(52 days)
Not Found
Not Found
No
The description focuses on immunoassay technology and visual interpretation, with no mention of AI or ML.
No
Explanation: This device is a drug screening test used for detection, not for treating or preventing disease/conditions.
Yes
The device detects the presence of drugs of abuse in urine, which is a qualitative assessment used to identify a condition (drug use).
No
The device description clearly states it is an "Immunoassay" and a "kit" that uses "visual color sandwich one step immunoassay technology," indicating it is a physical test kit, not software.
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 of the following drugs of abuse in urine: Cocaine." This clearly indicates the device is used to examine a specimen (urine) obtained from the human body to provide information about a physiological state (presence of drugs).
- Device Description: The description states it's an "Immunoassay for the qualitative detection of benzoylecgonine in urine." Immunoassays performed on bodily fluids like urine are a common type of in vitro diagnostic test.
- Specimen Type: The device analyzes urine, which is a specimen taken from the human body.
- Purpose: The purpose is to detect the presence of drugs, which is a diagnostic or screening function performed outside of the body.
The fact that it's intended for home use by a lay user and includes a mechanism for confirmation at a certified laboratory further supports its classification as an IVD designed for a specific diagnostic purpose.
N/A
Intended Use / Indications for Use
The At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for this test is as follows: cocaine; 300 ng/ml. This assay is intended for use in the home to assist in preventing drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory.
A home drug screening, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection of the following drugs of abuse in urine: Cocaine.
Product codes
MVO
Device Description
Immunoassay for the qualitative detection of benzoylecgonine in urine. The At Home Drug Test, like many commercially available drug screening test kits, qualitatively measures the presence of target drug and metabolites by visual color sandwich one step immunoassay technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Correlation studies, using clinical specimens, produced a >99% 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 At Home Drug Test exhibited excellent overall accuracy (>98%) in the hands of professional users. A consumer study was also performed, in it the At Home Drug Test exhibited excellent overall accuracy. Consumer interpretation of the cocaine test showed accuracy to be 917/943 or 97.2%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
99% correlation (with Behring EMIT II and GC/MS methodology), >98% overall accuracy (professional users), 97.2% accuracy (consumer interpretation of cocaine test)
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
DEC 0 6 2001
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
Identification: At Home Drug Test (Model 9074)
Description: Immunoassay for the qualitative detection of benzoylecgonine in urine.
| Name Of Manufacturer: | Phamatech
.9530 Padgett Street,
Suite #101
San Diego, California 92126, USA |
| ----------------------- | -------------------------------------------------------------------------------------- |
|---|
Intended Use: The At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for this test is as follows: cocaine; 300 ng/ml. This assay is intended for use in the home to assist in preventing drug abuse. This kit is designed to incorporate a mechanism for anonymous confirmation testing to be performed at a SAMHSA certified laboratory.
The At Home Drug Test, like many commercially available drug screening test Technology: kits, qualitatively measures the presence of target drug and metabolites by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the ABMC (Ancramdale, NY) 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. Correlation studies, using clinical specimens, produced a >99% 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 At Home Drug Test exhibited excellent overall accuracy (>98%) in the hands of professional users. A consumer study was also performed, in it the At Home Drug Test exhibited excellent overall accuracy. Consumer interpretation of the cocaine test showed accuracy to be 917/943 or 97.2%
For the reasons mentioned above, it may be concluded that the Phamatech At Conclusion: 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.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 0 6 2001
Mr. Carl Mongiovi Vice President Phamatech, Inc. 9530 Padgett Street, Suite 101 San Diego, CA 92126
K013409 Re: Trade/Device Name: At Home Drug Test (Model 9074) Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and Cocaine Metablite Test System Regulatory Class: Class II Product Code: MVO Dated: November 15, 2001 Received: November 19, 2001
Dear Mr. Mongiovi:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 conninered pror to May 2017 3)
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). and Cosmetic 710- (110-) that to nevice, subject to the general controls provisions of the Act. The r ou may, diererey maxis of the Act include requirements for annual registration, listing of general controls proving practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elaboried to controls. Existing major regulations affecting your device can may be subject to back adders as a regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oe actived that i Dr over device complies with other requirements of the Act that I Dr Has intatutes and regulations administered by other Federal agencies. You must or any I caeral statutes and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quinny by of the every of (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -
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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 Sutman
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): _หุดเวนด9
Device Name: At Home Drug Test (Model 9074)
Indications for Use:
A home drug screening, and if needed, confirmation service. This kit provides a A none drug screening, and if noodou, committeen of the following drugs of abuse in urine: Cocaine.
Thomas C. Scott for Jeanne Cooper
(Division Sign-Off)
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: X