← Product Code [CDP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP) · K960913 # ACCESS FREE T3 ASSAY (K960913) _Bio-Rad Laboratories, Inc. · CDP · Mar 29, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K960913 ## Device Facts - **Applicant:** Bio-Rad Laboratories, Inc. - **Product Code:** [CDP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP.md) - **Decision Date:** Mar 29, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1710 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The ACCESS® Free T3 assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum using the ACCESS® Immunoassay System. The Access® Free T3 assay aids in the diagnosis of hyperthyroidism. ## Device Story ACCESS® Free T3 assay is a paramagnetic particle chemiluminescent immunoassay used with the ACCESS® Immunoassay Analyzer for quantitative determination of free triiodothyronine in human serum. Device operates as a two-step competitive binding immunoenzymatic assay. Input: human serum sample. Process: polyclonal capture antibody binds to paramagnetic particles; chemiluminescent reaction produces light measured by analyzer. Output: quantitative free T3 concentration. Used in clinical laboratory settings by trained personnel. Results aid clinicians in diagnosing hyperthyroidism by providing objective T3 levels. ## Clinical Evidence Bench testing only. Precision studies: within-run CV 3.74%-12.75%; total imprecision CV 5.08%-13.42%. Correlation study: 217 samples compared against predicate (r=0.929, y=-1.09+1.33x). Analytical sensitivity: 0.30 pg/ml (95% confidence). ## Technological Characteristics Paramagnetic particle chemiluminescent immunoassay. Two-step competitive binding immunoenzymatic assay. Dioxetane-based chemiluminescent substrate. Polyclonal capture antibody. System includes ACCESS® Immunoassay Analyzer. Non-isotopic. ## 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 - Magic® 1-Free T3 Radioimmunoassay (Ciba Corning Diagnostics Corporation) ## 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} SANOFI DIAGNOSTICS PASTEUR, INC. 1000 LAKE HAZELTINE DRIVE CHASKA, MINNESOTA 55318-1084 U.S.A. TEL: (612) 448-4848 s anofi DIAGNOSTICS Pasteur K960913 # APPENDIX D - Summary of Safety and Effectiveness Information ## 1. General Information Device Generic Name: Enzyme Immunoassay, Free T3 Device Trade Name: ACCESS® Free T3 assay Applicant's Name and Address: Sanofi Diagnostics Pasteur, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 (612) 448 - 4848 Contact: Katia Breslawec MAR 29 1996 ## 2. Predicate Device Magic® 1-Free T3 Radioimmunoassay Ciba Coming Diagnostics Corporation 63 North Street Medfield, MA 02052 ## 3. Device Description The ACCESS® Free T3 reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of free triiodothyronine in human serum. ## 4. Indications for Use The ACCESS® Free T3 assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum using the ACCESS® Immunoassay System. The Access® Free T3 assay aids in the diagnosis of hyperthyroidism. ## 5. Comparison of Technological Characteristics The ACCESS® Free T3 assay and the Ciba Corning Magic® 1-Free T3 assay are intended for the measurement of free triiodothyronine in human serum. The ACCESS® Free T3 assay and the Ciba Corning Magic® 1-Free T3 assay use multi-point calibrators/standards prepared in human serum. The ACCESS® Free T3 assay is non isotopic and uses a dioxetane based chemiluminescent substrate, while the Ciba Corning Magic® 1-Free T3 assay is a radioimmunoassay utilizing $^{125}\mathrm{I}$ labeled triiodothyronine. The ACCESS® Free T3 assay measures light production from a chemiluminescent reaction, while the Ciba Corning Magic® 1-Free T3 assay measures radioactivity. The ACCESS® Free T3 assay binds polyclonal capture antibody to paramagnetic particles, while the Ciba Corning Magic® 1-Free T3 assay binds polyclonal anti-T3 to microparticles. The ACCESS® Free T3 assay is a two step competitive binding immunoenzymatic assay, while the Ciba Corning Magic® 1-Free T3 assay is a one step competitive immunoassay. ## 6. Summary of Studies **Precision studies:** Within run precision ranges from $3.74\%$ CV (high control) to $12.75\%$ CV (low control). Total imprecision ranges from $5.08\%$ CV (high control) to $13.42\%$ CV (low control). **Correlation:** A comparison of Free T3 values from 217 samples run in both the ACCESS® Free T3 assay and the Ciba Corning Magic® 1-Free T3 assay test gives the following statistical data: $r = 0.929$, $y = -1.09 + 1.33x$. **Analytical Sensitivity:** The lowest detectable level of Free T3 distinguishable from zero (Free T3 Calibrator S0) with $95\%$ confidence is $0.30~\mathrm{pg / ml}$. ## 7. Conclusion The ACCESS® Free T3 reagents when used with the ACCESS® Immunoassay Analyzer are substantially equivalent to another test for the measurement of Free T3 currently in commercial distribution. Kalestad Geretic Systens DAGONISTICS PASTEUR 20 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K960913](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K960913) **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