← Product Code [JIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX) · K961659 # CEDIA CORE TDM MULTI-CAL (K961659) _Boehringer Mannheim Corp. · JIX · Jun 13, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K961659 ## Device Facts - **Applicant:** Boehringer Mannheim Corp. - **Product Code:** [JIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX.md) - **Decision Date:** Jun 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1150 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The CEDIA Core TDM Multi-Cals are used to calibrate the CEDIA assays for carbamazepine, phenobarbital, phenytoin, theophylline, and valproic acid in human serum and plasma. ## Device Story CEDIA Core TDM Multi-Cals are liquid calibrators used to calibrate specific therapeutic drug monitoring (TDM) assays. Input consists of calibrator matrix containing bovine serum albumin, stabilizers, preservatives, and specific drug analytes (carbamazepine, phenobarbital, phenytoin, theophylline, valproic acid). Device functions as a reference standard to establish assay calibration curves. Used in clinical laboratory settings by laboratory technicians. Output is a set of known concentration values used to adjust assay performance. Benefits include ensuring accurate quantification of therapeutic drugs in patient serum/plasma, facilitating clinical decision-making regarding drug dosing. ## Clinical Evidence Bench testing only. Performance established via method comparison demonstrating equivalent correlation between subject calibrators and predicate kit calibrators. ## Technological Characteristics Calibrator matrix composed of bovine serum albumin, stabilizers, and preservatives spiked with carbamazepine, phenobarbital, phenytoin, theophylline, and valproic acid. Liquid form factor. Quality controlled against in-house reference calibrators value-assigned by comparison to predicate devices. ## Regulatory Identification A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.) ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. ## Predicate Devices - CEDIA Carbamazepine ([K914857](/device/K914857.md)) - CEDIA Phenobarbital ([K904413](/device/K904413.md)) - CEDIA Phenytoin ([K905689](/device/K905689.md)) - CEDIA Theophylline ([K961462](/device/K961462.md)) - CEDIA Valproic Acid (930734/2) ## 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} K96/659 Diagnostics # 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) 674-0690 extension 8415 Contact Person: Mary Koning Date Prepared: April 26, 1996 | | 2. Device name | Proprietary name: CEDIA Core TDM Multi-Cals Common name: Therapeutic drug monitoring calibrators for use in the calibration of the CEDIA assays for carbamazepine, phenobarbital, phenytoin, theophylline, and valproic acid. Classification name: Calibrators, drug mixture | | 3. Predicate device | The Boehringer Mannheim CEDIA Core TDM Multi-Cals are substantially equivalent to the kit calibrators included in CEDIA Carbamazepine (K914857), Phenobarbital (K904413), Phenytoin (K905689), Theophylline (K961462), and Valproic Acid (930734/2) Assays.. | | 4. Device Description | The CEDIA Core TDM Calibrators are manufactured using bovine serum albumin, carbamazepine, phenobarbital, phenytoin, theophylline, valproic acid, stabilizers, and preservatives. The drugs are appropriately spiked into the calibrator matrix to the correct calibrator concentration levels. The calibrators are in process checked and quality controlled against in-house reference calibrators (prepared using a similar procedure) which have been value assigned by comparison to the predicate device to ensure correct assay calibration. | Continued on next page page 21 40 {1} Diagnostics # 510(k) Summary, Continued ## 5. Intended use The CEDIA Core TDM Multi-Cals are used to calibrate the CEDIA assays for carbamazepine, phenobarbital, phenytoin, theophylline, and valproic acid in human serum and plasma. ## 6. Comparison to predicate device The Boehringer Mannheim CEDIA Core TDM Multi-Cals are substantially equivalent to the CEDIA Carbamazepine (K914857), Phenobarbital (K904413), Phenytoin (K905689), Theophylline (K961462), Valproic Acid (930734/2) Assays. The following table compares the CEDIA Core TDM Multi-Cals with the predicate devices, CEDIA Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid assay’s kit calibrators. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device is provided in attachment 6. ## Similarities: - Similar formulation. - Similar concentrations of carbamazepine, phenobarbital, phenytoin, theophylline, and valproic acid. - For the calibration of the CEDIA Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid assays. ## Differences: | Feature | Core TDM Multi-Cals | Kit Calibrators | | --- | --- | --- | | Configuration | sold separately from reagents | sold with reagents in kit | Continued on next page page 22 {2} Diagnostics # 510(k) Summary, Continued ## 6. Comparison to predicate device, (cont.) ### Performance Characteristics: | Feature | Core TDM Multi-Cals | Kit Calibrators | | --- | --- | --- | | Open Vial Stability | Stable for 30 days | Stable for 30 days | - Method Comparison: equivalent correlation between kit calibrators and CEDIA Core TDM Multi-Cals. page 23 --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K961659](https://fda.innolitics.com/submissions/TX/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K961659) **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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