(15 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: Methamphetamine and Opiates
Immunoassay for the qualitative detection Methamphetamine and Opiate in urine
Here's a breakdown of the acceptance criteria and study information for the Phamatech At Home Drug Test (Model 9171) based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state pre-defined acceptance criteria with numerical targets. Instead, it justifies the device's performance through comparison to predicate devices and established laboratory methods. The "acceptance criteria" can be inferred from the reported performance which aligns with "substantially equivalent" to other commercially available tests and established lab methods.
| Analyte | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Overall Accuracy (Professionals) | >97% overall accuracy | >97% accuracy |
| Overall Accuracy (Lay Users) | >96.4% overall accuracy | >96.4% accuracy |
| Correlation with Behring EMIT II | >98% correlation | >98% correlation |
| Correlation with GC/MS | >98% correlation | >98% correlation |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Sample Correlation Study: The text mentions "Correlations studies, using clinical specimens," but does not specify the sample size for this test set.
- Blind Labeled Spiked Study: The text mentions this study but does not specify the sample size.
- Consumer Study: The text mentions this study but does not specify the sample size.
- Data Provenance: The document does not explicitly state the country of origin of the data. It mentions "Clinical studies, performed at two independent laboratories," implying prospective data collection in a clinical setting. The "consumer study" also suggests prospective data collection in a home-use setting. It does not mention retrospective data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The text does not explicitly mention "experts" in the context of establishing ground truth for the test set. Instead, it refers to:
- "Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology" as the reference for comparison in the correlation studies. These are established laboratory methods, not individual experts.
- "professional users" in the clinical studies, but their specific qualifications are not detailed beyond "professional."
4. Adjudication Method for the Test Set
The provided information does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set. The ground truth was established by comparing the device's results to established laboratory methods (EMIT II and GC/MS) and observed outcomes in clinical and consumer studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The studies focus on the device's performance in professional and lay user hands compared to reference methods, not on comparing human readers' performance with and without AI assistance. This device is an immunoassay test kit, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a way. The device itself is a qualitative immunoassay that provides a visual result. Its performance was evaluated against established laboratory methods (EMIT II and GC/MS), which can be considered a "standalone" evaluation of the assay's chemical reaction and detection capabilities, independent of human interpretation other than reading the reference method results. However, the "clinical studies" and "consumer study" inherently involve human interpretation of the device's results.
7. The Type of Ground Truth Used
The ground truth used was:
- Reference laboratory methods: Behring EMIT II and GC/MS methodology for the correlation studies.
- Observed outcomes: In the clinical and consumer studies, the "overall accuracy" implies comparison to the actual presence or absence of the target drugs, likely confirmed by the reference laboratory methods mentioned earlier or other established clinical assessments, though this is not explicitly detailed for these specific studies.
8. The Sample Size for the Training Set
The document does not mention a "training set" as this device is a qualitative immunoassay, not a machine learning or AI-based system that typically requires distinct training sets. Its development would involve assay optimization and validation rather than algorithmic training.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of an algorithm or machine learning, this question is not applicable. The development of the immunoassay itself would involve establishing the expected reactivity of the assay components with known concentrations of target drugs.
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JUN 11 1999
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
At Home Drug Test (Model 9171) Identification:
Description: Immunoassay for the qualitative detection Methamphetamine and Opiate 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 these test is as follows: methamphetamine; 500 ng/ml and 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 certified laboratory.
The At Home Drug Test, like many commercially available drug screening Technology: 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 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. In it the At Home Drug Test exhibited excellent overall accuracy (>96.4%) in the hands of lay users.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech At 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.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 11 1999
Mr. Carl A. Mongiovi Vice President of Operations Phamatech 9265 Activity Road #112 San Diego, California 92126
Re: K991824
Trade Name: OuickScreen At Home Drug Test Model 9171 Regulatory Class: II Product Code: MVO Dated: May 25, 1999 Received: May 27, 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
510 (k) Number (if known): _K 99 lな24
Device Name: At Home Drug Test (Model 9171)
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: Methamphetamine and Opiates
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of the CDRH Office of Device Evaluation (ODE)
signature
Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_K 991824
Division Sign-off Division of Clinical Laboratory Devices 2 x 1000 510 (k) Number: Prescription Use: OR Over the Counter: v Per 21 CFR 801.109
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