← Product Code [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX) · K970459 # ELECSYS CALCHECK CEA (K970459) _Boehringer Mannheim Corp. · JJX · Mar 6, 1997 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K970459 ## Device Facts - **Applicant:** Boehringer Mannheim Corp. - **Product Code:** [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX.md) - **Decision Date:** Mar 6, 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 AFP is used to verify the calibration assignment for the Boehringer Mannheim Elecsys AFP assay. ## Device Story Elecsys CalCheck AFP; three-level, lyophilized, human serum-based material; used to verify calibration assignment for Elecsys AFP assay. Device reconstituted, assayed in triplicate, and results compared to target values. Used in clinical laboratory settings by laboratory personnel. Provides verification of assay calibration accuracy; ensures reliable patient test results. ## Clinical Evidence No clinical data. Bench testing only; performance characteristics regarding value assignment and stability provided in labeling. ## Technological Characteristics Lyophilized human serum-based material; three-level configuration (low, mid, high); single analyte (AFP). ## 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® CalCheck™ CEA ([K963147](/device/K963147.md)) - Elecsys® CalCheck™ TSH ([K963147](/device/K963147.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} MAR - 6 1997 K970459 # 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) 827 - 8215 Fax number: (510) 687-1850 Contact Person: Patricia Klimley Date Prepared: January 29, 1997 ## 2. Device Name Proprietary name: Elecsys® CalCheck™ AFP Common name: Calibration Verification Material Classification name: Single (specified) analyte controls (assayed + unassayed) ## 3. Predicate device The Elecsys® CalCheck™ AFP is substantially equivalent to the currently marketed Elecsys® CalCheck™ CEA (K963147). ## 4. Device Description The Elecsys® CalCheck™ AFP is a three level single analyte set of lyophilized, human based materials. After reconstitution, they are assayed in triplicate and the results compared to the target values. Continued on next page page 23 {1} page 24 # 510(k) Summary, Continued ## 5. Intended use The Boehringer Mannheim Elecsys CalCheck AFP is used to verify the calibration assignment for the Boehringer Mannheim Elecsys AFP assay. ## 6. Comparison to predicate device The Elecsys® CalCheck™ AFP is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH (K963147). The following table compares the Elecsys® CalCheck™ AFP with the predicate devices, Elecsys® CalCheck™ TSH. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate devices is provided in attachment 6. ### Similarities: - Configuration: 3 CalCheck levels: low, mid, and high - Intended use: To verify calibration ### Differences: | Feature | CalCheck AFP | CalCheck TSH | | --- | --- | --- | | Matrix type | Human serum | Horse serum | | Analyte | AFP | TSH | Continued on next page {2} page 25 # 510(k) Summary, Continued 6. Comparison to predicate device, (cont.) Performance Characteristics: - Value assignment and stability --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K970459](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K970459) **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