← Product Code [CGJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ) · K962118 # DSL ACTIVE FSH IRMA (K962118) _Diagnostic Systems Laboratories, Inc. · CGJ · Sep 9, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K962118 ## Device Facts - **Applicant:** Diagnostic Systems Laboratories, Inc. - **Product Code:** [CGJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ.md) - **Decision Date:** Sep 9, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1300 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use The DSL FSH IRMA assay is intended for the quantitative determination of FSH in human serum. The measurement of FSH is used as a diagnostic aid in the diagnosis and treatment of pituitary gland and gonadal disorders. ## Device Story DSL 4700 FSH IRMA kit; non-competitive immunoradiometric assay (IRMA) for quantitative FSH measurement in human serum. Principle: analyte sandwiched between immobilized antibody on test tube wall and radiolabelled detection antibody. Process: sample incubation; decanting/washing to remove unbound material; gamma counter analysis of bound counts per minute. Output: FSH concentration directly proportional to bound counts. Used in clinical laboratory settings by trained technicians. Results assist physicians in diagnosing/treating pituitary and gonadal disorders. ## Clinical Evidence Bench testing only. Comparative study of 81 patient serum samples using DSL 4700 FSH IRMA and DPC FSH IMMULITE. Linear regression analysis: Y = 0.66(X) + 1.26; r = 0.98. ## Technological Characteristics Non-competitive immunoradiometric assay (IRMA). Components: test tubes with immobilized antibody, radiolabelled detection antibody. Detection via gamma counter. Quantitative measurement based on sandwich complex formation. ## Regulatory Identification A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders. ## Predicate Devices - DPC FSH IMMULITE ## 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} Dl SEP - 9 1996 K962118 Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster Texas 77598-4217 USA Tel 713.332.9678 Fax 713.554.4220 Customer Assistance Center Tel 800.231.7970 Fax 713.338.1895 # SUMMARY OF SAFETY AND EFFECTIVENESS Name of Device: DSL 4700 FSH IRMA Kit Classification Name: Immunoradiometric Assay, FSH Analyte Code and Name: Follicle Stimulating Hormone Regulatory Class: I Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: 713-332-9678 Date: May 29, 1996 The DSL FSH IRMA kit was developed for the quantitative measurement of FSH in human serum. The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the inside wall of the test tube, the other antibody 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 FSH is directly proportional to the concentration of the FSH present in the sample. The DSL FSH IRMA assay is intended for the quantitative determination of FSH in human serum. The measurement of FSH is used as a diagnostic aid in the diagnosis and treatment of pituitary gland and gonadal disorders. The DSL FSH IRMA is substantially equivalent to the DPC FSH IMMULITE. To demonstrate substantial equivalence between the two assays, patient samples (n=81) were collected and assayed using both methods. Samples were chosen based on expected FSH levels so that samples with low, intermediate and high levels would be evaluated. Linear regression analysis of the results obtained for the comparison gave the equation $Y = 0.66(X) + 1.26$ with a correlation coefficient of $(r) = 0.98$. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K962118](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGJ/K962118) **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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