(52 days)
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No
The device description and performance studies focus on traditional immunoassay technology and visual interpretation, with no mention of AI or ML.
No.
This device is designed for detection and screening purposes and does not provide therapy or treatment.
Yes
The device is designed to detect the presence of specific drugs (Amphetamines) in urine, which is a qualitative assessment used to identify a condition (drug use) and guide subsequent actions (confirmation service).
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, and if needed, confirmation service. This kit provides a rapid, qualitative immunoassay for the detection/presence of the following drugs of abuse in urine: Amphetamines." This clearly describes a test performed in vitro (outside the body) 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 Amphetamines in urine." Immunoassays are a common type of IVD test.
- Sample Type: The test uses 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 by a lay user doesn't change its classification as an IVD. Many IVDs are designed for over-the-counter or home use.
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: Amphetamines; 1000 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 drug belooning, and intinention/presence of the following drugs of abuse in urine: Amphetamines.
Product codes (comma separated list FDA assigned to the subject device)
MVO
Device Description
Immunoassay for the qualitative detection of Amphetamines in urine.
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Urine
Indicated Patient Age Range
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Intended User / Care Setting
Home
Description of the training set, sample size, data source, and annotation protocol
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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 Amphetamine test showed accuracy to be 917/943 or 97.2%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation >99%
Overall accuracy >98% (professional users)
Accuracy 97.2% (consumer interpretation for Amphetamine test)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 9064)
Description: Immunoassay for the qualitative detection of Amphetamines 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: Amphetamines; 1000 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 Amphetamine 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 U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with outstretched arms, resembling an eagle or bird in flight. The figure is composed of three curved lines that create the impression of movement and dynamism. Encircling the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A.", arranged in a circular fashion.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Carl Mongiovi Vice President Phamatech, Inc. 9530 Padgett Street, Suite 101 San Diego, CA 92126
DEC 0 6 2001
Re: K013410
Trade/Device Name: At Home Drug Test (Model 9064) Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine 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 w one reveal above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for too batted in the 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may y aters or visions 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must corply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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. This i Dr I 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 If you desire spoolite an in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for m The craguestions on the promotion and advertising of your device, (301) 594-4566. Practionally, 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 montactor on your respondiations on 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
3
INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known): __ Koi3410
Device Name: At Home Drug Test (Model 9064)
Indications for Use:
A home drug screening, and if needed, confirmation service. This kit provides a A nomic drug belooning, and intinention/presence of the following drugs of abuse in urine: Amphetamines.
Thomas D. Rinta for Jeane Cooper
(Division Sign-Off)
ion of Clinical Laboratory Devices 510(k) Number _ 16013410
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