 281.554.4220

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## SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Device: Classification Name: Analyte Name: Regulatory Class:

DSL 10-2800 IGF-I ELISA Kit Enzyme Linked Immunosorbent Assay, IGF-I Insulin-like Growth Factor-l -

MAY 1 2 1997

- Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: [phone]
May 7, 1997 Date:

The DSL Active IGF-1 ELISA kit was developed for the quantitative measuremer t of Insulin-like Growth Factor-I in human serum. This ELISA format is a capture assay. Mouse monoclonal antibody to IGF-I is immobilized to the inner surface of the microtitration wells. IGF-I in the standards or samples is "sandwiched" between this monoclonal and the anti-IGF-I antibody conjugated to the enzyme horseradish peroxidase.

The DSL IGF-I ELISA assay is intended for the quantitative determination of IGF-1 in human serum. The measurement of serum IGF-I is used as a diagnostic aid in the evaluation of growth-related disorders.

The DSL 10-2800 IGF-I ELISA is substantially equivalent to the DSL 2800 IGF-I IRIMA. These kits have the same intended use.

To demonstrate substantial equivalence between the two assays, patient samples (n = 319) were collected and assayed simultaneously by both methods. Samples were chosen based on expected IGF-I levels so that samples with low, intermediate and high levels of IGF-I would be evaluated. Linear regression analysis of the results obtained for the comparison with the IGF-1 assay gave the equation Y =0.60(X) +0.73 with a correlation coefficient of (r) = 0.82.