AT HOME DRUG TEST, MODEL 9078 by PHAMATECH

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

Device Description

Immunoassay for the qualitative detection of THC in urine. The At Home Drug Test 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: THC (or marijuana): 50 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 certified laboratory. The At Home Drug 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the At Home Drug Test (Model 9078), based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated Goal)	Reported Device Performance (THC)
Qualitative detection of THC in urine at 50 ng/ml cut-off.	97.0% accuracy (consumer study)
Overall accuracy in hands of professional users (for target drugs)	>97% overall accuracy
Substantially equivalent to predicate devices	>98% correlation to Behring EMIT II and GC/MS (clinical correlation studies)

Notes on Acceptance Criteria:

The document implies that "substantial equivalence" to existing, legally marketed predicate devices in terms of performance (accuracy, correlation) is the primary acceptance criterion.
Specific numerical thresholds for acceptance (e.g., "must achieve X% accuracy") are not explicitly stated, but are demonstrated through high correlation and accuracy figures.

2. Sample Sizes Used for the Test Set and Data Provenance:

Clinical Sample Correlation Study: Not explicitly stated, but produced a >98% correlation.
Clinical Studies (Professional Users): Not explicitly stated. Performed at two independent laboratories. Data provenance is not explicitly mentioned but implies clinical settings.
Consumer Study:
- Overall Accuracy: 4715 total interpretations for all target drugs (4557 correct).
- THC Accuracy (Component of Consumer Study): 943 interpretations (915 correct).
- Data Provenance: Retrospective, as it describes a completed study. The country of origin isn't specified, but given the manufacturer's location (San Diego, California, USA) and FDA submission, it's highly likely to be the USA.

3. Number of Experts and Qualifications for Ground Truth for the Test Set:

Clinical Sample Correlation Study: The "Behring EMIT II" and "GC/MS methodology" are considered the reference methods for establishing ground truth. These are laboratory-based, objective tests, not relying on human expert interpretation for individual results.
Clinical Studies (Professional Users): "Professional users" are mentioned, but their exact qualifications or how many were involved in establishing ground truth (vs. performing the test) are not specified. Given the context of a drug test, qualified laboratory personnel or medical professionals would establish ground truth using reference methods.
Consumer Study: The ground truth for this study would have been established by comparing the lay user's interpretation to results from a definitive lab method (like GC/MS or EMIT II) on the same urine samples. The number of experts involved in determining this ground truth for the consumer study is not provided, but it would involve laboratory technicians or chemists operating the reference methods.

4. Adjudication Method for the Test Set:

Not explicitly stated as a separate process. The ground truth appears to be established by comparison to reference methods (Behring EMIT II and GC/MS), which are objective and do not typically require multi-expert adjudication in the same way, for example, image interpretation might. The results of the device are compared directly to these established reference results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study described. The document focuses on the standalone performance of the device and its correlation with laboratory methods. It does not evaluate how human readers (interpreting the device) improve with AI assistance, as this is a simple visual immunoassay test, not an AI-powered diagnostic.

6. Standalone (Algorithm Only) Performance:

Yes, standalone performance was done. The entire study describes the performance of the "At Home Drug Test (Model 9078)" as a standalone device. Its results are compared to established reference methods (EMIT II, GC/MS) and its accuracy is reported independently.

7. Type of Ground Truth Used:

Laboratory Reference Methods: The primary ground truth for the clinical studies was established using:
- Behring EMIT II: An immunoassay for drug detection.
- GC/MS (Gas Chromatography/Mass Spectrometry): A highly accurate and definitive method for identifying and quantifying substances in a sample, often considered the "gold standard" for drug testing.

8. Sample Size for the Training Set:

Not explicitly mentioned. As this is an immunoassay device (visual color sandwich one-step technology) and not an AI/machine learning model that undergoes "training," the concept of a training set in that context does not apply. The device's performance is determined by its inherent chemical and biological properties, not by a trained algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8 above. Immunoassays are developed based on established biochemical principles and validated against known concentrations of analytes, rather than being "trained" with ground truth data in the way an AI algorithm would be.

Summary

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K994220

510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)

At Home Drug Test (Model 9078) Identification:

Description: Immunoassay for the qualitative detection of THC in urine

Name Of Manufacturer:

Phamatech 9265 Activity Road #112 San Diego, California 92126, USA

Intended Use: The At Home Drug Test 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: THC (or marijuana): 50 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 certified laboratory.

The At Home Drug Test, 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 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 >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 QuickScreen™ exhibited excellent overall accuracy (>97%) in the hands of professional users. A comsumer study was also performed. The At Home Drug Test exhibited excellent overall accuracy (4557/4715 correct or 96.65%) in the hands of lay users. Consumer interpretation of the THC test in this study showed accuracy to be 915/943 or 97.0%.

Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech At Home Drug Test Model 9078 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

DEC 3 0 1999

Mr. Carl A. Mongiovi Vice President of Operations Phamatech 9265 Activity Road Suite #112 San Diego, California 92126

Re: K994220

Trade Name: At Home Drug Test (Model 9078) Regulatory Class: II Product Code: LDJ Dated: August 25, 1999 Received: December 15, 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.

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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

16994220 510 (k) Number (if known):

Device Name: At Home Drug Test (Model 9078)

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

Sein Coogh
(Division Sign-Off)

Division of Clinical Laboratory Levices 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:

Over the Counter: OR Prescription Use: Per 21 CFR 801.109

Regulation Number and Section

§ 862.3870 Cannabinoid test system.

(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).