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
Indications for 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.
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 281.332.94.70 a: 281.554.4220
Customer Assistance Center
Tel 800.231.7970
Fax 281.338.1895
Email niktgi@dslabs.com
## 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: 281-332-9678
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.
