← Product Code [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX) · K970146 # ELECSYS CALCHECK TESTOSTERONE (K970146) _Boehringer Mannheim Corp. · JJX · Jan 30, 1997 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K970146 ## Device Facts - **Applicant:** Boehringer Mannheim Corp. - **Product Code:** [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX.md) - **Decision Date:** Jan 30, 1997 - **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 Testosterone is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Testosterone assay. ## Device Story Calibration verification material; human serum albumin matrix spiked with testosterone, stabilizers, and preservatives. Used in clinical laboratories to verify calibration of Elecsys Testosterone assay on automated immunoassay analyzers. Quality controlled against ID-GC/MS. Provides healthcare providers with verification that assay calibration remains accurate, ensuring reliable patient testosterone measurement results. ## Clinical Evidence Bench testing only. Evaluation performed for value assignment and stability. Quality control verified against ID-GC/MS. ## Technological Characteristics Matrix: human serum albumin, testosterone, stabilizers, preservatives. Analyte concentration levels verified against ID-GC/MS. Form factor: liquid calibration verification material. ## 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 Medics AIA-Pack FSH Calibration Verification Test ([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} JAN 30 1997 K970146 BOEHRINGER MANNHEIM CORPORATION # 1000 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) 674-0690 extension 8413 Fax number: (510) 674-0690, x8413 Contact Person: Yvette Lloyd Date Prepared: January 13, 1997 ## 2. Device Name Proprietary name: Elecsys CalCheck Testosterone Common name: Calibration Verification Material Classification name: Single (specified) analyte controls (assayed + unassayed) ## 3. Predicate device The Boehringer Mannheim Elecsys CalCheck Testosterone is substantially equivalent to the currently marketed Tosoh Medics AIA-Pack FSH Calibration Verification Test. (K924863) ## 4. Device Description The Boehringer Mannheim Elecsys CalCheck Testosterone is manufactured using human serum albumin, testosterone, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calchecks are in process checked and quality controlled against ID-GC/MS. Continued on next page {1} page 23 # BOEHRINGER MANNHEIM CORPORATION ## Summary, Continued | 5. Intended use | The Boehringer Mannheim Elecsys CalCheck Testosterone is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Testosterone assay. | | --- | --- | | 6. Comparison to predicate device | The Boehringer Mannheim Elecsys® CalCheck™ Testosterone 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 FSH Calibration Verification Test. (K924863) Both products are intended to be used for the verification of calibration for analytes on automated immunoassay analyzers. | | 7. Performance Characteristics | The Elecsys® CalCheck™ Testosterone was evaluated for value assignment and stability. | --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K970146](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K970146) **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