(14 days)
Not Found
QuickScreen At Home Drug Test, Applied Biotech SureStep Test
No
The device description explicitly states it uses visual color sandwich one step immunoassay technology, and there are no mentions of AI, ML, or related terms in the summary.
No.
The device is for drug screening and detection, not for treating or preventing disease.
Yes
The device is designed to provide a preliminary result for the detection/presence of drugs of abuse in urine, which directly serves an diagnostic purpose by identifying the presence of a specific substance in a biological sample.
No
The device description explicitly states it is an immunoassay using visual color sandwich one step immunoassay technology, which is a hardware-based test kit.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "A home drug screening... for the detection/presence of... drugs of abuse in urine." This clearly indicates a test performed on a biological sample (urine) to provide information about a person's health status (presence of drugs).
- Device Description: The description states it's an "Immunoassay for the qualitative detection of PCP in urine." Immunoassays are a common type of in vitro diagnostic test.
- Anatomical Site: The test is performed on "Urine," which is a biological specimen.
- Performance Studies: The document describes clinical studies and correlation studies using clinical specimens, which are typical for evaluating the performance of IVD devices.
- Predicate and Reference Devices: The mention of predicate and reference devices (QuickScreen At Home Drug Test, Applied Biotech SureStep Test, Behring EMIT II) further supports that this device falls within the category of IVDs, as these are likely other drug screening IVDs.
The fact that it's intended for home use by lay users doesn't change its classification as an IVD. IVDs can be designed for various settings and user types.
N/A
Intended Use / Indications for 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.
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
Product codes
LCM
Device Description
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. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / target drug / antibody / complexes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 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 consumer 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%.
Key Metrics
PCP test accuracy in consumer study: 464/499 or 93%.
Overall accuracy (consumer study): 4557/4715 correct or 96.65%.
Overall accuracy (professional users): >97%.
Correlation with Behring EMIT II and GC/MS methodology: >98%.
Predicate Device(s)
Not Found
Reference Device(s)
QuickScreen At Home Drug Test, Applied Biotech SureStep Test
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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: