← Product Code [DIP](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP) · K963840 # CEDIA PHENYTOIN II ASSAY (K963840) _Boehringer Mannheim Corp. · DIP · Nov 20, 1996 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K963840 ## Device Facts - **Applicant:** Boehringer Mannheim Corp. - **Product Code:** [DIP](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP.md) - **Decision Date:** Nov 20, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3350 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use Immunoassay for the in vitro quantitative determination of phenytoin in human serum and plasma. ## Device Story CEDIA® Phenytoin II Assay is a homogeneous enzyme immunoassay for measuring phenytoin levels in human serum and plasma. The device utilizes genetically engineered β-galactosidase fragments that reassociate to form an active enzyme. Phenytoin in the patient sample competes with analyte-conjugated enzyme fragments for antibody binding sites. If phenytoin is present, it binds to the antibody, allowing the enzyme fragments to reassociate and cleave a substrate (CPRG), resulting in a color change measured spectrophotometrically at 570 nm. The assay is performed on clinical chemistry analyzers (e.g., Hitachi 911). Healthcare providers use the quantitative output to monitor phenytoin concentrations, aiding in therapeutic drug management. The assay provides a linear range of 0.6–40.0 µg/mL. ## Clinical Evidence Bench testing only. Precision studies (N=120 per level) showed within-run %CV of 1.3-3.2% and total %CV of 2.3-5.1%. Method comparison against the predicate (N=114) yielded a correlation coefficient of r=0.998 (y=1.00x - 0.17). Linearity established from 0.6 to 40.0 µg/mL. Interference testing performed for bilirubin, hemoglobin, lipemia, total protein, and rheumatoid factor. ## Technological Characteristics Homogeneous enzyme immunoassay using genetically engineered β-galactosidase fragments. Substrate: Chlorophenol red-β-D-Galactopyranoside (CPRG). Detection: Spectrophotometric at 570 nm. Sample type: Serum and plasma. Analytical range: 0.6–40.0 µg/mL. Designed for use on automated clinical chemistry analyzers (e.g., Hitachi 911). ## Regulatory Identification A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy. ## Predicate Devices - CEDIA® Phenytoin Assay ([K905689](/device/K905689.md)) ## Reference Devices - Abbott TDx® Phenytoin ## 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} K963840 NOV 20 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 P.O. Box 4117 Concord, CA 94524-4117 (510) 674 - 0690, extension 8413 Contact Person: Yvette Lloyd Date Prepared: September 20, 1996 ## 2. Device name Proprietary name: CEDIA® Phenytoin II Assay Common name: Homogeneous enzyme immunoassay for the determination of phenytoin. Classification name: Enzyme immunoassay, Diphenylhydantoin ## 3. Predicate device The Boehringer Mannheim CEDIA® Phenytoin II Assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed CEDIA® Phenytoin Assay (K905689). page 26 {1} Diagnostics ## 4. Device Description The CEDIA® Phenytoin II Assay is based on the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. In the assay, phenytoin in the sample competes with analyte conjugated to one inactive fragment of β-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive β-galactosidase fragments, and no active enzyme is formed. ## 5. Intended use Immunoassay for the in vitro quantitative determination of phenytoin in human serum and plasma. ## 6. Comparison to predicate device The Boehringer Mannheim CEDIA® Phenytoin II Assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed CEDIA® Phenytoin Assay (K905689). The following table compares the CEDIA® Phenytoin II Assay with the predicate device, CEDIA® Phenytoin Assay. 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: - Intended Use: Immunoassay for the in vitro quantitative determination of phenytoin - Sample type: Serum and plasma - Assay range: 0 - 40 µg/mL - Same Antibody - Same Conjugate Continued on next page page 27 {2} Diagnostics # 510(k) Summary, Continued ## 6. Comparison to predicate device cont. ### Differences: | Feature | CEDIA® Phenytoin II | CEDIA® Phenytoin | | --- | --- | --- | | Reaction test principle | Spectrophotometric 570 nm | Spectrophotometric 415 nm | | Instrument required | Hitachi 911 | Hitachi 704 | | Enzyme Substrate | CPRG (Chlorophenol red-β-D-Galactopyranoside) | m-CNPG (m-Cyano-p-nitrophenol-β-D-galactopyranoside) | ### Performance Characteristics: | Feature | CEDIA® Phenytoin II | | | CEDIA® Phenytoin | | | | --- | --- | --- | --- | --- | --- | --- | | Precision | Modified NCCLS (μg/mL): | | | Modified NCCLS (μg/mL): | | | | Level | Sample | Control 2 | Control 3 | Low | Mid | High | | N | 120 | 120 | 120 | 120 | 120 | 119 | | Within-Run | 6.30 | 14.80 | 26.75 | 10.7 | 17.7 | 35.4 | | %CV | 3.2 | 2.0 | 1.3 | 3.6 | 2.0 | 1.5 | | Total | 6.30 | 14.80 | 26.75 | 10.7 | 17.7 | 35.4 | | %CV | 5.1 | 3.1 | 2.3 | 4.7 | 3.8 | 3.3 | Continued on next page page 28 {3} Diagnostics # 510(k) Summary, Continued ## 6. Comparison to predicate device, (cont.) Performance Characteristics: | Feature | CEDIA® Phenytoin II | TDx Phenytoin | | --- | --- | --- | | Lower Detection Limit | 0.6 μg/mL | 0.6 μg/mL | | Linearity | 0.6 - 40.0 μg/mL | 0.6 - 40.0 μg/mL | | Method Comparison | Vs CEDIA® Phenytoin Least Squares y =1.00x - 0.17 r=0.998 SEE =0.55 N=114 Deming's y =1.00x - 0.19 r=0.998 SEE =0.39 N=114 | Vs Abbott TDx® Phenytoin Least Squares y =0.984x - 0.10 r=0.994 N=92 | Continued on next page {4} Diagnostics # 510(k) Summary, Continued ## 6. Comparison to predicate device, (cont.) Performance Characteristics: | Feature | CEDIA® Phenytoin II | CEDIA Phenytoin | | --- | --- | --- | | Interfering substances | No interference at: | No interference at: | | Bilirubin | 66 mg/dL | 50 mg/dL | | Hemoglobin | 1000 mg/dL | 1000 mg/dL | | Lipemia | 1000 mg/dL | 1000 mg/dL | | Total Protein | 12.0 g/dL | 13 g/dL | | Rheumatoid Factor | 100 IU/mL | 180 IU/mL | | Specificity | % Cross-reactivity | % Cross-reactivity | | HPPH | 1.8% | 1.4% | | 5-MPPH | 5.7% | 4.8% | page 30 --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K963840](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K963840) **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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