(80 days)
Not Found
Behring EMIT II (Cupertino, CA 95014), GC/MS methodology
No
The description focuses on immunoassay technology and standard performance studies, with no mention of AI or ML terms or concepts.
No.
This device is designed for drug screening and detection, not for treating or preventing a disease or condition.
Yes
The device is described as a "home drug screening" kit that provides "a preliminary result for the detection/presence of the following drugs of abuse in urine," which directly falls under the definition of diagnosing a condition or the presence of specific substances in the body.
No
The device description clearly indicates it is an immunoassay kit for detecting drugs in urine, which is a hardware-based test, not software.
Based on the provided information, 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 preliminary result for the detection/presence of the following drugs of abuse in urine: amphetamine, cocaine, methamphetamine, opiates, PCP and THC". 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 device is described as an "Immunoassay for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP and THC in urine." Immunoassays are a common type of in vitro diagnostic test.
- Sample Type: The test is performed on urine, which is a biological specimen.
- Performance Studies: The document describes performance studies using clinical samples and spiked samples, which are typical for evaluating the accuracy and reliability of IVD devices.
The fact that it's intended for home use and provides a preliminary result doesn't change its classification as an IVD. IVDs can be used in various settings, including at home.
N/A
Intended Use / Indications for Use
The QuickScreen™ At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for these tests is as follows: amphetamine; 1000 ng/ml, cocaine; 300 ng/ml, methamphetamine; 500 ng/ml, opiates; 300 ng/ml, PCP; 25 ng/ml and THC; 50 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 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: amphetamine, cocaine, methamphetamine, opiates, PCP and THC
Product codes (comma separated list FDA assigned to the subject device)
MVO
Device Description
Immunoassay for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP and THC in urine.
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
The product performance characteristics of the QuickScreen™ At Home Performance; Drug Test were evaluated in a clinical sample correlation study and a blind labeled spiked study.
Correlations 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.
A consumer study was also performed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of these studies demonstrate the Phamatech QuickScreen™ 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 >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 QuickScreen™ exhibited excellent overall accuracy (>98%) in the hands of professional users.
A consumer study was also performed., in it the QuickScreen™ At Home Drug Test exhibited excellent overall accuracy (>96%) in the hands of lay users.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
99% correlation, >98% overall accuracy, >96% overall accuracy
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.
The ABMC (Ancramdale, NY) and the Applied Biotech SureStep Test (San Diego, CA 92121)
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.
Behring EMIT II (Cupertino, CA 95014) and GC/MS methodology
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
OCT 1 6 1998
610 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
QuickScreen™ At Home Drug Test (Model 9149 and 9150) ldentification:
Description: Immunoassay for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP and THC in urine.
Name Of Manufacturer:
Phamatech 9265 Activity Road #112 San Diego, California 92126, USA
Intended Use: The QuickScreen™ At Home Drug Screening Test is a rapid, qualitative immunoassay for the detection of target drugs/metabolites in urine. The cut-off concentration for these tests is as follows: amphetamine; 1000 ng/ml, cocaine; 300 ng/ml, methamphetamine; 500 ng/ml, opiates; 300 ng/ml, PCP; 25 ng/ml and THC; 50 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 certified laboratory.
Technology: The QuickScreen™ 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. 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 QuickScreen™ At Home Performance; Drug Test were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the Phamatech QuickScreen™ 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 >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 QuickScreen™ exhibited excellent overall accuracy (>98%) in the hands of professional users. A consumer study was also performed., in it the QuickScreen™ At Home Drug Test exhibited excellent overall accuracy (>96%) in the hands of lay users.
For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech QuickScreen™ At 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.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 16 1998
Carl Mongiovi Director of Operations Phamatech 9265 Activity Road #112/113 San Diego, California 92126
K982621 Re : QuickScreen™ At Home Drug Test Requlatory Class: II Product Code: MVO Dated: July 24, 1998 Received: July 28, 1998
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 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 Requlations, 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 General regulation (21 CFR Part 820) and that, Devices: 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 requlations.
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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 requlation (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/dsmamain.html".
Sincerely yours,
Steven Gutman
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): _ K982621
Device Name: QuickScreen™ At Home Drug Test
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: amphetamine, cocaine, methamphetamine, opiates, PCP and THC
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of the CDRH Office of Device Evaluation (ODE)
emonts
Division Sign-Off)
vision of Clinical Laboratory Devices
0(k) Number. K982621
Division Sign-off
Division of Clinical Laboratory Devices
510 (k) Number
| Prescription Use: | |
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| Per 21 CFR 801.109 |
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