(117 days)
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No
The device description details a traditional immunoassay based on competitive binding and colorimetric detection, with no mention of AI or ML components.
No
The device is described as a "Drug Detection Device" for initial screening of marijuana metabolites in urine, and the intended use states it is "not intended to be used in monitoring cannabinoid levels." It is a diagnostic tool, not a treatment.
Yes
This device is a rapid, qualitative immunoassay for the determination of Cannabinoids and its metabolites in urine, providing preliminary data for drug detection. This falls under the definition of a diagnostic device as it is used to identify the presence of a specific condition (presence of marijuana metabolites).
No
The device description clearly states it is a "chromatographic absorbent device" and describes a physical process involving a porous membrane support and antibody-dye conjugate, indicating it is a hardware-based test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "determination of Cannabinoids and its metabolites in urine." Urine is a biological specimen, and the test is performed in vitro (outside the body).
- Device Description: The description details a "chromatographic absorbent device" that tests "urine for the presence of Marijuana and its metabolites." This further confirms the in vitro nature of the test.
- Classification: The device is classified as a "class II device per 21 CFR 862.3870," which is the regulation for Cannabinoid Test Systems. This classification falls under the umbrella of IVDs.
- Testing Method: The description of the test mechanism (immunoassay, competition for antibody sites) is characteristic of many IVD tests.
- Performance Studies: The performance studies involve testing "individual urine samples" and comparing results to reference methods like GC/MS, which are standard practices for evaluating IVD performance.
All these points clearly indicate that the device is designed to perform a diagnostic test on a biological sample outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Drug Detection Devices Marijuana Test is a rapid, qualitative, competitive binding immunoassay for the determination of Cannabinoids and its metabolites in urine. The test provides only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. This test is not intended to be used in monitoring cannabinoid levels.
Product codes
LDJ
Device Description
Drug Detection Devices Marijuana test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a rose-pink color band when the detection level of 50 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a rose-pink color band, demonstrating that the reagents and device are functioning correctly.
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
medical/forensic screening of urine.
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 final product has been subjected to both in house testing of 261 individual urine samples using both the Syva Emit and GC/MS against the new product. Subsequently the device was subjected to a broader clinical trial in a NIDA certified laboratory where the calculated sensitivity equaled 0.993, the specificity equaled 1.00 and the calculated accuracy equaled 99.67% when compared to the gold standard of GC/MS.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The final product has been subjected to both in house testing of 261 individual urine samples using both the Syva Emit and GC/MS against the new product. The calculated sensitivity was 0.9801 and specificity was found to be 0.9636 with the accuracy of 97.32%. Subsequently the device was subjected to a broader clinical trial in a NIDA certified laboratory where the calculated sensitivity equaled 0.993, the specificity equaled 1.00 and the calculated accuracy equaled 99.67% when compared to the gold standard of GC/MS. Statistical comparisons of all possible combinations of reference methods to the experimental new device failed to identify any significant difference between the reference method and the Drug Detection Devices method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The calculated sensitivity was 0.9801 and specificity was found to be 0.9636 with the accuracy of 97.32%. The calculated sensitivity equaled 0.993, the specificity equaled 1.00 and the calculated accuracy equaled 99.67%.
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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§ 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).
0
Image /page/0/Picture/3 description: The image shows the text "3D Ltd" in a bold, stylized font. The "3D" is stacked on top of "Ltd", with the "3" being smaller than the "D". The text is black and appears to be slightly distressed or aged, giving it a vintage or retro look.
510k Submission for DrugScreen Dip Marijuana Test SCREENERS Marijuana Test
DEC 27 1999
Summary of Safety and Effectiveness 10.
The sponsor Drug Detection Devices Ltd. (6620 Meadowridge Court, Suite A-7, Alpharetta, GA 30005) has had developed and tested under GMP/GLP guidelines a device for the qualitative testing of urine for the presence of Marijuana and its metabolites in a screening format.
The Trade names of the device are SCREENERS Marijuana Test and DrugScreen Dip Marijuana Test, having a designated common name of Cannabinoid Test System and a classification as a class II device per 21 CFR 862.3870. This device is intended for medical/forensic screening of urine.
Drug Detection Devices Marijuana test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a rose-pink color band when the detection level of 50 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a rose-pink color band, demonstrating that the reagents and device are functioning correctly.
The final product has been subjected to both in house testing of 261 individual unne samples using both the Syva Emit and GC/MS against the new product. The calculated sensitivity was 0.9801 and specificity was found to be 0.9636 with the accuracy of 97.32%. Subsequently the device was subjectic to a broader clinical trial in a NIDA certified laboratory where the calculated sensitivity equaled 0,993, the specificity equaled 1.00 and the calculated accuracy equaled 99.67% when compared to the gold standard of GC/MS, Statistical comparisons of all possible combinations of reference methods to the experimental new device failed to identify any significant difference between the reference method and the Drug Detection Devices method.
Additional information on this submission may be obtained by contacting Bruce Christie, CEO of Drug Detection Devices, Ltd. at 770-886-6226 or by fax at 770-886-7792.
PROPRIETARY INFORMATION
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle. The eagle is depicted with three lines forming its body and three curved lines representing its tail feathers.
DEC 27 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Bruce Christie Chief Executive Officer Drug Detection Devices, Ltd. 6820 Meadowridge Court Suite A-7 Alpharette, Georgia 30005
Re: K992949 Trade Name: SCREENERS™ Marijuana Test DrugScreen™ Dip Marijuana Test Regulatory Class: II Product Code: LDJ Dated: November 22, 1999 Received: November 24, 1999
Dear Mr. Christie:
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 vours.
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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510(k) Number (if Known): To Be Assigned / 992149
DrugScreen™ Dip Marijuana Test Device Names: SCREENERS™ Marijuana Test
Indications For Use:
The Drug Detection Devices Marijuana Test is a rapid, qualitative, competitive binding immunoassay for the determination of Cannabinoids and its metabolites in urine. The test provides only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. This test is not intended to be used in monitoring cannabinoid levels.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANDOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Levices ag god g 510(k) Number
Prescription Use: / or
(Per 21 CFR 801.109
Over The Counter Use: (Optional Format 1-2-96)