← Product Code [CDP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP) · K962355 # FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K962355) _Bayer Corp. · CDP · Jul 12, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K962355 ## Device Facts - **Applicant:** Bayer Corp. - **Product Code:** [CDP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP.md) - **Decision Date:** Jul 12, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1710 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use This in vitro method is intended to quantitatively measure Free T3 in human serum on a Technicon Immuno-1 system. Measurements of Free T3 are used in the diagnosis and treatment of thyroid diseases. ## Device Story The Immuno 1 Free T3 method is an in vitro diagnostic assay designed for use on the Technicon Immuno-1 system. It measures Free T3 concentrations in human serum samples. The device utilizes specific reagents and calibrators to perform the assay, providing quantitative results that assist clinicians in diagnosing and managing thyroid-related conditions. The system automates the measurement process, allowing for clinical laboratory use. Results are interpreted by healthcare providers to inform clinical decision-making regarding thyroid disease status and therapeutic monitoring. ## Clinical Evidence Bench testing only. Performance compared to predicate device using 103 serum samples. Correlation coefficient (r) = 0.94; regression equation y = 0.95x - 0.08. Precision (between-run) reported at three concentration levels (1.7, 5.4, 12.8 pg/mL) with CVs ranging from 2.7% to 8.2%. Minimum detectable concentration reported as 0.2 pg/mL. Specificity evaluated via cross-reactivity testing against 18 substances, including thyroid hormones and common medications. ## Technological Characteristics In vitro diagnostic immunoassay reagents and calibrators for use on the Technicon Immuno-1 system. Quantitative measurement of Free T3 in human serum. Specificity characterized by low cross-reactivity (<0.1% for most tested substances). ## 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 - INCSTAR Clinical Assays™ GammaCoat™ Free T3 RIA kit ## 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} JUL 12 1996 K962355 # SUMMARY OF SAFETY AND EFFECTIVENESS ## Free T3 Method for Bayer Technicon Immuno 1® System Listed below is a comparison of the performance between the Immuno 1 Free T3 method and a similar device that was granted clearance of substantial equivalence (INCSTAR Clinical Assays™ GammaCoat™ Free T3 RIA kit). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Free T3 method sheet and the Clinical Assays Free T3 Instruction Manual. ## INTENDED USED This *in vitro* method is intended to quantitatively measure Free T3 in human serum on a *Technicon Immuno-1* system. Measurements of Free T3 are used in the diagnosis and treatment of thyroid diseases. | METHOD | Immuno 1 Free T3 | | Clinical Assays (predicate Device) | | | --- | --- | --- | --- | --- | | Part No. | Reagents T01-3662-51 | | CA-1751 | | | | Calibrators T03-3663-01 | | | | | Minimum Detectable Conc. | 0.2 pg/mL | | 0.02 pg/mL | | | Precision (Between-Run) | 1.7 pg/mL | 8.2% | 2.2 pg/mL | 6.9% | | | 5.4 pg/mL | 4.1% | 8.3 pg/mL | 7.1% | | | 12.8 pg/mL | 2.7% | 15.8 pg/mL | 8.4% | | Correlation | y = 0.95x - 0.08 where | | | | | | y = Immuno 1 Free T3 method | | | | | | x = Clinical Assays Free T3 method | | | | | | n = 103 | | | | | | r = 0.94 | | | | | | S_{yx} = 0.71 pg/mL | | | | {1} # SPECIFICITY % Crossreactivity of : | | Immuno 1 Free T3 | Clinical Assays Free T3 | | --- | --- | --- | | Diiodo-L-tyrosine | <0.1 | <0.02 | | 3-Iodo-L-tyrosine | <0.1 | <0.02 | | Methimazole | 0.0 | N/R | | Phenylbutazone | <0.1 | <0.02 | | 6-n-Propyl-2-thyouracil | <0.1 | N/R | | Tetraiodothyro-acetic acid | <0.1 | N/R | | L-Thyroxine (T4) | <0.1 | <0.02 | | D-Thyroxine | <0.1 | <0.02 | | Ibuprofen | 0 | N/R | | Phenobarbital | 0 | N/R | | Phenytoin | 0 | N/R | | Acetaminophen | 0 | N/R | | 3,5 Diiodo-L-Thyronine | <0.1 | <0.02 | | Acetyl Salicylic Acid | <0.1 | N/R | | Heparinic Acid | <0.1 | N/R | | L-3,3’5’Triiodo-Thyronine | 0.34 | N/R | | Triiodothyroacetic acid | 0.37 | N/R | | Fenoprofen | <0.1 | N/R | N/R = Not Reported Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 7/3/96 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K962355](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K962355) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com