(36 days)
LDJ
Syva EMIT II
No
The description details a standard immunoassay test kit that relies on visual color changes and colloidal gold labeling, with no mention of AI, ML, or any computational analysis beyond basic performance metrics.
No
This device is an in-vitro diagnostic test used for identifying tetrahydrocannabinoid in urine, which aids in diagnosis and treatment, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements obtained by this device are "used in the diagnosis and treatment of marijuana use or overdose."
No
The device description clearly states it is an in-vitro diagnostic test kit utilizing colloidal gold and immunoassay technology, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's an "in-vitro diagnostic test for the qualitative identification of tetrahydrocannabinoid, in urine." It also mentions that the measurements are used in the "diagnosis and treatment of marijuana use or overdose." This clearly indicates it's used to test samples taken from the body (in vitro) to provide information for diagnosis and treatment.
- Device Description: The description details a test that utilizes a chemical reaction (immunoassay with colloidal gold) to detect a substance in a biological sample (urine). This is a hallmark of IVD devices.
- Sample Type: The test is performed on urine, which is a biological sample taken from the body.
- Purpose: The purpose is to identify the presence of a substance (THC) in the sample to aid in diagnosis and treatment.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of Tetrahydrocannabinoid (THC), a hallucinogenic compound and principle active component in marijuana, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of marijuana use.
Product codes
LDJ
Device Description
Immunoassay for the Qualitative Detection of Tetrahydrocannabinoid in Urine
The QuickScreenTM One Step THC Screening Test utilizes colloidal gold as the label like other commercially available immunoassays for drug of abuse test kits, to qualitatively measure for the presence of THC 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
clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies
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
The product performance characteristics of the QuickScreen™ One Step THC Screening Test was evaluated in a clinical sample correlation study and a blind labeled THC study. The results of these studies demonstrate the Phamatech QuickScreen™ One Step THC Screening Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of Cocaine in urine.
Key Metrics
Sensitivity of greater than 98%, a specificity of greater than 98% and accuracy greater than 99%
Predicate Device(s)
ABI SureStep, Syntron Bioresearch THC Test
Reference Device(s)
Syva EMIT II
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
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SEP 2 5 1997
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
Identification: OuickScreen TM One Step THC Screening Test (9075)
Immunoassay for the Qualitative Detection of Tetrahydrocannabinoid in Description: Urine
Name Of Manufacturer:
Phamatech 9265 Activity Road #112 / 113 San Diego, California 92126, USA
Intended Use: A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of tetrahydrocannabinoid, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of marijuana use or overdose
Technology: The QuickScreenTM One Step THC Screening Test utilizes colloidal gold as the label like other commercially available immunoassays for drug of abuse test kits, to qualitatively measure for the presence of THC by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the ABI SureStep (San Diego, CA 92121)and the Syntron Bioresearch THC Test (Vista, CA 92083). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / THC / antibody / complexes.
Performance: The product performance characteristics of the QuickScreen™ One Step THC Screening Test was evaluated in a clinical sample correlation study and a blind labeled THC study. The results of these studies demonstrate the Phamatech QuickScreen™ One Step THC Screening Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of Cocaine in urine.
Correlation studies, using clinical specimens, produced a sensitivity of greater than 98%, a specificity of greater than 98% and accuracy greater than 99% when compared to the Syva EMIT II (San Jose, CA 95161).
Two independent clinical laboratories conducted studies which demonstrated the Phamatech OuickScreen™ exhibited excellent performance in the hands of professional laboratory technicians.
For the reasons mentioned above, it may be concluded that the Phamatech Conclusion: QuickScreenTM One Step THC ScreeningTest is substantially equivalent to a variety of qualitative THC screening tests currently in commercial distribution.
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SEP 2 5 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Tuan H. Pham . President Phamatech, Inc. 9265 Activity Road, Suite 112-113 San Diego, California 92126
Re : K973122 QuickScreen™ One Step THC Test Requlatory Class: II Product Code: LDJ August 20, 1997 Dated: Received: Auqust 20, 1997
Dear Tuan H. Pham:
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, Druq, 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. ਸੀ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. 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 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.qov/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
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INDICATIONS FOR USE
Applicant: Phamatech
510(k) Number (if known): __
Device Name: QuickScreen TM One Step THC Screening Test
Indications for Use:
A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an invitro diagnostic test for the qualitative identification of Tetrahydrocannabinoid (THC), a hallucinogenic compound and principle active component in marijuana, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of marijuana use.
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. R973/22
Division Sign-Off Division of Clinical Laboratory Devices 510(k) Number:
Prescription Use:
Per 21 CFR 801.109
OR Over the Counter _____________________________________________________________________________________________________________________________________________________________