(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: PCP
Immunoassay for the qualitative detection of PCP in urine. 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.
The Phamatech At Home Drug Test (Model 9133) for PCP in urine was evaluated through a clinical sample correlation study, a blind labeled spiked study, and a consumer study.
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds. However, it implies that the device's performance should be "substantially equivalent to the reported performance characteristics of other commercially available tests" and should demonstrate "excellent overall accuracy."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices | In clinical specimen correlation studies, produced a >98% correlation when compared to Behring EMIT II and GC/MS methodology. Clinical studies with professional users exhibited excellent overall accuracy (>97%). |
| Excellent overall accuracy in the hands of professional users | >97% |
| Excellent overall accuracy in the hands of lay users | Overall accuracy in consumer study: 4557/4715 correct or 96.65%. Specific to PCP test interpretation by consumers: 464/499 or 93%. |
2. Sample Size and Data Provenance:
- Test Set (Clinical Sample Correlation Study):
- Sample Size: Not explicitly stated, but it involved "clinical specimens."
- Data Provenance: Not explicitly stated, but "clinical specimens" typically originate from various patient populations. The studies were performed at "two independent laboratories," suggesting a broader scope, but specific country of origin is not mentioned. It is a retrospective study using existing clinical samples.
- Test Set (Blind Labeled Spiked Study):
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated. "Spiked study" implies controlled laboratory conditions, so the origin of the base samples would be controlled.
- Test Set (Consumer Study):
- Sample Size: 4715 total interpretations for overall accuracy; 499 interpretations specifically for PCP.
- Data Provenance: Not explicitly stated regarding the origin of the consumers or their urine samples. The study involved "lay users," implying a diverse, real-world user population. It would likely be a prospective study.
3. Number of Experts and Qualifications:
- Clinical Sample Correlation Study & Clinical Studies with Professional Users: The document mentions "professional users" in clinical studies but does not specify the number of experts or their exact qualifications (e.g., "radiologist with 10 years of experience"). For the correlation to Behring EMIT II and GC/MS, it is implied that experts capable of performing and interpreting these reference methods were involved.
- Blind Labeled Spiked Study: No information provided on expert involvement.
- Consumer Study: No experts were used to establish ground truth for this specific study; the purpose was to assess lay user interpretation. However, the ground truth definitions for accuracy were based on laboratory methods like EMIT II and GC/MS.
4. Adjudication Method:
The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth in any of the studies mentioned. Ground truth was established through reference methods (Behring EMIT II and GC/MS) and spiked samples.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned that evaluates the effect size of human readers improving with AI vs. without AI assistance. This device is a standalone immunoassay kit, not an AI-assisted diagnostic tool.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The entire evaluation describes the performance of the "At Home Drug Test" algorithm/device itself in detecting PCP in urine, without human intervention as part of the detection mechanism, although human interpretation of the visual result is part of its intended use. The "clinical sample correlation study," "blind labeled spiked study," and the "consumer study" all assessed the device's standalone ability to provide a result.
7. Type of Ground Truth Used:
- Clinical Sample Correlation Study: The ground truth was established by comparison to the Behring EMIT II (an enzymatic immunoassay) and GC/MS methodology (Gas Chromatography/Mass Spectrometry), which is a definitive confirmatory method.
- Blind Labeled Spiked Study: The ground truth was based on known concentrations of PCP "spiked" into samples, allowing for precise determination of true positive and true negative results.
- Consumer Study: The ground truth for evaluating consumer interpretation accuracy was presumably derived from the results obtained from the reference methods (EMIT II/GC/MS) or spiked concentrations that the consumers were then asked to interpret.
8. Sample Size for the Training Set:
The document does not mention a separate "training set" or "validation set" in the context of machine learning. The studies described are performance evaluations of the final device, not an algorithm being developed or trained. This is a traditional immunoassay device, not an AI/ML-based device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this is not an AI/ML device requiring a training set in the conventional sense.
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DEC 3 0 1999
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
At Home Drug Test (Model 9133) ldentification:
Description: Immunoassay for the qualitative detection of PCP 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: PCP:(25 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 PCP test in this study showed accuracy to be 464/499 or 93%.
For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech At Home Drug Test Model 9133 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
DEC 3 0 1999
Mr. Carl A. Mongiovi Vice President of Operations Phamatech 9265 Activity Road Suite #112 San Diego, California 92126
Re: K994236
Trade Name: At Home Drug Test (Model 9133) Regulatory Class: II Product Code: LCM 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 (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 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
16994236 510 (k) Number (if known):
Device Name: At Home Drug Test (Model 9133)
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: РСР
Tan Coogen
(Division Sign-Off)
Division of Clinical Laboreuryvices
510(k) Number 1x994234
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:
OR
Prescription Use: Per 21 CFR 801.109 Over the Counter:
N/A