(20 days)
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: cocaine and THC
Immunoassay for the qualitative detection of cocaine and THC in urine. The At Home Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drugs or their metabolites by visual color sandwich one step immunoassay technology.
The provided text describes the "At Home Cocaine & THC Screening Test (Model 9170)", a qualitative immunoassay for the detection of cocaine and THC in urine, intended for home use to prevent drug abuse.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cocaine Cut-off Concentration | 300 ng/ml (specified) |
| THC Cut-off Concentration | 50 ng/ml (specified) |
| Correlation with Behring EMIT II and GC/MS (Clinical Specimens) | >98% correlation |
| Overall Accuracy (Professional Users) | >97% overall accuracy |
| Overall Accuracy (Lay Users) | >97% overall accuracy |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document mentions "clinical sample correlation study" and a "blind labeled spiked study" for performance evaluation. However, the specific sample sizes for these test sets are not provided.
The data provenance is not explicitly stated in terms of country of origin. The studies were described as "clinical sample correlation study" and "clinical studies, performed at two independent laboratories," implying real-world or simulated clinical data. The term "spiked study" suggests some samples were prepared with known concentrations of the target substances in a laboratory setting. The studies include both "clinical specimens" and presumably simulated samples for the "blind labeled spiked study." It is retrospective and/or prospective depending on the nature of the "clinical sample correlation study" and the "blind labeled spiked study" but the document doesn't specify.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document doesn't explicitly state the number of experts used to establish ground truth. However, for "correlation studies, using clinical specimens," the comparison was made to "Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology." Thus, the ground truth was established by these established, presumably accurate, laboratory methods. The "clinical studies, performed at two independent laboratories" likely also relied on these expert-operated laboratory methods for confirmation. The professionals performing these tests would be qualified laboratory technicians or scientists.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method in the way medical imaging studies sometimes employ (e.g., 2+1, 3+1). The ground truth appears to be based on the results of established analytical methods (Behring EMIT II and GC/MS), which are considered definitive for drug detection. Discrepancies, if any, would likely be resolved through retesting or further analysis using these gold standard methods rather than through expert consensus of multiple human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not conducted or reported. The study focused on the device's performance against established laboratory methods and its accuracy in the hands of both professional and lay users, not on comparing human readers' performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Yes, a standalone performance evaluation was done. The device itself is a qualitative immunoassay, and its performance (correlation with established methods, accuracy with professional and lay users) was assessed. The "human-in-the-loop" here refers to the user interpreting the visual color change. The accuracy numbers (>97%) reflect the device's performance when interpreted by either professional or lay users, implying the device's inherent ability to detect the substances. The document distinguishes between professional and lay users, indicating that the device's standalone performance, when interpreted, was evaluated in both contexts.
7. Type of Ground Truth Used:
The primary ground truth used was comparative analysis with established laboratory methods, specifically:
- Behring EMIT II: An immunoassay widely used for drug screening.
- GC/MS (Gas Chromatography/Mass Spectrometry): Considered a gold standard confirmatory method for drug identification and quantification.
8. Sample Size for the Training Set:
The document does not mention a training set or its sample size. This is expected as the "At Home Cocaine & THC Screening Test" is an immunoassay (a chemical test), not a machine learning or AI-based device that would typically require a training set. Its principles are based on known chemical reactions and antibody-antigen binding.
9. How the Ground Truth for the Training Set Was Established:
Since there is no training set mentioned or implied for this type of device, the question of how its ground truth was established is not applicable.
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JUN 1 1990
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
At Home Cocaine & THC Screening Test (Model 9170) Identification:
Description: Immunoassay for the qualitative detection of cocaine and THC in urine,
Name Of Manufacturer:
Phamatech 9265 Activity Road #112 San Diego, California 92126, USA
Intended Use: The At Home Cocaine & THC Screening Test is a rapid, qualitative immunoassav for the detection of target drugs/metabolites in urine. The cut-off concentration for these tests is as follows: cocaine; 300 ng/ml and 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 certified laboratory.
Technology: The At Home Test, like many commercially available drug screening 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), the Applied Biotech SureStep Test (San Diego, CA 92121) and the Phamatech QuickScreen™ At Home Drug Test (San Diego, CA). 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 Cocaine and THC Screening Test were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the Phamatech At HomeTest 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 HomeCocaine & THC test exhibited excellent overall accuracy (>97%) in the hands of professional users. A consumer study was also performed., in it the At Home Cocaine & THC Test exhibited excellent overall accuracy (>97%) in the hands of lay users.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech At Home Cocaine & THC Screening Test 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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Public Health Service
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle's head and neck, with three lines representing the feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The logo is simple and recognizable, and it is often used on official documents and websites.
Carl A. Mongiovi JUN 1 1999 Vice President of Operations Phamatech 9265 Activity Road #112 San Diego, CA 92126
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re : K991641 Trade Name: At Home Cocaine & THC Screening Test (Model 9170) Regulatory Class: II Product Code: DIO, LDJ Dated: May 08, 1999 Received: May 12, 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls The general controls provisions of the provisions of the Act. Act include requirements for annual registration, listing of devices, qood 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 Requlations, 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 Requlation (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.
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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 Putman
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 Cocaine & THC Screening Test
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: cocaine and THC
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
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