← Product Code [DKB](/productcode/DKB) · K963191 # CEDIA ANTIBIOTIC TDM MULTI-CALS (K963191) _Boehringer Mannheim Corp. · DKB · Sep 10, 1996 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K963191 ## Device Facts - **Applicant:** Boehringer Mannheim Corp. - **Product Code:** [DKB](/productcode/DKB.md) - **Decision Date:** Sep 10, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3200 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use The CEDIA Antibiotic TDM Multi-Cals are used to calibrate the CEDIA assays for tobramycin and gentamicin in human serum and plasma. ## Device Story CEDIA Antibiotic TDM Multi-Cals; liquid calibrators for tobramycin and gentamicin assays. Manufactured using bovine serum albumin, tobramycin, gentamicin, stabilizers, and preservatives. Used in clinical laboratory settings to calibrate CEDIA assays; ensures accurate drug concentration measurement in human serum and plasma. Quality controlled against in-house reference calibrators value-assigned via comparison to predicate devices. Sold separately from assay reagents. ## Clinical Evidence Bench testing only. Method comparison study demonstrated equivalent correlation between the subject CEDIA Antibiotic TDM Multi-Cals and the predicate device kit calibrators. ## Technological Characteristics Liquid calibrator matrix containing bovine serum albumin, tobramycin, gentamicin, stabilizers, and preservatives. Calibrator concentrations matched to predicate assay requirements. Quality control performed against in-house reference standards. ## Regulatory Identification A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (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 tobramycin ([K912143](/device/K912143.md)) - CEDIA gentamicin ([K913470](/device/K913470.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} K963191 SEP 10 1996 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 8240 Contact Person: Betsy Soares-Maddox Date Prepared: August 14, 1996 ## 2. Device name Proprietary name: CEDIA Antibiotic TDM Multi-Cals Common name: Therapeutic drug monitoring calibrators for use in the calibration of the CEDIA assays for tobramycin and gentamicin. Classification name: Calibrators, drug mixture ## 3. Predicate device The Boehringer Mannheim CEDIA Antibiotic TDM Multi-Cals are substantially equivalent to the kit calibrators included in CEDIA tobramycin (K912143) and gentamicin (K913470) assays. ## 4. Device Description The CEDIA Antibiotic TDM Calibrators are manufactured using bovine serum albumin, tobramycin, gentamicin, 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 {1} Diagnostics # 510(k) Summary, Continued ## 5. Intended use The CEDIA Antibiotic TDM Multi-Cals are used to calibrate the CEDIA assays for tobramycin and gentamicin in human serum and plasma. ## 6. Comparison to predicate device The Boehringer Mannheim CEDIA Antibiotic TDM Multi-Cals are substantially equivalent to the kit calibrators included in CEDIA tobramycin (K912143) and gentamicin (K913470) assays. The following table compares the CEDIA Antibiotic TDM Multi-Cals with the predicate devices, CEDIA Tobramycin and Gentamicin 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 concentrations of tobramycin and gentamicin. ### Differences: | Feature | Antibiotic TDM Multi-Cals | Kit Calibrators | | --- | --- | --- | | Configuration | sold separately from reagents | sold with reagents in kit | Continued on next page page 24 {2} Diagnostics # 510(k) Summary, Continued 6. Comparison to predicate device, (cont.) ## Performance Characteristics: - Method Comparison: equivalent correlation between predicate device kit calibrators and CEDIA Antibiotic TDM Multi-Cals. page 25 --- **Source:** [https://fda-staging.innolitics.com/device/K963191](https://fda-staging.innolitics.com/device/K963191) **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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