← Product Code [JJY](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY) · K962575 # ELECSYS PRECICONTROL CARDIAC (K962575) _Boehringer Mannheim Corp. · JJY · Jul 22, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K962575 ## Device Facts - **Applicant:** Boehringer Mannheim Corp. - **Product Code:** [JJY](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY.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 Elecsys® CK-MB and Troponin-T assays. ## Device Story Elecsys® PreciControl Cardiac 1 and 2 are human serum albumin-based control materials containing CK-MB and Troponin-T. Used in clinical laboratory settings to monitor the performance of Elecsys® CK-MB and Troponin-T assays on the Elecsys® 2010 system. The product is reconstituted with 2 mL of distilled water and stored at 2-8°C. Healthcare providers use the control results to verify assay accuracy and precision, ensuring reliable diagnostic output for cardiac marker testing. ## Clinical Evidence No clinical data. Bench testing only, comparing target concentrations and stability profiles against predicate devices. ## Technological Characteristics Human serum matrix control material. Analytes: CK-MB and Troponin-T. Reconstitution: 2 mL distilled water. Storage: 2-8°C. Application: 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® CK-MB CalSet ([K961501](/device/K961501.md)) - Elecsys® Troponin-T CalSet ([K961500](/device/K961500.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} K962575 JUL 22 1996 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 28, 1996 | | 2. Device name | Proprietary name: Elecsys® PreciControl Cardiac 1 and 2 Common name: Control material Classification name: Enzyme controls (Assayed and Unassayed) | | 3. Predicate device | The Boehringer Mannheim Elecsys® PreciControl Cardiac 1 and 2 are substantially equivalent to the Elecsys® CK-MB and Elecsys® Troponin-T CalSets (K961501 & K961500). The intended use has been changed to a quality control material. | Continued on next page page 24 {1} Coehringer Diagnostics # 510(k) Summary, Continued 4. Device Description Human serum albumin control with CK-MB and Troponin-T for use in CK-MB and Troponin-T assays. 5. Intended use Control for Elecsys® CK-MB and Troponin-T assays. 6. Comparison to predicate device The Boehringer Mannheim Elecsys® PreciControl Cardiac 1 and 2 are substantially equivalent to the Elecsys® CK-MB and Elecsys® Troponin-T CalSets (K961501 & K961500). The intended use has been changed to a quality control material. The following table compares the Elecsys® PreciControl Cardiac 1 and 2 with the predicate device, Elecsys® CK-MB and Elecsys® Troponin-T CalSets (K961501 & K961500). ## Similarities: - Same matrix: Human serum matrix - Same analytes: CK-MB and Troponin-T - Standardization: CK-MB - commercially available CK-MB test, Troponin-T - highly purified bovine cardiac troponin-T. - Storage conditions: 2 - 8°C - Application test system: Elecsys® 2010 - Reconstitution: 2 mL distilled water - Manufacturer: Boehringer Mannheim Germany Continued on next page {2} Diagnostics # 510(k) Summary, Continued ## 6. Comparison to predicate device cont. ### Differences: | Feature | Elecsys® CK-MB and Troponin-T CalSet | Elecsys® PreciControl Cardiac | | --- | --- | --- | | Target concentration | CK-MB: 0.15 and 500 ng/mL (approximately) Troponin-T: 0.021 and 25 ng/mL (approximately) | CK-MB: 6.0 and 60 ng/mL (approximately) Troponin-T: 0.2 and 6.0 ng/mL (approximately) | | Intended Use | Calibration of the Elecsys CK-MB and Troponin-T Assays | Monitoring assays for CK-MB and Troponin-T | | Open vial stability | 2 weeks at 2 - 8°C | 3 days at 2 - 8°C | ### Performance Characteristics: | Feature | Elecsys® CK-MB and Troponin-T CalSet | Elecsys® PreciControl Cardiac | | --- | --- | --- | | Open Vial Stability | 2 weeks at 2 - 8°C | 3 days at 2 - 8°C | | Value Assignment | CK-MB: 0.15 and 500 ng/mL (approximately) Troponin-T: 0.021 and 25 ng/mL (approximately) | CK-MB: 6.0 and 60 ng/mL (approximately) Troponin-T: 0.2 and 6.0 ng/mL (approximately) | page 26 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K962575](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K962575) **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