← Product Code MVO · K992217 # AT HOME DRUG TEST, MODEL 9175 (K992217) _Phamatech · MVO · Jul 13, 1999 · TX · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K992217 ## Device Facts - **Applicant:** Phamatech - **Product Code:** MVO - **Decision Date:** Jul 13, 1999 - **Decision:** SESE - **Submission Type:** Special - **Device Class:** Class U - **Review Panel:** TX ## Intended Use The At Home Drug Test (model 9175) is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for these tests is as follows: methamphetamine; 500 ng/ml, THC; 50 ng/m, opiates; 300 ng/ml. This assay is intended for use in the home to assist in preventing drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a certified laboratory. ## Device Story At Home Drug Test (Model 9175) is a rapid, qualitative, one-step immunoassay for urine drug screening. Device utilizes immunochemical sandwich assay principle; specific antibodies bind to target drugs/metabolites (methamphetamine, THC, opiates) to produce visual color change. Intended for home use by lay users to assist in preventing drug abuse. Kit includes mechanism for anonymous confirmation testing at certified laboratory. Output is visual qualitative result (presence/absence of drug). Benefits include accessible, preliminary drug screening for consumers. ## Clinical Evidence Clinical evidence includes a clinical sample correlation study and a blind labeled spiked study. Correlation studies using clinical specimens showed >99% correlation with Behring EMIT II and GC/MS. Professional user clinical studies (two independent labs) demonstrated >98% overall accuracy. Consumer study with lay users demonstrated >96% overall accuracy. ## Technological Characteristics Qualitative one-step immunoassay; immunochemical sandwich assay principle; visual colorimetric readout. Designed for home use. No electronic components or software. ## Predicate Devices - ABMC (Ancramdale, NY) - Applied Biotech SureStep Test (San Diego, CA 92121) ## Reference Devices - Behring EMIT II (Cupertino, CA 95014) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ JUL 13 1999 Image /page/0/Picture/3 description: The image shows a handwritten string of characters. The characters appear to be a combination of letters and numbers. The string is "KA992217". む・リア ### 510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C) ### Identification: At Home Drug Test (9175) Description: Immunoassay for the Qualitative Detection of Methamphetamine, THC and Opiates in Urine. Name Of Manufacturer: Phamatech 9265 Activity Road #112 San Diego, California 92126, USA Intended Use: The At Home Drug Test (model 9175) is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for these tests is as follows: methamphetamine; 500 ng/ml, THC; 50 ng/m, opiates; 300 ng/ml. This assay is intended for use in the home to assist in preventing drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a certified laboratory. The At Home Drug Test, like many commercially available drug screening Technology: test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the ABMC (Ancramdale, NY) and the Applied Biotech SureStep Test (San Diego, CA 92121). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / antibody / complexes. Performance: The product performance characteristics of the At Home Drug Test were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the Phamatech At Home Drug Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of the stated target drugs in urine. Correlations studies, using clinical specimens, produced a >99% correlation when compared to the Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology. Clinical studies, performed at two independent laboratories, were also performed. In them the Pharnatech At Home Drug Test exhibited excellent overall accuracy (>98%) in the hands of professional users. A consumer study was also performed, in it the At Home Drug Test exhibited excellent overall accuracy (>96%) in the hands of lay users. For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech At Home Drug Test is substantially equivalent to a variety of detection tests currently in commercial distribution and is safe in the hands of the lay user. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is composed of three curved lines that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. Food and Drug Administration . 2098 Gaither Road Rockville MD 20850 JUL 17:3 19:3 Mr. Carl A. Mongiovi Vice President of Operations Phamatech 9265 Activity Road #112-113 San Diego, CA 92126 Re: K992217 > Trade Name: QuickScreen At Home Drug Test Model 9175 Regulatory Class: II Product Code: DJC, DJG, LDJ Dated: June 28, 1999 Received: July 1, 1999 Dear Mr. Mongiovi: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {2}------------------------------------------------ #### Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655. This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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, Steven Butman Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # INDICATIONS FOR USE Applicant: Phamatech 510 (k) Number (if known): _K 9922222- Device Name: At Home Drug Test (Model 9175) Indications for Use: A home drug screening, and if needed, confirmation service. This kit provides a nd if the success of the first for for conse of the following drugs of abuse in un A home drug screening, and it heeded, committiation oorwoor while: preliminary result for the detection/presence of the following drugs of abuse in urine: Methamphetamine, THC and Opiates ean Conger (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K992217 # PLEASE DO NOT WRITE BELOW THIS LINE Concurrence of the CDRH Office of Device Evaluation (ODE) Division Sign-off Division of Clinical Laboratory Devices 510 (k) Number: OR Prescription Use: Per 21 CFR 801.109 Over the Counter:____ --- **Source:** [https://fda.innolitics.com/device/K992217](https://fda.innolitics.com/device/K992217) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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