← Product Code [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX) · K963182 # ELECSYS CALCHECK CK-MB (K963182) _Boehringer Mannheim Corp. · JJX · Aug 23, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K963182 ## Device Facts - **Applicant:** Boehringer Mannheim Corp. - **Product Code:** [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX.md) - **Decision Date:** Aug 23, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1660 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use Elecsys CalCheck CK-MB is intended for use in the quantitative verification of the calibration curve established by the Elecsys CK-MB reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers. ## Device Story Elecsys CalCheck CK-MB consists of three-level lyophilized, human-based materials; used for calibration verification of CK-MB assays on Elecsys 1010/2010 immunoassay analyzers. User reconstitutes material, performs triplicate assay, and compares results against target values to verify calibration curve integrity. Used in clinical laboratory settings by laboratory personnel. Provides quality control verification to ensure accurate patient test results. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Three-level lyophilized human-based material; single analyte (CK-MB) control; intended for use on Elecsys 1010/2010 immunoassay analyzers. ## 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 - Tosoh Medic AIA-Pack HCG Calibration Verification Test Set ([K924862](/device/K924862.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} K963182 AUG 23 1996 # 510(k) Summary ## Elecsys® CalCheck™ CK-MB ### 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 9115 Hague Rd. Indianapolis, IN 46250 (317) 845-2000 Contact Person: John D. Stevens Date Prepared: August 12, 1996 ### 2) Device name Proprietary name: Elecsys CalCheck CK-MB Common name: Calibration Verification Material Classification name: Single (specified) analyte controls (assayed + unassayed) ### 3) Predicate device We claim substantial equivalence to the Tosoh Medic AIA-Pack HCG Calibration Verification Test Set, K924862. The intended use for both products is to verify the calibration curve of automated immunoassay analyzers ### 4) Device Description The Elecsys CalCheck CK-MB is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values. ### 5) Intended use Elecsys CalCheck CK-MB is intended for use in the quantitative verification of the calibration curve established by the Elecsys CK-MB reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers. 11 {1} 12 # 510(k) Summary, Elecsys® CalCheck™ CK-MB, Continued ## 6) Comparison to predicate device The Boehringer Mannheim Elecsys CalCheck CK-MB is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Tosoh Medics AIA-Pack HCG Calibration Verification Test Set, K924862. The intended use of both the Elecsys CalCheck CK-MB and the predicate device are the same in that they are intended to be used for the calibration verification for their labeled analytes on automated immunoassay analyzers. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K963182](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K963182) **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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