IMMULITE OPIATES SCREEN/CONTROL MODULE

{0} K962323 MAR 10 1997 DPC Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045 Tel: (213) 776-0180 Fax: (213) 776-0204 # 510 (k) Summary of Safety and Effectiveness This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92. | Name of Manufacturer: | Diagnostic Products Corporation (DPC) | | --- | --- | | Address: | 5700 West 96th Street Los Angeles, CA 90045-5597 | | Telephone Number: | (213) 776-0180 | | Facsimile Number: | (213) 776-0204 | | Contact Person: | Edward M. Levine, Ph.D. Director of Clinical Affairs | | Date of Preparation: | January 23, 1997 | | Device Name: | | | Trade: | IMMULITE® Opiates Screen | | Catalog #: | LKOS1 (100 tests), LKOS5 (500 tests) | | Common: | Reagent system designed as a semi-quantitative screen for morphine-3-glucuronide in urine. | | CFR: | 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 pharmacological actions. The opiates include drugs such as morphine, morphine glucuronide, heroin, codeine, nalorphine, and meperidine. 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. | | Classification: | Class II device (21 CFR 862.3650), 91-DJG | | Panel: | Toxicology | | Accessory Trade Name: | IMMULITE® Opiates Screen Control Module | | Catalog #: | LOSCM (2 vials x 2 mL) | | Common: | Quality Control Material (assayed & unassayed) | | CFR: | A device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. | | Classification: | Class I device (21 CFR 862.1660), 82-JJX | | Panel: | Immunology | {1} Establishment Registration #: DPC: 2017183 Substantial Equivalent Predicate Device: Emit d.a.u. Opiate Assay MultiPak (K842677), manufactured by Syva Co. Palo Alto, CA Description and Intended Use of Device: IMMULITE® Opiates ScreenOpiates Screen is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE® Automated Analyzer and is designed for use as a semi-quantitative screen for opiates and metabolites in urine. It is intended strictly for in vitro diagnostic use in the context of a program involving an established confirmatory test for opiates. Substantial Equivalence Claim: Diagnostic Products Corporation (DPC) asserts that DPC's IMMULITE® Opiates Screen is substantially equivalent to Syva's Emit d.a.u. Opiates Assay MultiPak. Intended Use Equivalence: Each product is designed for the semi-quantitative measurement of opiates in urine. Each product is intended strictly for in vitro diagnostic use, and each product provides a preliminary analytical test result. Method Comparison: The IMMULITE Opiates Screen procedure was compared to two commercially available immunoassays for opiates (Roche Abuscreen OnLine, manufactured by Roche Diagnostic Systems and Emit d.a.u. Opiate Assay, manufactured by Syva) and GC/MS on a total of 618 urine samples with a range from nondetectable to over $1000\mathrm{ng/mL}$. Randomly selected drug-free and drug-containing urine samples were obtained from the Uddevalla Hospital in Uddevalla Sjukhus, Switzerland and tested on site. The results of the comparisons are presented in the tables below. | IMMULITE Opiates Screen | | | Relative Sensitivity | Relative Specificity | | --- | --- | --- | --- | --- | | Roche Pos. | Pos. | Neg. | 96.0% | 98.6% | | | 240 | 10 | | | | | 5 | 363 | | | Agreement: 97.6% 95% Confidence Limits for Relative Sensitivity and Specificity, respectively: 92.8% - 98.1% and 96.9% - 99.6%. {2} | | | IMMULITE Opiates Screen | | Relative | Relative | | --- | --- | --- | --- | --- | --- | | | | Pos. | Neg. | Sensitivity | Specificity | | Syva Emit | Pos. | 241 | 6 | 97.6% | 98.9% | | | Neg. | 4 | 367 | | | Agreement: 98.4% 95% Confidence Limits for Relative Sensitivity and Specificity, respectively: 94.8% - 99.1% and 97.3% - 99.7%. IMMULITE Opiates Screen | | | Pos. | Neg. | Sensitivity | Specificity | | --- | --- | --- | --- | --- | --- | | GC/MS | Pos. | 230 | 5 | 97.9% | 96.1% | | | Neg. | 15 | 368 | | | Agreement: 96.8% 95% Confidence Limits for Sensitivity and Specificity, respectively: 95.1% - 99.3% and 93.6% - 97.8%. In the comparison between IMMULITE and Roche Abuscreen OnLine, 8 of the 10 "false negative" cases were negative by GC/MS and 2 of the 5 "false positive" cases were positive by GC/MS. In the comparison between IMMULITE and Syva Emit, 2 of the 6 "false negative" cases were negative by GC/MS and none of the 4 "false positive" cases were positive by GC/MS. ## IMMULITE Opiates Screen Control Module DPC's Opiates Screen Control Module is an assayed, bi-level control intended strictly for in vitro use in monitoring the performance and accuracy of the IMMULITE Opiates Screen assay. The two controls are supplied in liquid form, in 2 mL aliquots, and are sold separately from the IMMULITE Opiates Screen Kit. The control values are lot-specific, i.e., the control values are established for each control lot. The values for the Opiate controls are targeted at approximately 195 and 453 ng/mL. ## Clinical Studies: Not applicable ## Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the device is safe, effective, and performs as well as or better than the legally marketed device.  Edward M. Levine, Ph.D. Director of Clinical Affairs