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September 25, 2020 Guangzhou Wondfo Biotech Co., Ltd. Joe Shia

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September 25, 2020 Guangzhou Wondfo Biotech Co., Ltd. Joe Shia September 25, 2020 Guangzhou Wondfo Biotech Co., Ltd. ℅ Joe Shia Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877 Re: K202567 Trade/Device Name: Wondfo T-Dip® Multi-Drug Urine Test Panel Wondfo T-Dip® Multi-Drug Urine Test Panel Rx Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NGL, PTH, NFV, NFY, PTG, NGG, LCM, QBF, QAW, NFW Dated: September 2, 2020 Received: September 4, 2020 Dear Joe Shia: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.04.1 8 Silver Spring, MD 20993 www.fda.gov K202567 - Joe Shia Page 2 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 Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting- combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531- 542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting- mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical- devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Marianela Perez- Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure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k) SUMMARY K202567 1 Date September 22, 2020 2 Submitter Guangzhou Wondfo Biotech Co., Ltd. No. 8 Lizhishan Road, Science City, Luogang District Guangzhou, Guangdong, P.R. China 510641 3 Contact Person Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: 240-505-7880 Fax: 301-916-6213 Email: [email protected] 4 Device Name Wondfo T-Dip® Multi-Drug Urine Test Panel Wondfo T-Dip® Multi-Drug Urine Test Panel Rx 5 Classification Class II Product Code Regulation Section Panel Target Drug NFT 862.3100, Amphetamine Test Toxicology Amphetamine (AMP) System NGL 862.3650, Opiate Test System Toxicology Buprenorphine (BUP) PTH 862.3150, Barbiturate Test Toxicology Secobarbital (BAR) System NFV 862.3170, Toxicology Oxazepam (BZO) Benzodiazepine Test System NFY 862.3250, Cocaine Test System Toxicology Cocaine (COC) PTG 862.3620, Methadone Test System Toxicology 2-ethylidene-1,5- dimethyl-3,3- diphenylpyrrolidine (EDDP) NGG 862.3610, Toxicology Methamphetamine Methamphetamine Test System (MET) NGG 862.3610, Toxicology Methylenedioxymetha Methamphetamine Test System mphetamine (MDMA) NGL 862.3650, Opiate Test System Toxicology 1 Morphine (MOP/OPI) PTG 862.3620, Methadone Test System Toxicology Methadone (MTD) NGL 862.3650, Opiate Test System Toxicology Oxycodone (OXY) LCM Unclassified Toxicology Phencyclidine (PCP) QBF 862.3700 Propoxyphene test Toxicology Propoxyphene (PPX) system.
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