(52 days)
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No
The summary describes a standard immunoassay for drug detection and does not mention any AI or ML components.
No.
This device is for drug screening and detection, providing information about drug presence rather than treating a condition or disease.
Yes
This device provides a preliminary result for the detection/presence of drugs of abuse in urine, which directly aids in identifying a condition (drug presence).
No
The device description clearly indicates an "Immunoassay for the qualitative detection of THC in urine," which is a hardware-based test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "A home drug screening... for the detection/presence of the following drugs of abuse in urine: THC (marijuana)." This clearly indicates the device is used to test a biological sample (urine) in vitro (outside the body) to provide information about a person's health status (presence of drugs).
- Device Description: The description states it's an "Immunoassay for the qualitative detection of THC in urine." Immunoassays are a common type of IVD test.
- Anatomical Site: The test is performed on "Urine," which is a biological specimen.
These characteristics align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for this test is as follows: THC; 50 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 SAMHSA certified laboratory.
A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: THC (marijuana).
Product codes (comma separated list FDA assigned to the subject device)
MVO
Device Description
Immunoassay for the qualitative detection of THC in urine.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
urine
Indicated Patient Age Range
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Intended User / Care Setting
home
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The product performance characteristics of the At Home Drug Test were based on a precision 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 drugs in urine. Correlation 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 Phamatech 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. Consumer interpretation of the cocaine test showed accuracy to be 915/943 or 97%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation 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 Phamatech At Home Drug Test exhibited excellent overall accuracy (>98%) in the hands of professional users.
Consumer interpretation of the cocaine test showed accuracy to be 915/943 or 97%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
DEC 0 6 2001
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
Identification: At Home Drug Test (Model 9079)
Description: Immunoassay for the qualitative detection of THC in urine.
Name Of Manufacturer:
Phamatech 9530 Padgett Street, Suite #101 San Diego, California 92126, USA
Intended Use: The At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for this test is as follows: THC; 50 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 SAMHSA certified laboratory.
The At Home Drug Test, like many commercially available drug screening test Technology: kits, qualitatively measures the presence of target drug and metabolites by visual color kils, qualitatively meddato the proches of such predicate devices include the Sandwich one Step Innunodour Control 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.
The product performance characteristics of the At Home Drug Test were Performance: r onomance. - The procession 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 the reported be nematter et drugs in urine. Correlation 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 Phamatech 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. Consumer interpretation of the cocaine test showed accuracy to be 915/943 or 97%
For the reasons mentioned above, it may be concluded that the Phamatech At Conclusion: 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 0 6 2001
Mr. Carl Mongiovi Vice President Phamatech, Inc. 9530 Padgett Street, Suite 101 San Diego, CA 92126
K013408 Re:
Trade/Device Name: At Home Drug Test (Model 9079) Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid Test System Regulatory Class: Class II Product Code: MVO Dated: November 15, 2001 Received: November 19, 2001
Dear Mr. Mongiovi:
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 10 more career 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 r ou may a croy is or ovisions 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 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be action and 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
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 nothication. The I Dri Intellig of baction 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 1 IT you desire spoonne arriver diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in Trive angliestions on the promotion and advertising of your device, (201) 594-4500. Traditionally, at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionals 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,
Steven Sutman
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
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INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known):
Device Name: At Home Drug Test (Model 9079)
Indications for Use:
A home drug screening, and if needed, confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: THC (marijuana).
Shoven C. Futa for Jean Cooper
(Division Sign-Off Division of Clinical Laboratory Levices 6014409 510(k) Number
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:
Prescription Use: Per 21 CFR 801.109 OR
Over the Counter: X