← Product Code [CFL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL) · K961172 # DSL ACTIVE NON-EXTRACTION IGF-I IRMA (K961172) _Diagnostic Systems Laboratories, Inc. · CFL · Apr 23, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL/K961172 ## Device Facts - **Applicant:** Diagnostic Systems Laboratories, Inc. - **Product Code:** [CFL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL.md) - **Decision Date:** Apr 23, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1370 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use The DSL IGF-I IRMA assay is intended for the quantitative determination of IGF-I in human serum or EDTA plasma. The measurement of serum/plasma IGF-I is used as a diagnostic aid in the evaluation of growth status disorders. ## Device Story DSL 2800 IGF-I IRMA kit; immunoradiometric capture assay. Input: human serum or EDTA plasma samples. Principle: IGF-I analyte captured between immobilized mouse monoclonal antibody on test tube surface and Iodine-125 labeled goat-anti-IGF-I polyclonal antibody. Output: quantitative IGF-I concentration. Used in clinical laboratory settings by trained technicians. Results assist clinicians in diagnosing and monitoring growth status disorders. ## Clinical Evidence Bench-only study comparing subject device to predicate (DSL 5600). Sample size n=146 patient samples covering low, intermediate, and high IGF-I levels. Linear regression analysis: Y = 1.19(X) - 22.07; correlation coefficient (r) = 0.98. ## Technological Characteristics Immunoradiometric assay (IRMA) format. Capture mechanism: mouse monoclonal antibody immobilized on test tube surface; detection via Iodine-125 labeled goat-anti-IGF-I polyclonal antibody. Analyte: Insulin-like Growth Factor-I. ## Regulatory 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 5600 IGF-I IRMA ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K96/172 APR 22 1996 # SUMMARY OF SAFETY AND EFFECTIVENESS Name of Device: DSL 2800 IGF-I IRMA Kit Classification Name: Immunoradiometric, IGF-I Analyte Name: Insulin-like Growth Factor-I Regulatory Class: Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: 713-332-9678 Date: March 22, 1996 The DSL Active IGF-I IRMA kit was developed for the quantitative measurement of Insulin-like Growth Factor-I in human serum and plasma. This IRMA format is a capture assay. Mouse monoclonal antibody to IGF-I is immobilized to the inner surface of the coated test tubes. IGF-I in the standards or samples is "sandwiched" between this monoclonal and the goat-anti-IGF-I polyclonal antibody labelled with Iodine-125. The DSL IGF-I IRMA assay is intended for the quantitative determination of IGF-I in human serum or EDTA plasma. The measurement of serum/plasma IGF-I is used as a diagnostic aid in the evaluation of growth status disorders. The DSL IGF-I IRMA is substantially equivalent to the DSL 5600 IGF-I IRMA. These kits have the same intended use. To demonstrate substantial equivalence between the two assays, patient samples (n=146) 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 $Y = 1.19(X) - 22.07$ with a correlation coefficient of $(r) = 0.98$. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL/K961172](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL/K961172) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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