← Product Code [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX) · K964830 # ELECSYS CALCHECK LH (K964830) _Boehringer Mannheim Corp. · JJX · Dec 16, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K964830 ## Device Facts - **Applicant:** Boehringer Mannheim Corp. - **Product Code:** [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX.md) - **Decision Date:** Dec 16, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1660 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use The Boehringer Mannheim Elecsys CalCheck LH is used to verify the calibration assignment for the Boehringer Mannheim Elecsys LH assay. ## Device Story Elecsys CalCheck LH serves as calibration verification material for Elecsys LH assay; manufactured using human serum albumin, luteinizing hormone, stabilizers, and preservatives. Analyte spiked into matrix to specific concentration levels. Quality controlled against Enzymun LH assay kit calibrators, value-assigned via comparison to 2nd International Standard (NIBSC) 80/552. Used by laboratory personnel to confirm assay calibration accuracy; ensures reliable patient test results. ## Clinical Evidence Bench testing only; evaluation focused on value assignment and stability of the CalCheck material. ## Technological Characteristics Calibration verification material; composition includes human serum albumin, luteinizing hormone, stabilizers, and preservatives. Value assignment traceable to NIBSC 80/552 standard. ## 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 for FSH ([K924863](/device/K924863.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} 12/12/96 12:44 K964830 # 510(k) Summary DEC 16 1996 ## 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) 674-0690 extension 8413 Fax number: (510) 687-1850 Contact Person: Yvette Lloyd Date Prepared: December 12, 1996 ## 2. Device Name Proprietary name: Elecsys CalCheck LH Common name: Calibration Verification Material Classification name: Single (specified) analyte controls (assayed + unassayed) ## 3. Predicate device The Boehringer Mannheim Elecsys CalCheck LH is substantially equivalent to the Tosoh Medic AIA Pack for FSH. (K924863) ## 4. Device Description The Boehringer Mannheim Elecsys CalCheck LH are manufactured using human serum albumin, luteinizing hormone, stabilizers and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against the Enzymun® LH assay kit calibrators (prepared using a similar procedure), which have been value assigned by comparison to a 2nd International Standard (NIBSC) 80/552. Continued on next page {1} 12/12/96 12:44 5 # 510(k) Summary, Continued 5. Intended use The Boehringer Mannheim Elecsys CalCheck LH is used to verify the calibration assignment for the Boehringer Mannheim Elecsys LH assay. 6. Comparison to predicate device. **Performance Characteristics:** - The Elecsys® CalCheck™ LH were evaluated for value assignment and stability. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K964830](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K964830) **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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