QUEST DIAGNOSTICS HAIRCHECK-DT (THC)

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/0/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo is circular, with text around the perimeter. In the center of the circle is an image of an eagle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JUN 1 4 2004 Dr. James Bourland Technical Director Quest Diagnostics, Inc. 4230 Burnham Ave. Las Vegas, NV 89119 k040257 Re: Trade/Device Name: Quest Diagnostics Haircheck-DT (THC) Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ Dated: April 28, 2004 Received: May 5, 2004 Dear Dr. Bourland: We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed four becamed the device is substantially equivalent (for the indications ferenced above and in the enclosure) to legally marketed predicate devices marketed in interstate for use surver in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prior to they 2011-12-11 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 r ou may, morelory, mains 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 your device is trademical controls. Existing major regulations affecting your device it may oc subject to bach additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 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 I lease be advised that I Dr over device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or any I cacal statutes and regarments, 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). {1}------------------------------------------------ ## Page 2 This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter with anow you to begin milities of your device of your device to a legally premarket notification: "The Pro Print of Stification 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, II you desire specific information as vertising of your device, please contact the Office of of questions on the promotion and Safety at (301) 594-3084. Also, please note the In Ville Diagliostic De Hose Wina by reference to premarket notification" (21CFR Part 807.97). Tegulation childed, "Misormation on your responsibilities under the Act from the Tod inay oodain other generational 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, 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 {2}------------------------------------------------ ## Appendix 4 ## Indications for Use 510(k) Number (if known): K040257 Quest Diagnostics Haircheck-DT (THC) Device Name: Indications For Use: The QUEST DIAGNOSTICS HairCheck-DT (THC-COOH) is a bipartite device TIC QUEST DITIONOBE iso nunosorbent assay (ELISA) for qualitative screening at employing of THC-COOH and Gas Chromatography - Mass Spectrometry - Mass r.o pgring of TTC OOOT and Oast and the final quantitative reporting of Speculometry (OO Mb MB) 201 oles for the purpose of identifying chronic marijuana ITIC-COOT in halfall has on evaluated for use with hair specimens other than head. use. This process is intended exclusively for in-house professional use only. The process I his process is michaea eneraler copy in Clinical consideration and professional judgement should be applied to any drug of abuse test result. Prescription Use _____________________________________________________________________________________________________________________________________________________________ Counter Use (Part 21 CFR 801 Subpart D) Subpart C) AND/OR Over-The- (21 CFR 807 (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 510(k)