← Product Code [KLT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT) · K964765 # CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY (K964765) _Chiron Diagnostics Corp. · KLT · Feb 14, 1997 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K964765 ## Device Facts - **Applicant:** Chiron Diagnostics Corp. - **Product Code:** [KLT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT.md) - **Decision Date:** Feb 14, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3645 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use For the quantitative determination of carbamazepine in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems. ## Device Story The Chiron Diagnostics ACS:180 Carbamazepine assay is an in vitro diagnostic test used for therapeutic drug monitoring. It utilizes a competitive immunoassay format based on direct chemiluminescence. Patient serum or plasma samples are processed on the ACS:180 Automated Chemiluminescence System. Carbamazepine in the sample competes with an acridinium ester-labeled carbamazepine derivative for binding sites on monoclonal mouse anti-carbamazepine antibodies coupled to paramagnetic particles. The system detects relative light units (RLUs), which are inversely proportional to the carbamazepine concentration in the sample. Results are used by clinicians to establish therapeutic doses, minimize adverse effects, and ensure patient compliance. The assay is intended for use in clinical laboratory settings. ## Clinical Evidence Bench testing only. Method comparison performed on 303 samples (range 0.87–14.06 µg/mL) against an alternate fluorescence polarization method yielded a correlation coefficient (r) of 0.96 and a regression equation of y = 1.01x + 0.71 µg/mL. Total precision (%CV) ranged from 5.4% to 6.7% based on 144 replicates per sample across 4 systems over 3 days. Minimum detectable concentration is 0.2 µg/mL. ## Technological Characteristics Competitive immunoassay using direct chemiluminescence. Reagents include acridinium ester-labeled carbamazepine derivative and monoclonal mouse anti-carbamazepine antibody coupled to paramagnetic particles. System measures relative light units (RLUs). Designed for use on the ACS:180 Automated Chemiluminescence System. ## 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 - TDx® Carbamazepine Assay ## 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} Company Confidential K964765 # Summary of Safety and Effectiveness As required by 21 CFR 807.92, the following 510(k) Summary is provided: ## 1. Submitters Information FEB 14 1997 Contact person: William J. Pignato Director of Regulatory Affairs Address: Chiron Diagnostics Corporation 63 North Street Medfield, MA 02052 Phone: 508 359-3825 Date Summary Prepared: November 22, 1996 ## 2. Device Information Proprietary Name: Chiron Diagnostics ACS:180 Carbamazepine Assay Common Name: Assay for Carbamazepine ## 3. Predicate Device Information Name: TDx® Carbamazepine Assay. Manufacturer: Abbott Laboratories ## 4. Device Description Therapeutic drug monitoring of carbamazepine helps the physician to establish the therapeutic dose based on individual response to the drug, to adjust dosage to reduce adverse effects while controlling seizures, and to ensure patient compliance with the established regimen. The Chiron Diagnostics ACS:180 Carbamazepine assay is a competitive immunoassay using direct chemiluminescent technology. Carbamazepine in the patient sample competes with an acridinium ester-labeled carbamazepine derivative in the Lite Reagent for a limited amount of monoclonal mouse anti-carbamazepine antibody, which is coupled to paramagnetic particles in the Solid Phase. An inverse relationship exists between the amount of carbamazepine present in the patient sample and the amount of relative light units (RLUs) detected by the system. Chiron Diagnostics ACS:180 Carbamazepine November 22, 1996 Page 2 {1} Company Confidential ## 5. Statement of Intended Use For the quantitative determination of carbamazepine in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems. ## 6. Summary of Technological Characteristics The Chiron Diagnostics ACS:180 Carbamazepine assay is a competitive immunoassay using direct chemiluminescent technology. ## 7. Performance Characteristics ### Expected Results A therapeutic range of 4 to 10 µg/mL (16.9 to 42.3 µmol/L) has been previously reported for carbamazepine. As with all therapeutic drug assays, each laboratory should determine the appropriateness of this range for the diagnostic evaluation of patient results. ### Sensitivity The ACS:180 Carbamazepine assay measures carbamazepine concentrations to 20 µg/mL (84.6 µmol/L) with a minimum detectable concentration of 0.2 µg/mL (0.8 µmol/L). Sensitivity is defined as the concentration of carbamazepine that corresponds to the RLUs that are two standard deviations less than the mean RLUs of 27 replicate determinations of the carbamazepine zero standard. ### Assay Reportable Range The ACS:180 Carbamazepine assay measures carbamazepine concentrations up to 20 µg/mL (84.6 µmol/L) with a minimum detectable concentration of 0.2 µg/mL (0.8 µmol/L). ### Method Comparison For 303 samples in the range of 0.87 to 14.06 µg/mL (3.68 to 59.47 µmol/L), the relationship between the ACS:180 Carbamazepine assay and an alternate fluorescence polarization method is described by the equation: $$ \text{ACS:180 Carbamazepine} = 1.01 \times (\text{alternate method}) + 0.71 \mu\text{g/mL} $$ $$ \text{Correlation coefficient (r)} = 0.96 $$ Chiron Diagnostics ACS:180 Carbamazepine November 22, 1996 Page 3 {2} Company Confidential ## Precision Six samples were assayed 6 times in 6 assays, on each of 4 systems (n = 144 for each sample), over a period of 3 days. The following results were obtained: Total precision (%CV) ranged from 5.4 to 6.70 Chiron Diagnostics ACS:180 Carbamazepine November 22, 1996 Page 4 --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K964765](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLT/K964765) **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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