LABONE COCAINE METABOLITE MICRO-PLATE EIA

{0}------------------------------------------------ ## MAR - 5 2004 ## 510(k) Summary------LabOne Cocaine Metabolite Micro-Plate ElA 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 15040198 #### Date of Summary: Dec. 17, 2003 #### Correspondent: | Name: | Liuming Yu | |---------------|---------------------------| | Address: | 10101 Renner Boulevard | | | Lenexa, Kansas 66210-9752 | | Phone Number: | 913-895-2308 | | Fax Number: | 913-888-4186 | #### Product Name: Common Name: Cocaine Metabolite Micro-Plate EIA Trade Name: LabOne Cocaine Metabolite Micro-Plate EIA Classification Number: 862.3250 #### Substantially Equivalent Device: Product: STC Cocaine Metabolite Micro-Plate EIA Manufactured by: OraSure® Technologies, Inc. 510(k) Number: K973651 #### Product Description: LabOne Cocaine Metabolite Micro-Plate ELA is a solid phase competitive enzyme immunoassay for the determination of cocaine metabolites in oral fluid collected with the OraSure® Oral Specimen Collection Device. #### Intended Use: LabOne Cocaine Metabolite Micro-Plate EIA is a competitive micro-immunoassay for the qualitative detection of cocaine and its metabolites in oral fluid collected with the OraSure® Oral Fluid Specimen Collection Device. #### Comparison: LabOne Cocaine Metabolite Micro-Plate EIA, when used to determine cocaine and cocaine metabolites in oral fluid collected with the OraSure® Oral Fluid Specimen Collection Device, is substantially equivalent to the STC Cocaine Metabolite Micro-Plate ELA. Page 3 SK TX II {1}------------------------------------------------ ## Comparison Performance Data: Performance characteristic studies on precision, analytical sensitivity, interference and antibody I cross-reactivity showed that the LabOne Cocaine Metabolite Micro-Plate EIA is substantially equivalent to the STC Cocaine Metabolite Micro-Plate EIA. equivalent to the BTC Octains recimens and diluted samples with both the LabOne Cocaine Kesults Screence from patent speciale Metabolite Micro-Plate also showed that the MS with this from this two test systems are substantially equivalent when using GC/MS/MS results as reference. ### Conclusion: LabOne Cocaine Metabolite Micro-Plate EIA can be used to screen cocaine and cocaine Labone Cocains Metaoone Interes inthe OraSure® Oral Fluid Specimen Collection Device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is a stylized image of an eagle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 MAR - 5 2004 LabOne, Inc. c/o:Ms. Laura L. Danielson TUV America, Inc. 1775 Old Highway 8 New Brighton, MN 55112 Re: k040198 Trade/Device Name: LabOne Cocaine Metabolite Micro-Plate EIA Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: February 19, 2004 Received: February 20, 2004 Dear Ms. Danielson: 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 docs 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 practicc requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {3}------------------------------------------------ #### Page 2 This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter with and h your hinding of substantial equivalence of your device to a legally premits to licated 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, If you destre specific and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 Tou indy obtain 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/dsma/dsmamain.html. Sincerely yours, Jean M. Cooper, MS, DVM. Jean M. Cooper, MS, DVM. Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indication for Use Statement # 510(k) Number (if known) K O40 | 98 ## Device Name: LabOne Cocaine Metabolite Micro-Plate EIA ### Indication For Use: The LabOne Inc Cocaine Metabolite Micro-Plate Enzyme ImmunoAssay (EIA) is intended for the qualitative detection of cocaine and its metabolite, benzylecgonine, in oral fluid with the Orasure® Oral Specimen Device. It is a screen test with a cutoff set at 10 ng/ml of benzoylecgonine per ml of oral fluid. (See Cross Reactivity section for information on cross-reactivity with cocaine). This test is intended for laboratory use only. For in vitro diagnostic use. The LabOne Inc Cocaine Metabolite Micro-Plate Enzyme ImmunoAssay (ELA) 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/mass spectroscopy (GC/MS/MS) is the recommended confirmatory method. The LabOne Cocaine Metabolite Micro-Plate EIA Calibrators are intended for medical purposes for use with the LabOne Cocaine Metabolite Micro-Plate EIA to establish points of reference that are used in determination of values in the measurement of cocaine metabolite in saliva. The LabOne Cocaine Metabolite Micro-Plate EIA Controls are intended for use as an assayed quality control matrix to monitor the precision and accuracy of the laboratory testing procedures for cocaine metabolite. Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Carol C. Benson Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K040198