← Product Code [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX) · K961510 # ACS FRT4 IMMUNOASSAY (K961510) _Ciba Corning Diagnostics Corp. · JJX · Jun 17, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K961510 ## Device Facts - **Applicant:** Ciba Corning Diagnostics Corp. - **Product Code:** [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX.md) - **Decision Date:** Jun 17, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1660 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use For the quantitative determination of free thyroxine (FT4) in serum using the Ciba Corning Automated Chemiluminescence Systems. ## Device Story Competitive chemiluminescence immunoassay; measures free thyroxine (FT4) in serum samples. FT4 competes with acridinium ester-labeled T4 for polyclonal rabbit anti-T4 antibody coupled to paramagnetic particles. Indirect relationship between FT4 concentration and relative light units (RLUs). Used in clinical laboratory settings with Ciba Corning Automated Chemiluminescence Systems. Output provides quantitative FT4 levels to assist clinicians in evaluating thyroid status. ## Clinical Evidence Bench testing only. Correlation study (n=74) against RIA reference method showed r=0.97, equation: ACS FrT4 = 1.06(RIA) - 0.33. Sensitivity: 0.1 ng/dl (range up to 11.0 ng/dl). Precision: Total % CV 2.81-4.65%. ## Technological Characteristics Competitive chemiluminescence immunoassay. Solid phase: paramagnetic particles with covalently coupled polyclonal rabbit anti-T4 antibody. Tracer: acridinium ester-labeled T4. Analyte: free thyroxine (FT4). Platform: Ciba Corning Automated Chemiluminescence Systems. ## Regulatory Identification A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls. ## Predicate Devices - Amerlex-MAB FT4 (510(k) number not known) ## 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} Company Confidential K961510 JUN 17 1996 # Summary of Safety and Effectiveness As required by 21 CFR 807.92, the following 510(k) Summary is provided: ## 1. Submitter Information Contact person: Thomas F. Flynn Address: Ciba Corning Diagnostics Corp. 63 North Street Medfield, MA 02052 Phone: 508 359-3877 e-mail: thomas.flynn@cibadiag.com Date Summary Prepared: April 19. 1996 ## 2. Device Information Proprietary Name: ACS FrT4 Immunoassay Common Name: FrT4 Immunoassay Classification Name: Class II, Free Thyroxine Test Kit, 21 CFR 862.1695 ![img-0.jpeg](img-0.jpeg) ## 3. Predicate Device Information Name: Amerlex-MAB FT4 Manufacturer: Amerlex 510(k) Number: Not Known ## 4. Device Description The Ciba Corning ASC FrT4 Immunoassay is a competitive immunoassay. FT4 in the sample competes with the acridinium ester (AE-labeled T4 (Lite Reagent) for a limited amount of polyclonal rabbit anti-T4 antibody, which is covalently coupled to paramagnetic particles (solid phase). An indirect relationship exists between the FT4 in a sample and the relative light units (RLUs) detected. ## 5. Statement of Intended Use For the quantitative determination of free thyroxine (FT4) in serum using the Ciba Corning Automated Chemiluminescence Systems. ## 6. Summary of Technological Characteristics The Ciba Corning ACS FrT4 procedure is a competitive chemiluminescence immunoassay. ACS FrT4 510(k) Notification April 19, 1996 2 {1} Company Confidential # 7. Performance Data ## Sensitivity The ACS FrT4 immunoassay measures FT4 concentrations up to 11.0 ng/dl with a minimum detectable concentration of 0.1 ng/dl. ## Accuracy For 74 samples in the range of 0.62 to 4.26 ng/dl, the correlation between the ACS FrT4 immunoassay and the RIA reference method assay is described by the equation: $$ \text{ACS FrT4} = 1.06 \, (\text{RIA}) - 0.33 $$ Correlation coefficient (r) = 0.97 ## Precision Total precision (Total % CV) ranged from 2.81 to 4.65. ACS FrT4 510(k) Notification April 19, 1996 3 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K961510](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K961510) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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