(52 days)
Not Found
Behring EMIT II
No
The summary describes a standard immunoassay test and does not mention any AI or ML components.
No
The device is a diagnostic test used for drug screening, not for treating a disease or condition.
No
The device is a home drug screening test that detects the presence of drugs in urine. While it provides an indication of drug use, it is not used for diagnosing a medical condition or disease. Its intended use is for "preventing drug abuse" and for "anonymous confirmation testing," not for medical diagnosis.
No
The device description clearly states it is a "rapid, qualitative immunoassay" and a "kit," indicating it includes physical components for performing a drug test on a urine sample. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "A home drug screening, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection of any of the following drugs of abuse in urine: Methamphetamine, MDMA." This clearly describes 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 a "rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine." Immunoassays performed on biological samples are a common type of IVD.
- Sample Type: The test is performed on urine, which is a biological specimen.
- Purpose: The purpose is to detect the presence of drugs of abuse, which is a diagnostic purpose.
The fact that it's intended for home use and includes a mechanism for confirmation testing at a certified laboratory further supports its classification as an IVD, specifically a home-use IVD.
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: Methamphetamine, MDMA; 500 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 nomic arage coroching, at a may of the following drugs of abuse in urine: Methamphetamine. MDMA.
Product codes
MVO
Device Description
Immunoassay for the qualitative detection of methamphetamine, MDMA in urine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urine
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. 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 methamphetamine test showed accuracy to be 428/444 or 96.4%
Key Metrics
96.4% accuracy for consumer interpretation of methamphetamine 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)
013412
Identification: At Home Drug Test (Model 9069)
Description: Immunoassay for the qualitative detection of methamphetamine, MDMA 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: Methamphetamine, MDMA; 500 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 methamphetamine test showed accuracy to be 428/444 or 96.4%
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 shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
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
Re: K013412
Trade/Device Name: At Home Drug Test (Model 9069) Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine 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 Section 310(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manative perice Americal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Device America commence prior to May 20, 1976, the exactions of the Federal Food. Drug, devices mat have occh recassinod in asses approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appl and Cosmetic Act (71ct) that to her request of the general controls provisions of the Act. The Tou may, dicierole, market the device, books of the mount registration, listing of gencial controls provisions of the revelop 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 classified (300 above) this. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FD may be subject to such additional controlier Litters, or Parts 800 to 898. In addition, FDA may be found in the Code of Peachar Regarning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuation of a succements.
that FDA has made a determination that your device complies with other requirements of the Act that IDA has made a actorinmation administered by other Federal agencies. You must of ally it catal statutes and regaranents ancluding, but not limited to: registration and listing (21 Comply with an the 70€ 31equirements, as and manufacturing practice requirements as set CTN Fart 807), ademig (21 CFR Part 800), and if applicable, the electronic forth in the quality systems (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 noutication. THE I Dr Intention 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 IT you desire specific acrices diagnostic devices), please contact the Office of Compliance at additionally 007.10 for mirrous and advertising on the promotion and advertising of your device, (301) 594-4500. Traditionally and (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 Information on your responsible in the sumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
3
K013412/5'
ម័រ ទី១/។ ប្រទេស
INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known): K013412
Device Name: At Home Drug Test (Model 9069)
Indications for Use:
A home drug screening, and if needed, confirmation service. This kit provides a A nomic arage coroching, at a may of the following drugs of abuse in urine: Methamphetamine. MDMA.
Shauws C. Muts for Jeave cooper
(Division Sign-Off)
vision of Clinical Laboratory Devices 510(k) Number
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 801.1099 Over the Counter:_