← Product Code [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX) · K970984 # THE ELECSYS CALCHECK PROGESTERONE (K970984) _Boehringer Mannheim Corp. · JJX · Apr 2, 1997 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K970984 ## Device Facts - **Applicant:** Boehringer Mannheim Corp. - **Product Code:** [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX.md) - **Decision Date:** Apr 2, 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 Progesterone is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Progesterone assay. ## Device Story Calibration verification material; human serum albumin matrix spiked with progesterone; stabilizers; preservatives. Used to verify calibration assignment for Elecsys Progesterone assay on automated immunoassay analyzers. Quality controlled against Enzymun Progesterone assay kit calibrators; value assigned via ID-GC/MS comparison. Assists clinicians in ensuring assay accuracy and reliability. ## Clinical Evidence Bench testing only. Evaluation focused on value assignment and stability of the calibration verification material. ## Technological Characteristics Human serum albumin matrix; progesterone analyte; stabilizers; preservatives. Liquid form. Value assignment via ID-GC/MS comparison. ## 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} APR -2 1997 K970984 # B0EHRINGER MANNHEIM CORPORATION ## 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) 687-1850 Contact Person: Yvette Lloyd Date Prepared: March 13, 1997 | | 2. Device Name | Proprietary name: Elecsys CalCheck Progesterone Common name: Calibration Verification Material Classification name: Single (specified) analyte controls (assayed + unassayed) | | 3. Predicate device | The Boehringer Mannheim Elecsys CalCheck Progesterone is substantially equivalent to the currently marketed Tosoh Medics AIA-Pack FSH Calibration Verification Test. (K924863) | | 4. Device Description | The Boehringer Mannheim Elecsys CalCheck Progesterone is manufactured using human serum albumin, progesterone, stabilizers, and preservatives. The analyte is appropriately spiked into the calibrator matrix to the correct calibrator concentration levels. The calibrators are in process checked and quality controlled against the Enzymun® Progesterone assay kit calibrators (prepared using a similar procedure) which have been value assigned by comparison to ID-GC/MS. | Continued on next page {1} BOEHRINGER MANNHEIM CORPORATION Summary, Continued 5. Intended use The Boehringer Mannheim Elecsys CalCheck Progesterone is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Progesterone assay. 6. Comparison to predicate device The Boehringer Mannheim Elecsys® CalCheck™ Progesterone 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™ Progesterone was evaluated for value assignment and stability. page 23 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K970984](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K970984) **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