← Product Code [CGI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI) · K955356 # ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL (K955356) _Diagnostic Systems Laboratories, Inc. · CGI · May 15, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI/K955356 ## Device Facts - **Applicant:** Diagnostic Systems Laboratories, Inc. - **Product Code:** [CGI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI.md) - **Decision Date:** May 15, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1265 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA assay is intended for the quantitative determination of Unconjugated Estriol in human serum. The measurement of Unconjugated Estriol is used as a diagnostic aid in the diagnosis and treatment of fetoplacental distress. ## Device Story Radioimmunoassay (RIA) kit for quantitative measurement of Unconjugated Estriol in human serum; competitive binding protein assay format. Input: human serum sample. Mechanism: radio-labeled Unconjugated Estriol competes with unlabeled analyte for binding sites on antibody-coated tubes; separation via decanting; gamma counter measures bound counts per minute. Output: concentration of Unconjugated Estriol (inversely proportional to bound radio-labeled estriol). Used in clinical laboratory settings by trained technicians. Results assist clinicians in diagnosing and managing fetoplacental distress. ## Clinical Evidence Bench testing and clinical comparison study. 126 patient samples with low, intermediate, and high Unconjugated Estriol levels were assayed using both the subject device and the predicate. Linear regression analysis showed r = 0.97. ## Technological Characteristics Competitive binding protein radioimmunoassay. Components: antibody-coated tubes. Detection: gamma counter. Analyte: Unconjugated Estriol. ## Regulatory Identification An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy. ## Predicate Devices - DPC FREE ESTRIOL RIA ## 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} 1 55356 MAY 15 1996 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 3700 ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA Kit Classification Name: Radioimmunoassay, UNCONJUGATED ESTRIOL Analyte Code and Name: Unconjugated Estriol Regulatory Class: I Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: 713-332-9678 Date: March 6, 1996 The DSL Ultra-Sensitive Unconjugated Estriol RIA kit was developed for the quantitative measurement of Unconjugated Estriol in human serum. The RIA format is a competitive binding protein assay. Radio-labeled Unconjugated Estriol competes with un-labeled Unconjugated Estriol in the serum sample for binding sites on the antibody coated tubes. Separation of free from bound Unconjugated Estriol is achieved by decanting the coated tubes after incubation. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of radio-labeled estriol bound to the antibody is inversely proportional to the concentration of the estriol present in the sample. The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA assay is intended for the quantitative determination of Unconjugated Estriol in human serum. The measurement of Unconjugated Estriol is used as a diagnostic aid in the diagnosis and treatment of fetoplacental distress. The DSL ULTRA-SENSITIVE UNCONJUGATED ESTRIOL RIA is substantially equivalent to the DPC FREE ESTRIOL RIA. To demonstrate substantial equivalence between the two assays, patient samples (n = 126) were collected and assayed using both methods. Samples were chosen based on expected Unconjugated Estriol 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 $Y = 0.58(X) + -0.03$ with a correlation coefficient of $(r) = 0.97$. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI/K955356](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CGI/K955356) **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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