← Product Code [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT) · K970389 # THYROID CALIBRATOR (K970389) _Dade Chemistry Systems, Inc. · JIT · Feb 18, 1997 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K970389 ## Device Facts - **Applicant:** Dade Chemistry Systems, Inc. - **Product Code:** [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT.md) - **Decision Date:** Feb 18, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1150 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The Thyroid Calibrator is intended to be used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to calibrate the FT4 and TSH methods. ## Device Story Liquid bovine albumin-based calibrator; contains thyroxine and human TSH (levels 2-5); level 1 contains no detectable thyroxine or TSH. Used on Dimension® RxL clinical chemistry system with heterogeneous immunoassay module. Provides reference points for calibrating FT4 and TSH assays. Used by laboratory personnel in clinical settings to ensure accuracy of patient thyroid hormone measurements. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Liquid bovine albumin matrix; 5-level kit; 2.0 mL per vial. Designed for use with Dimension® RxL clinical chemistry system. ## Regulatory Identification A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.) ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. ## Predicate Devices - aca® plus FT4 Calibrator - aca® plus TSH Calibrator ## 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} DADE FEB 18 1997 K970389 Interoffice Memorandum # Summary of Safety and Effectiveness Information This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Submitter's Name: Cathy P. Craft Dade International Inc. P.O. Box 6101 Newark, DE 19714-6101 Date of Preparation: 1/29/97 Name of Product: Thyroid Calibrator FDA Classification Name: Calibrator Predicate Device: aca® plus FT4 Calibrator and aca® plus TSH Calibrator Device Description: The Thyroid Calibrator is a liquid bovine albumin based product. The Level 1 calibrator contains no detectable thyroxine or TSH. Levels 2 through 5 contain thyroxine and human TSH. The kit consists of ten vials; two at each of five levels. Intended use: The Thyroid Calibrator is intended to be used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to calibrate the FT4 and TSH methods. 4 000005 {1} Comparison to Predicate Device: | Item | Thyroid Calibrator | aca® plus FT4 Calibrator | aca® plus TSH Calibrator | | --- | --- | --- | --- | | Intended Use | Calibrator | Calibrator | Calibrator | | Analytes | thyroxine, TSH | thyroxine | TSH | | Matrix | bovine albumin | human serum | horse serum | | Form | liquid | lyophilized | lyophilized | | Volume | 2.0 mL per vial | 3.0 mL per vial, reconstituted | 5.0 mL per vial, reconstituted | | Levels | 5 levels | 3 levels | 3 levels | Comments on Substantial Equivalence: Both the Thyroid Calibrator and the aca® plus FT4 Calibrator are intended to be used as calibrators for free thyroxine methods. Both the Thyroid Calibrator and the aca® plus TSH Calibrator are intended to be used as calibrators for thyroid stimulating hormone methods. Conclusion: The Thyroid Calibrator is substantially equivalent to the aca® plus FT4 Calibrator and the aca® plus TSH Calibrator for their respective analytes based on the comparison discussed above. ![img-0.jpeg](img-0.jpeg) Cathy P. Craft Regulatory Affairs and Compliance Manager Date: 1/29/97 000009 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K970389](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K970389) **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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