← Product Code [CDP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP) · K960550 # ACTIVE T3 RIA (K960550) _Diagnostic Systems Laboratories, Inc. · CDP · Mar 6, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K960550 ## Device Facts - **Applicant:** Diagnostic Systems Laboratories, Inc. - **Product Code:** [CDP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP.md) - **Decision Date:** Mar 6, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1710 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The DSL ACTIVE™ T3 RIA assay is intended for the quantitative determination of Total T3 in human serum. The measurement of T3 is used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism. ## Device Story Competitive binding protein radioimmunoassay (RIA) for quantitative measurement of Total T3 in human serum; radio-labeled T3 competes with serum T3 for antibody binding sites; coated tubes used for separation; decanting removes free T3; gamma counter measures bound counts per minute; inverse proportionality between bound radio-labeled T3 and sample T3 concentration; performed in clinical laboratory settings by trained technicians; results used by physicians to diagnose and manage thyroid disorders. ## Clinical Evidence Bench testing only. Comparison study using 30 patient samples with low, intermediate, and high T3 levels; linear regression analysis (Y=1.09(X)-8.8) and correlation coefficient (r=0.90) against predicate device. ## Technological Characteristics Competitive binding protein radioimmunoassay; utilizes radio-labeled T3 and antibody-coated tubes; requires gamma counter for signal detection; in vitro diagnostic kit format. ## Regulatory Identification A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism. ## Predicate Devices - DPC COAT-A-COUNT TOTAL T3 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} Dl K960550 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 3100 ACTIVE™ T3 RIA Kit Classification Name: Radioimmunoassay, Triiodothyronine Analyte Code and Name: Total Triiodothyronine Regulatory Class: II ![img-0.jpeg](img-0.jpeg) Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone:713-332-9678 Date: February 7, 1996 The DSL ACTIVE™ T3 RIA kit was developed for the quantitative measurement of Total T3 in human serum. The RIA format is a competitive binding protein assay. Radio-labeled T3 competes with un-labeled T3 in the serum sample for binding sites to the antibody. Separation of free from bound T3 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 T3 bound to the antibody is inversely proportional to the concentration of the T3 present in the sample. The DSL ACTIVE™ T3 RIA assay is intended for the quantitative determination of Total T3 in human serum. The measurement of T3 is used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism. The DSL ACTIVE™ T3 RIA is substantially equivalent to the DPC COAT-A-COUNT TOTAL T3 RIA. To demonstrate substantial equivalence between the two assays, patient samples (n=30) were collected and assayed using both methods. Samples were chosen based on expected T3 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 $Y = 1.09(X) + -8.8$ with a correlation coefficient of (r) = 0.90. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K960550](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K960550) **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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