(13 days)
#9145 25C, 9177 25C
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No
The device description and performance studies describe a standard immunoassay with visual interpretation and GC/MS confirmation, with no mention of AI or ML.
No
This device is for drug screening and detection, not for treating or preventing diseases or conditions.
Yes
The device provides a preliminary result for the detection/presence of drugs of abuse in urine, which assists in identifying a condition (drug use) in an individual. The text also mentions a "clinical sample correlation study," implying its use in a clinical context for diagnostic purposes, even if preliminary.
No
The device description clearly states it is a "rapid, qualitative immunoassay" and utilizes "visual color sandwich one step immunoassay technology," indicating it is a physical test kit with chemical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "A workplace drug screening and confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine." This clearly indicates the device is used to examine specimens derived from the human body (urine) to provide information for diagnostic purposes (detecting the presence of drugs).
- Device Description: The description states it's a "rapid, qualitative immunoassay for the detection of the target drugs/drug metabolites in urine." Immunoassays performed on bodily fluids like urine are a common type of in vitro diagnostic test.
- Performance Studies: The document describes performance studies using "clinical specimens" and comparing results to established methodologies like GC/MS and the Behring EMIT II, which are also IVD methods. This further supports its classification as an IVD.
The fact that it's used in a workplace setting and includes a mechanism for confirmation testing by GC/MS at a certified laboratory doesn't negate its classification as an IVD. The initial screening test itself is performed in vitro on a biological specimen to provide diagnostic information.
N/A
Intended Use / Indications for Use
At Work Drug 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: Phencyclidine (PCP); 25 ng/ml, amphetamine; 1000 ng/ml, cocaine; 300 ng/ml and opiates; #9145 25C at 300 ng/ml and 9177 25C at 2000 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.
A workplace drug screening and confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: Phencyclidine (PCP), Amphetamine, THC (marijuana), Cocaine and Opiates.
Product codes
LCL, DKZ, LDJ, DJG, DIO
Device Description
Immunoassay for the qualitative detection Phencyclidine (PCP), Amphetamine, THC, Cocaine and Opiates in urine
The At Work Drug Test, like many commercially available drug screening test Technology: kits, qualitatively measures the presence of target drugs or their 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
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Indicated Patient Age Range
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Intended User / Care Setting
workplace
GC/MS, to be performed at a certified laboratory.
professional users
lay user
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 Work 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 Work 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. 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 were also performed at two independent laboratories. In them the Phamatech At Work Drug Test™ 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 At Work 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
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N/A
0
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
At Work Drug Test (Model 9145 25C and 9177 25C) ldentification:
Description: Immunoassay for the qualitative detection Phencyclidine (PCP), Amphetamine, THC, Cocaine and Opiates in urine
Name Of Manufacturer:
Phamatech 9265 Activity Road #112 San Diego, California 92126, USA
Intended Use: At Work Drug 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: Phencyclidine (PCP); 25 ng/ml, amphetamine; 1000 ng/ml, cocaine; 300 ng/ml and opiates; #9145 25C at 300 ng/ml and 9177 25C at 2000 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 At Work Drug Test, like many commercially available drug screening test Technology: 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 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.
Performance: The product performance characteristics of the At Work 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 Work 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. 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 were also performed at two independent laboratories. In them the Phamatech At Work Drug Test™ 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 At Work 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%).
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech At Work 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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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 eagle or bird-like symbol with three curved strokes representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 6 1999
Mr. Carl A. Mongiovi Vice President of Operations Phamatech 9265 Activity Road Suite #112 San Diego. California 92126
Re: K994093
Trade Name: At Work Drug Test (Models 9145-25C and 9177-25C) Regulatory Class: II Product Code: LCL, DKZ, LDJ, DJG, DIO Dated: December 1, 1999 Received: December 3, 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 994097
Device Name: At Work Drug Test (Models 9145-25C and 9177-25C)
Indications for Use:
A workplace drug screening and confirmation service. This kit provides a preliminary result for the detection/presence of the following drugs of abuse in urine: Phencyclidine (PCP), Amphetamine, THC (marijuana), Cocaine and Opiates.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994093
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 801.109
V Over the Counter: