← Product Code [KLT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT) · K964068 # CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K964068) _Bayer Corp. · KLT · Dec 13, 1996 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K964068 ## Device Facts - **Applicant:** Bayer Corp. - **Product Code:** [KLT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT.md) - **Decision Date:** Dec 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3645 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use This in vitro method is intended to quantitatively measure carbamazepine, an anti-convulsant drug, in human serum or plasma (heparin) using Syva EMIT® 2000 Assay on a Technicon Immuno-1® system. Measurements of carbamazepine are used in the diagnosis and treatment of carbamazepine overdose and in monitoring serum levels of carbamazepine to ensure appropriate therapy. ## Device Story In vitro diagnostic assay for quantitative measurement of carbamazepine in human serum or plasma; performed on Technicon Immuno-1® system. Uses chemical reagents and calibrators to detect drug concentration; provides numerical output in μg/mL. Used in clinical laboratory settings by trained personnel. Results assist clinicians in monitoring therapeutic drug levels and managing carbamazepine overdose, ensuring appropriate patient therapy. ## Clinical Evidence Bench testing only. Performance compared against predicate using 50 clinical samples. Correlation: y = 1.07x - 0.13, r = 0.978, S_yx = 0.89 μg/mL. Precision (between-run) evaluated at multiple concentrations (2.8–16.1 μg/mL) showing CVs ranging from 4.2% to 8.7%. ## Technological Characteristics In vitro diagnostic reagent kit for automated immunoassay. Principle: quantitative measurement of carbamazepine. System: Technicon Immuno-1®. Minimum detectable concentration: 0.2 μg/mL. ## Regulatory Identification A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs. ## Predicate Devices - Syva EMIT® 2000 Carbamazepine Assay (Behring Diagnostics Inc.) ## Reference Devices - Roche COBAS FARA II® Instrument ## 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} K964068 Dec. 13, 1996 # SUMMARY OF SAFETY AND EFFECTIVENESS ## Carbamazepine Method for Bayer Technicon Immuno 1® System Listed below is a comparison of the performance between the Immuno 1 Carbamazepine method and a similar device that was granted clearance of substantial equivalence (Syva EMIT® 2000 Carbamazepine Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Carbamazepine method sheet and the Syva EMIT® 2000 Carbamazepine Assay insert. ## INTENDED USED This *in vitro* method is intended to quantitatively measure carbamazepine, an anti-convulsant drug, in human serum or plasma (heparin) using Syva EMIT® 2000 Assay on a *Technicon Immuno-1®* system. Measurements of carbamazepine are used in the diagnosis and treatment of carbamazepine overdose and in monitoring serum levels of carbamazepine to ensure appropriate therapy. | METHOD | Immuno 1 Carbamazepine | | Syva EMIT® 2000 (predicate Device) | | | --- | --- | --- | --- | --- | | Part No. | Reagents T01-3677-51 | | Reagents 4F019UL | | | | Calibrators T03-3679-01 | | Calibrators 4F109UL | | | Minimum Detectable Conc. | 0.2 μg/mL | | 0.5 μg/mL | | | Precision (Between-Run) | 2.8 μg/mL | 3.9% | 4.0 μg/mL | 7.3% | | | 9.6 μg/mL | 4.2% | 10.0 μg/mL | 5.9% | | | 16.1 μg/mL | 8.7% | 16.3 μg/mL | 5.6% | | Correlation | y = 1.07x - 0.13 | | | | | | where | | | | | | y = Immuno 1 Carbamazepine method | | | | | | x = Syva EMIT® 2000 Carbamazepine Assay* | | | | | | n = 50 | | | | | | r = 0.978 | | | | | | S_{yx} = 0.89 μg/mL | | | | | *This assay was performed on Roche COBAS FARA II® Instrument. | | | | | Gabriel J. Murada, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 10/21/96 --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K964068](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K964068) **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