(62 days)
9150T
Not Found
No
The device description and performance studies indicate a traditional immunoassay technology with visual interpretation, not AI/ML. There are no mentions of AI, ML, or related concepts.
No.
The device is a diagnostic tool for drug screening, not a therapeutic device that treats or prevents a disease or condition.
Yes
The device provides a preliminary result for the detection/presence of drugs of abuse, which is a form of diagnosis for the presence of these substances.
No
The device description clearly describes a physical immunoassay test kit ("At Home Drug Cup") that uses visual color changes to detect drugs in urine. It does not mention any software component as the primary medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to detect the presence of drugs of abuse in urine, which is a biological specimen. This is a classic example of an in vitro diagnostic test.
- Device Description: The device is a rapid, qualitative immunoassay that analyzes a biological sample (urine) to determine the presence of specific substances (drugs/drug metabolites). This aligns with the definition of an IVD.
- Mechanism: The device uses immunochemical technology to detect analytes in a sample, which is a common method for IVD tests.
- Performance Studies: The performance studies evaluate the device's accuracy in detecting the target substances in clinical specimens and spiked samples, which are typical studies for validating an IVD.
- Predicate Devices: The predicate devices listed are also home drug tests, which are generally classified as IVDs.
The fact that it's intended for home use by lay users and provides a preliminary result that can be confirmed by a laboratory does not change its classification as an IVD. It is still a test performed in vitro on a biological sample to provide diagnostic information.
N/A
Intended Use / Indications for Use
The At Home Drug Cup is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentration for this test is as follows: amphetamine and MDA; 1000 ng/ml, methamphetamine and MDMA; 500 ng/ml, THC (or marijuana); 50 ng/ml, cocaine; 300 ng/ml, opiates; 300 ng/ml. This assay is intended for use in the home to assist in the prevention of 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: Amphetamine, MDA, Methamphetamine, MDMA , THC, Cocaine and Opiates.
Product codes
MVO, LAF, DKZ, DIO, DJG, LDJ
Device Description
Immunoassay for the qualitative detection of amphetamine, MDA methamphetamine, MDMA, THC, cocaine and opiates in urine
The At Home Drug Cup, like many commercially available drug screening test Technology: 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 QuickScreen At Home Drug Test (9150T) 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 / complexes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This assay is intended for use in the home to assist in the prevention of drug abuse.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The product performance characteristics of the At Home Drug Cup 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 Cup 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 >98% 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 (>97%) in the hands of professional users. A comsumer study was also performed. The At Home Drug Cup exhibited excellent overall accuracy (388/400 correct or 97%) in the hands of lay users.
Key Metrics
98% correlation, >97% accuracy (professional users), 388/400 correct or 97% accuracy (lay users)
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
APR 1 4 2003
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
Identification: At Home Drug Cup (Model 9150X)
Description: Immunoassay for the qualitative detection of amphetamine, MDA methamphetamine, MDMA, THC, cocaine and opiates in urine
| Name Of Manufacturer: | Phamatech
9530 Padgett Street, Suite 101
San Diego, California 92126, USA |
| ----------------------- | --------------------------------------------------------------------------------- |
|---|
Intended Use: The At Home Drug Cup is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentration for this test is as follows: amphetamine and MDA; 1000 ng/ml, methamphetamine and MDMA; 500 ng/ml, THC (or marijuana); 50 ng/ml, cocaine; 300 ng/ml, opiates; 300 ng/ml. This assay is intended for use in the home to assist in the prevention of 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 Cup, like many commercially available drug screening test Technology: 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 QuickScreen At Home Drug Test (9150T) 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 / complexes.
Performance: The product performance characteristics of the At Home Drug Cup 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 Cup 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 >98% 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 (>97%) in the hands of professional users. A comsumer study was also performed. The At Home Drug Cup exhibited excellent overall accuracy (388/400 correct or 97%) in the hands of lay users.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech At Home Drug Cup Model 9150X is substantially equivalent to a variety of detection tests currently in commercial distribution and is safe in the hands of the lay user.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 4 2003
Mr. Carl Mongiovi Vice President Pharmatech, Inc. 9530 Padgett Street - Suite 101 San Diego, CA 92126
Re: K030447 Trade/Device Name: At Home Drug Cup (Model 9150X) Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: MVO; LAF; DKZ; DIO; DJG; LDJ Dated: March 17, 2003 Received: March 24, 2003
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 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. Iisting 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 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion 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 Division 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 vours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety 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 Cup (Model 9150X)
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: Amphetamine, MDA, Methamphetamine, MDMA , THC, Cocaine and Opiates.
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of the CDRH Office of Device Evaluation (ODE)
Jean Cooper
Division Sign-off Division of Clinical Laboratory Devices 510 (k) Number:
OR
Prescription Use: Per 21 CFR 801.109 Over the Counter: v