(88 days)
Phamatech At Home™ DrugTest, Phamatech QuickScreen Pro Multi Drug Screening Test
Not Found
No
The device description and performance studies indicate a visual color immunoassay technology, with no mention of AI or ML.
No.
This device is an in vitro diagnostic test used for the qualitative identification of drugs in urine for the diagnosis of drug abuse, not for treating any condition.
Yes
This device is explicitly described as "An in vitro diagnostic test" in its "Intended Use / Indications for Use" section, and states that its measurements "are used in the diagnosis of drug abuse."
No
The device description clearly states it is an immunoassay test 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/Indications for Use: The description explicitly states it is an "in vitro diagnostic test" and that the measurements are "used in the diagnosis of drug abuse." This directly aligns with the definition of an IVD, which is a medical device used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description further clarifies it's an "Immunoassay for the qualitative detection... in urine." Immunoassays performed on bodily fluids like urine are a common type of IVD.
- Performance Studies: The performance studies describe evaluating the device using "clinical specimens," which are samples taken from patients, a key characteristic of IVD testing.
The fact that it's intended for "professional use only" and uses a "visual color sandwich one step immunoassay technology" further supports its classification as a professional-use IVD.
N/A
Intended Use / Indications for Use
Phamatech QuickScreen™ Model 9177X & 9178X is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentrations of this test are as follows: amphetamine; 1000 ng/ml, THC; 50 ng/ml, cocaine; 300 ng/ml, PCP 25 ng/ml, opiates; 2000 ng/ml, methamphetamines; 500 ng/ml. This assay is intended to assist in the prevention of drug abuse
An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, opiates, PCP and THO in anno. Theasurement of the intended for professional use only.
An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, opiates, methamphetaminoo and 1110 in annot abuse. It is intended for professional use only.
Product codes
LCM, DKZ, DJC, DIO, DJG, LDJ
Device Description
Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, Opiates and PCP (9177X) or Methamphetamines (9178X) in urine.
The Phamatech QuickScreen™ Model 9177X & 9178X, 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.
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
professional use only.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The product performance characteristics of the Phamatech QuickScreen™ Models 9177X & 9178X was evaluated in a clinical sample correlation. The results of these studies demonstrate the Phamatech QuickScreen™ Model 9177X & 9178X 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 >98% correlation when compared to the QuickScreen™ in the hands of professional users.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
98% correlation
Predicate Device(s)
Phamatech At Home™ DrugTest, Phamatech QuickScreen Pro Multi Drug Screening Test
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
SEP 1 0 2004
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
Phamatech QuickScreen™ Models 9177X and 9178X ldentification:
Description: Immunoassay for the qualitative detection, Amphetamine, THC, Cocaine, Opiates and PCP (9177X) or Methamphetamines (9178X) in urine.
| Name Of Manufacturer: | Phamatech, Inc.
10151 Barnes Canyon Road
San Diego, California 92121, USA |
| ----------------------- | --------------------------------------------------------------------------------- |
|---|
Intended Use: Phamatech QuickScreen™ Model 9177X & 9178X is a rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine. The cut-off concentrations of this test are as follows: amphetamine; 1000 ng/ml, THC; 50 ng/ml, cocaine; 300 ng/ml, PCP 25 ng/ml, opiates; 2000 ng/ml, methamphetamines; 500 ng/ml. This assay is intended to assist in the prevention of drug abuse
The Phamatech QuickScreen™ Model 9177X & 9178X, like many Technology: commercially available drug screening test 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 Phamatech At Home™ DrugTest and the Phamatech QuickScreen Pro Multi Drug Screening Test. 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 Phamatech Performance: QuickScreen™ Models 9177X & 9178X was evaluated in a clinical sample correlation. The results of these studies demonstrate the Phamatech QuickScreen™ Model 9177X & 9178X 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 >98% correlation when compared to the QuickScreen™ in the hands of professional users.
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickScreen™ Model 9177X & 9178X is substantially equivalent to a variety of detection tests currently in commercial distribution and is safe in the hands of the professional user.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 0 2004
Mr. Carl A. Mongiovi Vice President Phamatech 10151 Barnes Canyon Road San Diego, CA 92121
K041578 Re:
Trade/Device Name: Phamatech QuickScreen™ Model 9177X Phamatech QuickScreem™ Model 9178X Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: LCM, DKZ, DJC, DIO, DJG, LDJ Dated: July 28, 2004 Received: September 2, 2004
Dear Mr. Mongiovi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced 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 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) 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 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Seain M. Cooper, US, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known): _K_04 | 5 78
Device Name:_Phamatech QuickScreen™ Model 9177X
Indications for Use:
An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, An in vitro diagnostic test for the qualifative faction in this device are used in the oplates, FCP and THO in anno. Theaturement of the intended for professional use only.
Prescription Use:_____________________________________________________________________________________________________________________________________________________________ 1 (Part 21 CFR 801 Subpart D
AND/OR
Over the Counter Use: (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
RH Office of In Vitro Diagnostic Devices (OIVD) Concurrence of the
Allerto Serta
Division Sign-Off
Division Sign-l
Office of In Vitro Diagnostic Device Evaluation and
510(k)
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INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known): _KO4 1578
Device Name: Phamatech QuickScreen™ Model 9178X
Indications for Use:
An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, An if vitro diagnostic tool for the quantatione. Measurements obtained by this device opiates, methamphetaminoo and 1110 in annot abuse. It is intended for professional use only.
1 Prescription Use: (Part 21 CFR 801 Subpart D Over the Counter Use: (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
| Concurrence of the Office of In Vitro Diagnostic Devices (OIVD) |
|---|
| Division Sign-Off |
Office of In Vitro Diagnostic
Device Evaluation and Safety
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AND/OR
510(k) K041578
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