← Product Code [CFL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL) · K960551 # DSL ACTIVE HUMAN GROWTH HORMONE ELISA (K960551) _Diagnostic Systems Laboratories, Inc. · CFL · Mar 6, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL/K960551 ## Device Facts - **Applicant:** Diagnostic Systems Laboratories, Inc. - **Product Code:** [CFL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL.md) - **Decision Date:** Mar 6, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1370 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use The DSL Active hGH ELISA Kit was developed for the quantitative measurement of human growth hormone in human serum. The measurement of growth hormone in serum is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly. ## Device Story DSL 10-1900 hGH ELISA Kit; quantitative measurement of human growth hormone in human serum. Principle: sandwich enzyme-linked immunosorbent assay (ELISA). Mouse monoclonal capture antibody immobilized on microtiter plate wells; serum sample or standard added; anti-hGH monoclonal antibody conjugated to horseradish peroxidase (HRP) added. Enzyme activity measured to determine hGH concentration. Used in clinical laboratory settings by trained personnel. Output: quantitative hGH concentration. Clinical utility: diagnostic aid for hGH deficiency or acromegaly. ## Clinical Evidence Method comparison study; 41 patient samples; samples spanned low, medium, and high hGH levels. Comparison between DSL hGH ELISA and Nichols Institute hGH IRMA. Results: linear regression Y = 1.06x + 0.25; correlation coefficient r = 0.99. ## Technological Characteristics Sandwich ELISA; mouse monoclonal capture antibody; HRP-conjugated monoclonal detection antibody; microtiter plate format. Quantitative measurement via enzymatic reaction. ## 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 - Nichols Institute hGH 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} D K960551 Diagnostic Systems Laboratories, Inc. 145 Medical Center Boulevard Webster, Texas 77598 121/18 Tel 713.332.9678 Fax 713.554.4320 Customer Assistance Center Tel 800.231.797 Fax 713.338.1896 # SUMMARY OF SAFETY AND EFFECTIVENESS Name of Device: DSL 10-1900 hGH ELISA Kit. Classification Name: Enzyme-Linked Immunosorbent Assay, hGH. Analyte Name: Human Growth Hormone. Regulatory Class: I Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Blvd. Webster, Texas 77598 Phone: (713) 332-9678 Date: February 7, 1996 The DSL Active hGH ELISA Kit was developed for the quantitative measurement of human growth hormone in human serum. Mouse monoclonal antibody "capture antibody" is immobilized to the inner surface of microtiter plate wells. Growth hormone in the standards or serum samples is "sandwiched" between the capture antibody and the anti-hGH monoclonal antibody conjugated to horseradish peroxidase enzyme. The measurement of growth hormone in serum is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly. The DSL hGH ELISA is substantially equivalent to the Nichols Institute hGH IRMA. These kits have the same intended use. To demonstrate substantial equivalence between the two assays, 41 patient samples were collected and assayed simultaneously by both methods. Samples were chosen with low medium and high levels of hGH. Linear regression analysis of the results obtained for the comparison yield the following results: $Y = 1.06x + 0.25$ with a correlation coefficient of 0.99. ![img-0.jpeg](img-0.jpeg) --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL/K960551](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFL/K960551) **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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