(14 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: Opiates
Immunoassay for the qualitative detection of Opiates in urine
Here's a breakdown of the acceptance criteria and the study details for the At Home Drug Test (Model 9083), based on the provided CPT code K994234:
Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria (e.g., "must achieve X% accuracy"). Instead, it compares the device's performance to predicate devices and asserts substantial equivalence based on the observed correlation and accuracy. The primary performance metrics reported are correlation and overall accuracy.
| Acceptance Criteria (Implied) | Reported Device Performance (Opiates) |
|---|---|
| High correlation with GC/MS and predicate immunoassay | >98% correlation with Behring EMIT II and GC/MS methodology |
| High overall accuracy for professional users | >97% overall accuracy |
| High overall accuracy for lay users | 97.3% (918/943) for Opiates |
Study Details
2. Sample size used for the test set and the data provenance:
- Clinical Sample Correlation Study: The exact sample size is not explicitly stated, but it refers to "clinical specimens." The provenance is also not specified beyond "clinical specimens."
- Blind Labeled Spiked Study: No sample size is given.
- Professional User Study: No explicit sample size is given, but it states "excellent overall accuracy (>97%) in the hands of professional users."
- Consumer Study: The overall consumer study involved 4557/4715 correct readings. For opiates specifically, the test set size was 943 (918 correct readings). The provenance is not specified other than "consumer study." All studies appear to be prospective to evaluate the device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Clinical Sample Correlation Study: The ground truth was established by two methodologies:
- Behring EMIT II: This is another immunoassay, likely read by laboratory professionals.
- GC/MS methodology: This is a gold standard laboratory confirmation method, performed by trained laboratory technicians/analysts. The number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed.
- Professional User Study & Consumer Study: The "ground truth" for evaluating the At Home Drug Test's performance was the GC/MS methodology. The number and qualifications of experts involved in running the GC/MS are not specified beyond being standard laboratory practice.
4. Adjudication method for the test set:
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). For the clinical correlation study, the comparison was made against established laboratory methods (Behring EMIT II and GC/MS). For the professional and consumer studies, the At Home Drug Test's results were compared against GC/MS results. It implies a direct comparison rather than an adjudication process requiring multiple readers for the device itself.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This device is an in vitro diagnostic immunoassay for drug detection, not an AI-powered diagnostic imaging device. Therefore, an MRMC comparative effectiveness study to assess the impact of AI assistance on human readers was not performed and is not applicable. The device provides a direct qualitative result (positive/negative) via visual color change, which is then interpreted by the user.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone test in the sense that it produces a result without human interpretation of complex data (like an algorithm analyzing an image). However, it is an "At Home Drug Test," meaning it relies on a human user to perform the test and visually interpret the result. Therefore, studies were done for both professional users and lay users, indicating that the "human-in-the-loop" aspect is crucial, especially for the home-use context. The device's performance is its standalone performance in a qualitative sense, but the interpretation step is performed by a human.
7. The type of ground truth used:
The primary ground truth used for establishing the performance characteristics was GC/MS (Gas Chromatography/Mass Spectrometry) methodology. This is a highly accurate and widely accepted laboratory confirmation method for drug presence and concentration. In some instances, another predicate immunoassay (Behring EMIT II) was also used for correlation.
8. The sample size for the training set:
The document does not explicitly mention a "training set" or "validation set" in the context of machine learning or algorithm development. This device is an immunoassay, not an AI/ML-based device. The studies described are performance evaluation studies, not algorithm training or validation studies.
9. How the ground truth for the training set was established:
As noted above, there's no mention of a "training set" because this device does not use an AI/ML algorithm that requires training. The "ground truth" for the performance evaluation studies was established using GC/MS methodology, as described in point 7.
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510 (k) SUMMARY AS REQUIRED BY SECTION 807,92(C)
ldentification: At Home Drug Test (Model 9083)
Description: Immunoassay for the qualitative detection of Opiates 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: Opiates;(2000 na/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.
The product performance characteristics of the At Home Drug Test were Performance: 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 Opiates test in this study showed accuracy to be 918/943 or 97.3%.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech At Home Drug Test Model 9083 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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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three lines representing its wings.
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: K994234
Trade Name: At Home Drug Test (Model 9083) Regulatory Class: II Product Code: DJG Dated: December 14, 1999 Received: December 16, 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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
16 99 4234 510 (k) Number (if known):
Device Name: At Home Drug Test (Model 9083)
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: Opiates
Jean Cooper
(Division Sign-Off)
Division of Clinic Mone
510(k) Number K994234
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: | ✓ |
|---|---|
| ------------------- | --- |
§ 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).