← Product Code [DJG](/productcode/DJG) · K962795 # CEDIA DAU OPIATE 2K ASSAY (K962795) _Boehringer Mannheim Corp. · DJG · Oct 30, 1996 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K962795 ## Device Facts - **Applicant:** Boehringer Mannheim Corp. - **Product Code:** [DJG](/productcode/DJG.md) - **Decision Date:** Oct 30, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3650 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use The CEDIA DAU Opiate 2K Assay is a homogeneous enzyme immunoassay for the qualitative assay of opiates in human urine. Measurements are used in the diagnosis and treatment of opiate use or overdose. ## Device Story In-vitro homogeneous enzyme immunoassay for qualitative opiate detection in human urine; utilizes competitive binding between sample opiates and morphine-labeled enzymatic fragments (β-galactosidase) for morphine-specific antibodies. Recombinant DNA-derived β-galactosidase subunits (enzyme acceptor and enzyme donor) reassociate to form active enzyme; antibody binding to morphine-labeled enzyme donor inhibits reassociation. Enzyme activity is proportional to opiate concentration, measured via hydrolysis of chlorophenol red-β-D-galactopyranoside (CPRG) substrate. Performed on BM/Hitachi 717 analyzers in clinical laboratory settings. Output is qualitative opiate presence/absence based on 2000 ng/mL cutoff; assists clinicians in diagnosing and managing opiate use or overdose. ## Clinical Evidence Bench testing only. Precision evaluated using modified NCCLS protocols (N=120 per concentration level); within-run %CV ranged 1.3-1.4%, total %CV 4.4-5.0%. Sensitivity (LOD) reported at 60.9 ng/mL. Accuracy assessed via relative sensitivity (70.6%) and relative specificity (100%) compared to the predicate device. Interference testing performed for glucose, sodium chloride, protein, and urea, showing <10% error. ## Technological Characteristics Homogeneous enzyme immunoassay; competitive binding principle. Components: Recombinant β-galactosidase subunits (enzyme acceptor/donor), morphine-specific antibody, chlorophenol red-β-D-galactopyranoside (CPRG) substrate. Form factor: Liquid reagent kit for automated clinical chemistry analyzers (BM/Hitachi 717). Connectivity: Standalone analyzer-based. No specific material standards or software algorithm class mentioned. ## Regulatory Identification An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy. ## Special Controls *Classification.* Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). ## Predicate Devices - CEDIA DAU Opiate Assay ([K935346](/device/K935346.md)) ## Reference Devices - Emit® II ## 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} 09/18/96 17:36 ☐5 005/010 K962795 OCT 30 1996 # 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 (510) 674-0667 Contact Person: Betsy Soares-Maddox Date Prepared: September 18, 1996 ## 2) Device name Proprietary name: CEDIA DAU Opiate 2K Assay Common name: Homogeneous enzyme immunoassay for the determination of opiate levels in urine. Classification name: Opiate test system ## 3) Predicate device We claim substantial equivalence to the CEDIA DAU Opiate Assay (K935346). ## 4) Device Description The CEDIA® DAU Opiate 2K Assay is an in-vitro homogeneous enzyme immunoassay used for the qualitative measurement of opiates in urine. It is based on competitive binding concepts employing morphine derivative labeled enzymatic fragments (β-galactosidase) competing with sample morphine for the morphine-specific antibody. Continued on next page 24 {1} 09/18/96 17:36 ☐3 006.010 # 510(k) Summary, Continued ## 4) Device Description, cont. Using recombinant DNA techniques, the β-galactosidase molecule has been split into two totally inactive polypeptide subunits called enzyme acceptor and enzyme donor. Morphine has been covalently linked to the enzyme donor in a manner that does not prevent spontaneous reassociation of the subunits to yield active β-galactosidase enzyme. Morphine-specific antibody, by binding to the morphine on the enzyme donor will inhibit enzyme reassociation, thereby regulating the level of β-galactosidase formed. The amount of enzyme formed is proportional to the amount of opiates as monitored by the hydrolysis of the substrate chlorophenol red-β-D-galactopyranoside (CPRG). ## 5) Intended use The CEDIA DAU Opiate 2K Assay is a homogeneous enzyme immunoassay for the qualitative assay of opiates in human urine. Measurements are used in the diagnosis and treatment of opiate use or overdose. ## 6) Comparison to predicate device The Boehringer Mannheim CEDIA DAU Opiate 2K Assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Boehringer Mannheim CEDIA DAU Opiate Assay. The following table compares the CEDIA DAU Opiate 2K Assay with the predicate device, CEDIA DAU Opiate 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: - Both assays use the same CEDIA DAU Enzyme Acceptor, Enzyme Donor and Enzyme Donor Buffer components. - Both assays utilize the same antibody. - Both assays are used on the BM/Hitachi 717 analyzer using the same chemistry parameters. - Both assays are for the determination of opiates in urine. Continued on next page 25 {2} 09/18/96 17:37 ☐ 007/010 # 510(k) Summary, Continued 6) Comparison to predicate device, cont. ## Differences: | Feature | CEDIA DAU Opiate 2K | CEDIA DAU Opiate | | --- | --- | --- | | Cutoff Level | 2000 ng/mL | 300 ng/mL | | Antibody Concentration | 13 μg/mL | 3 μg/mL | | Intended Use | Qualitative | Qualitative and semiquantitative | ## Performance Characteristics: | Feature | CEDIA DAU Opiate 2K | | | CEDIA DAU Opiate | | | | --- | --- | --- | --- | --- | --- | --- | | Precision | Modified NCCLS (mA/min): | | | Modified NCCLS (mA/min): | | | | Concentration Level | 1500 | 2000 | 2500 | 225 | 300 | 375 | | N | 120 | 120 | 120 | 120 | 120 | 120 | | Within-Run | 240.1 | 296.8 | 353.8 | 269.8 | 316.8 | 361.4 | | %CV | 1.3 | 1.4 | 1.3 | 1.6 | 1.4 | 1.3 | | Total | 240.1 | 296.8 | 353.8 | 269.8 | 316.8 | 361.4 | | %CV | 4.6 | 5.0 | 4.4 | 4.2 | 4.8 | 4.2 | | Sensitivity (LOD) | 60.9 ng/mL | | | 21.6 ng/mL | | | | Accuracy | | | | | | | | Relative Sensitivity | 70.6% of CEDIA DAU Opiate | | | 100% of Emit® II | | | | Relative Specificity | 100% of CEDIA DAU Opiate | | | 100% of Emit® II | | | {3} 09/18/96 17:37 5 008/010 | Interfering substances | Less than 10 % error in drug detection at: | Less than 10 % error in drug detection at: | | --- | --- | --- | | Glucose= | 3 g/dL | 3 g/dL | | Sodium Chloride= | 6 g/dL | 6 g/dL | | Protein= | 0.5 g/dL | 0.5 g/dL | | Urea= | 5 g/dL | 6 g/dL | | Feature | CEDIA DAU Opiate 2K | CEDIA DAU Opiate | | --- | --- | --- | | Specificity | Major Detectables: Morphine Morphine-3-glucuronide Codeine Hydrocodone Hydromorphone 6 Monoacetylmorphine | Major Detectables: Morphine Morphine-3-glucuronide Codeine Hydrocodone Hydromorphone 6 Monoacetylmorphine | --- **Source:** [https://fda-staging.innolitics.com/device/K962795](https://fda-staging.innolitics.com/device/K962795) **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