QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA

{0}------------------------------------------------ ## 510(k) Summary---------------------------------------------------------------------------------------------------------------------------------------------------------------- This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 The assigned 510(k) number is 1002929 Date of Summary: Sep. 15, 2006 ### Correspondent: Name: Address: E-mail Phone Number: Fax Number: Liuming Yu 10101 Renner Boulevard Lenexa, Kansas 66210-9752 913-895-2308 913-577-1429 liuming.yu@labone.com DEC 1 8 2006 ## Product Name: Common Name: Quest Diagnostics Urine Cocaine Metabolite EIA Trade Name: Quest Diagnostics Urine Cocaine Metabolite EIA Classification Number: 862.3250 #### Substantially Equivalent Device: Product: DAT II Cocaine II Manufactured by: Roche Diagnostics Cooperation 510(k) Number: K023281 #### Product Description: Quest Diagnostics Urine Cocaine Metabolite EIA is a competitive homogenous enzyme immunoassay for the determination of cocaine metabolites in urine specimens. #### Intended Use: Quest Diagnostics Urine Cocaine Metabolite EIA is a competitive homogenous enzyme immunoassay for the qualitative detection of benzoylecgonine, the primary cocaine metabolite, in urine human specimens on automated clinical chemistry analyzers. #### Comparison: Quest Diagnostics Urine Cocaine Metabolite EIA, when used to qualitatively determine benzoylecgonine in urine specimens, is substantially equivalent to the DAT II Cocaine II assay manufactured by Roche Diagnostics Cooperation. ### Comparison Performance Data: Performance characteristic studies on precision, analytical sensitivity, interference and antibody cross-reactivity showed that the Quest Diagnostics Urine Cocaine Metabolite EIA is substantially equivalent to the DAT II Cocaine II assay. Results screened from patient specimens with both the Quest Diagnostics Urine Cocaine Metabolite EIA and the DAT II Cocaine II assay also showed that the qualitative results from this two test systems are substantially equivalent when using GC/MS results as reference. #### Conclusion: Quest Diagnostics Urine Cocaine Metabolite EIA can be used to qualitatively screen benzoylecgonine, the primary cocaine metabolite, in human urine specimens. {1}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Mr. Liuming Yu Quest Diagnostics 10101 Renner Boulevard Lenexa, KS 66219 DEC 1 8 2006 Re: k062929 Trade/Device Name: Quest Diagnostics Urine Cocaine Metabolite EIA Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: September 28, 2006 Received: September 28, 2006 Dear Mr. Yu: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {2}------------------------------------------------ Page 2 - This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Alberto Gutierrez, Ph.D. Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known): K062929 Device Name: Quest Diagnostics Urine Cocaine Metabolite EIA Indications For Use: The Quest Diagnostics Urine Cocaine Metabolite EIA is intended for the qualitative detection of benzoylecgonine, the primary metabolite of cocaine, in human urine on automated clinical chemistry analyzers. It is a screen test with cutoffs of 300 ng/ml and 150 ng/ml of benzoylecgonine per ml of urine. This test is intended for laboratory use only. For in vitro diagnostic use. The Quest Diagnostics Urine Cocaine Metabolite EIA provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain confirmed analytical results a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. The Quest Diagnostics Urine Cocaine Metabolite EIA Calibrators are intended for medical purposes and for use only with the Quest Diagnostics Urine Cocaine Metabolite EIA to establish points of reference that are used in the determination of values in the measurement of benzoylecgonine in urine. The Quest Diagnostics Urine Cocaine Metabolite EIA Controls are intended for use as an assay quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for benzoylecgonine. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | | |-------------------------------------------------------------------|-------------------| | Division Sign-Off | | | Office of In Vitro Diagnostic Device Evaluation and Safety | Page 1 of _______ | | 510(k) | K062929 |