← Product Code [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX) · K962573 # ELECSYS PRECICONTROL TSH (K962573) _Boehringer Mannheim Corp. · JJX · Jul 22, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K962573 ## Device Facts - **Applicant:** Boehringer Mannheim Corp. - **Product Code:** [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX.md) - **Decision Date:** Jul 22, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1660 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use Control for Thyroid Stimulating Hormone assays. ## Device Story Elecsys® PreciControl TSH; liquid horse serum albumin control containing recombinant TSH; used to monitor performance of TSH assays on Elecsys® 2010 system; provides quality control verification for clinical laboratory TSH testing; standardized against WHO-reference material #80/558; stored at 2-8°C; open vial stability of 4 weeks. ## Clinical Evidence No clinical data. Bench testing only; performance characteristics established via comparison of stability and value assignment against predicate device. ## Technological Characteristics Liquid horse serum albumin matrix; contains recombinant TSH; standardized to WHO-reference material #80/558; storage 2-8°C; 4-week open vial stability; designed for Elecsys® 2010 test system. ## 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 - Elecsys® TSH CalSet ([K961491](/device/K961491.md)) ## 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} K962573 JUL 22 1996 Diagnostics # 510(k) Summary ## Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. ## 1. Submitter name, address, contact Boehringer Mannheim Corporation 2400 Bisso Lane Concord, CA 94524-4117 (510) 674-0667 Contact Person: Patricia Klimley Date Prepared: June 26, 1996 ## 2. Device name Proprietary name: Elecsys® PreciControl TSH Assay Common name: Control material Classification name: Enzyme controls (Assayed and Unassayed) ## 3. Predicate device The Boehringer Mannheim Elecsys® PreciControl TSH is substantially equivalent to the Elecsys® TSH CalSet (K961491). The intended use has been changed to a quality control material. Continued on next page page 24 {1} Diagnostics # 510(k) Summary, Continued 4. Device Description Horse serum albumin control with recombinant Thyroid Stimulating Hormone for use in TSH assays. 5. Intended use Control for Thyroid Stimulating Hormone assays. 6. Comparison to predicate device The Boehringer Mannheim Elecsys® PreciControl TSH is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the Elecsys® TSH CalSet (K961491). The following table compares the Elecsys® PreciControl TSH with the predicate device, Elecsys® TSH CalSet. ## Similarities: - Same formulation. - Same matrix: Horse serum matrix - Same analyte: recombinant Thyroid Stimulating Hormone - Standardization: World Health Organization (WHO-reference material # 80/558) - Storage conditions: 2 - 8°C - Application test system: Elecsys® 2010 - Reconstitution: none required, liquid - Open vial stability: 4 weeks at 2 - 8°C - Manufacturer: Boehringer Mannheim Germany Continued on next page {2} 510(k) Summary, Continued Diagnostics ## 6. Comparison to predicate device cont. ### Differences: | Feature | Elecsys® TSH CalSet | Elecsys® PreciControl TSH | | --- | --- | --- | | Target concentration | 0 and 1.4μU/mL | 0.18 μU/mL | | Intended Use | Calibration of the Elecsys TSH Assay | Monitoring assays for TSH | ### Performance Characteristics: | Feature | Elecsys® TSH CalSet | Elecsys® PreciControl TSH | | --- | --- | --- | | Open Vial Stability | 4 weeks at 2 - 8°C | 4 weeks at 2 - 8°C | | Value Assignment | standardized against WHO-reference material (#80/558) | standardized against WHO-reference material (#80/558) | page 26 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K962573](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K962573) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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