(57 days)
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No
The summary describes a standard immunoassay drug screening test and does not mention any AI or ML components.
No
The device is described as a drug screening kit for detecting the presence of drugs of abuse in urine, which is a diagnostic tool, not a therapeutic intervention.
Yes
Explanation: The device provides a preliminary result for the detection/presence of drugs of abuse in urine, which is a diagnostic function. It identifies a condition (presence of drugs) in a sample.
No
The device description clearly indicates it is an immunoassay kit for detecting drugs in urine, which is a hardware-based test.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "A workplace drug screening... for the detection/presence of the following drugs of abuse in urine." This clearly indicates testing biological samples (urine) outside of the body to gain information about a person's health or condition (in this case, the presence of drugs).
- Device Description: The description states "Immunoassay for the qualitative detection... in urine." Immunoassays are a common type of IVD test that uses antibodies to detect specific substances in biological samples.
- Performance Studies: The document describes performance studies using "clinical sample correlation study and a blind labeled spiked study" and "clinical specimens." These studies are typical for evaluating the performance of IVD devices.
- Predicate and Reference Devices: The mention of predicate and reference devices (Phamatech QuickScreen At Home Drug Test, Phamatech QuickScreen Pro Multi Drug ScreeningTest, Behring EMIT II) further supports that this device falls within the category of IVDs, as these are likely other drug screening IVDs.
The core function of the device is to analyze a biological sample (urine) in vitro (outside the body) to provide diagnostic information (the presence of drugs). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A workplace 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: Methamphetamine, Amphetamine, THC, Cocaine and Opiates
Product codes
LAF, DKZ, LDJ, DIO, DJG
Device Description
Immunoassay for the qualitative detection Methamphetamine. THC. Cocaine and Opiates in urine
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
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Indicated Patient Age Range
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Intended User / Care Setting
workplace
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
The product performance characteristics of the QuickScreen Workplace Drug Screening Test were evaluated in a clinical sample correlation study and a blind labeled spiked study. Correlations studies, using clinical specimens, produced a >98% 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of these studies demonstrate the Phamatech QuickScreen Workplace Drug Screening 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. In them the Phamatech QuickScreen™ exhibited excellent overall accuracy (>97%) in the hands of professional users. A comsumer study using the At Home Drug Test, which utilizes identical formulation and, like the QuickScreen Workplace Drug Screening Test, includes GC/MS confirmation testing as a component, was performed. In the hands of lay users the test exhibited excellent overall accuracy (>96.4%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
98% correlation, >97% overall accuracy, >96.4% overall accuracy
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
OCT 6 1999
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
QuickScreen Workplace Drug Screening Test (Model 9147 25C) ldentification:
Description: Immunoassay for the qualitative detection Methamphetamine. THC. Cocaine and Opiates in urine
Name Of Manufacturer:
Phamatech 9265 Activity Road #112 San Diego, California 92126, USA
Intended Use: QuickScreen Workplace Drug Screening Test 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: methamphetamine: 500 ng/ml. amphetamine: 1000 ng/ml. cocaine: 300 ng/ml and opiates; 300 ng/ml. This assay is intended for use in the workplace assist in the prevention of drug abuse. This kit, as supplied, incorporates a mechanism for confirmation testing by GC/MS, to be performed at a certified laboratory.
The QuickScreen Workplace Drug Screening Test, like many commercially available Technology: 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 QuickScreen At Home Drug Test and the Phamatech QuickScreen Pro Multi Drug ScreeningTest. 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 Workplace Drug Performance: Screening Test were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the Phamatech QuickScreen Workplace Drug Screening 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 >98% 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 (>97%) in the hands of professional users.
A comsumer study using the At Home Drug Test, which utilizes identical formulation and, like the QuickScreen Workplace Drug Screening Test, includes GC/MS confirmation testing as a component, was performed. In the hands of lay users the test exhibited excellent overall accuracy (>96.4%).
For the reasons mentioned above, it may be concluded that the Conclusion: Phamatech QuickScreen Workplace Drug Screening 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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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure with three wavy lines extending from the figure's head, resembling a bird in flight.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 6 1999
Mr. Carl A. Mongiovi Vice President of Operations Phamatech 9265 Activity Road Suite #112 San Diego, California 92126
Re: K992685
Trade Name: QuickScreen Pro Multi Drug Screening Test (Model 9147) Regulatory Class: II Product Code: LAF, DKZ, LDJ, DIO, DJG Dated: September 13, 1999 Received: September 13, 1999
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 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). 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 Regulations, 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 Devices: General regulation (21 CFR Part 820) and that, 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 regulations.
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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 regulation (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/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): _K 9 92(g85
Device Name: QuickScreen Workplace Drug Screening Test (Model 9147 25C)
Indications for Use:
A workplace 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: Methamphetamine, Amphetamine, THC, Cocaine and Opiates
P.Bernlavet for g.Cooper DVM
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number IS 997685
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 Over the Counter:
OR