(176 days)
Not Found
No
The description details a standard lateral flow immunoassay, which is a chemical test, and does not mention any computational or algorithmic components indicative of AI/ML.
No.
The device is an immunoassay for detecting marijuana metabolites in urine, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.
Yes
This device detects a specific metabolite (11-nor-delta-9. THC-carboxylic acid) in human urine at a cutoff level, which is a diagnostic function to identify the presence of marijuana in the body. While it provides a preliminary result, it is used for the purpose of diagnosis.
No
The device description clearly states it is a "one-step lateral flow chromatographic immunoassay," which is a physical test strip, not software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The text explicitly states the device is "intended to be used to detect 11-nor-delta-9. THC-carboxylic acid (THC), a major metabolites of marijuana in human urine". This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about a physiological state (presence of THC metabolites).
- Device Description: The description of the device as a "one-step lateral flow chromatographic immunoassay" is consistent with the technology used in many IVD tests.
- Intended User / Care Setting: The indication for "health care professional use only" aligns with the typical use of IVD devices in a healthcare setting.
Therefore, the Instant-View Marijuana (THC) Urine Dip Strip Test fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Instant-View™ Marijuana (THC) Urine Dip Strip Test is a qualitative immunoassay device intended to detect THC, a major metabolite of marijuana, in human urine at a cutoff level of 50 ng/ml. It is intended for health care professional use only.
Instant-View Marijuana (THC) Urine Dip StripTest is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect 11-nor-delta-9. THC-carboxylic acid (THC), a major metabolites of marijuana in human urine at a cutoff level of 50 ng/ml. It is intended for health care professional use only.
The test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.
Product codes (comma separated list FDA assigned to the subject device)
LDJ
Device Description
This test is a one-step lateral flow chromatographic immunoassay.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professional use only
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The correlation of results from the Instant-View ™ Marijuana (THC) Urine Dip Strip Test, and the legally marketed test device compared, is higher than 98.8 %. The results of the accuracy evaluation from the clinical laboratory & three physician's office laboratory demonstrated an overall agreement of greater than 95.9 %.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
Not Found
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
§ 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
K99441°
11494 Sorrento Valley Road, Suite M San Diego, CA 92121
510(K) Summary
In accordance with the Safe Medical Devices Act of 1990, a 510(K) summary is provided as outlined in 21 CFR 807.92.
| Submitter | Name: Alfa Scientific Designs, Inc.
Address: 11494 Sorrento Valley Road, Suite M
San Diego, CA 92121
Telephone: (858) 350-9798
Fax: (858) 350-9709
Email: asdi@worldnet.att.net |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Trade Name: Instant-View™ Marijuana (THC) Urine
Dip Strip Test
Common Name: Cannabinoid Test
Classification Name: 21 CFR 862.3870, Class II |
| Predicate Device | The Instant-View™ Marijuana (THC) Urine Dip Strip Test
is substantially equivalent to other legally marketed devices
for the similar intended use. The device used for
comparison study is QuikStrip One Step Marijuana Test,
manufactured by Syntron Bioresearch, Inc. with 510(K) #:
K963654, Date of Approval: 02/28/97. |
| Device Description | This test is a one-step lateral flow chromatographic
immunoassay. |
| Intended Use | The Instant-View™ Marijuana (THC) Urine Dip Strip Test
is a qualitative immunoassay device intended to detect THC,
a major metabolite of marijuana, in human urine at a cutoff
level of 50 ng/ml. It is intended for health care professional
use only. |
| Summary of the
Similarities to the
Predicate Device | • Intended Use:
Both devices are intended to detect THC in human urine
at a cutoff level of 50 ng/ml.
• Interpretation of results:
The appearance of two lines - both C and T lines
Indicates a negative result. The THC level in the urine is
below 50 ng/ml. The absence of the T line indicates a |
1
11494 Sorrento Valley Road, Suite M Alfa Scientific Designs, Inc. San Diego, CA 92121 positive result, and the THC level in the urine is at a cutoff level of 50 ng/ml or higher. · Technological Characteristics: Both devices are one step, qualitative, competitive binding immunoassay test, utilizing the basic immunochemical sandwich assay principle of recognition and formation of the specific THC/Antibody/ THC complexes. · The correlation of results from the Instant-View ™ Discussion and Marijuana (THC) Urine Dip Strip Test, and the Conclusion legally marketed test device compared, is higher than 98.8 %. · The results of the accuracy evaluation from the clinical laboratory & three physician's office laboratory demonstrated an overall agreement of greater than 95.9 %. · Based on the results of the Performance Characteristics and Comparison Studies, it may be concluded that the Instant-View™ Marijuana (THC) Urine Dip Strip Test is suitable for professional use, and is substantially equivalent to the existing legally marketed product.
2
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.
JUN 2 1 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Rhoda Filipina OA Manager Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road Suite M San Diego, California 92121
K994410 Re:
Trade Name: Instant-View Marijuana (THC) Urine Dip Strip Test Regulatory Class: II Product Code: LDJ Dated: June 6, 2000 Received: June 8, 2000
Dear Ms. Filipina:
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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Page 2
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 packeted predicate device results in a classification for your device and thus, permits your drying 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 regulations entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other green 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) 443-6599 or at ins internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Routman
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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Page 1 of 1
K994410 510(k) Number (if known):
Instant-View Marijuana (THC) Urine Dip Strip Test Device Name:
Indications For Use:
Instant-View Marijuana (THC) Urine Dip StripTest is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect 11-nor-delta-9. THC-carboxylic acid (THC), a major metabolites of marijuana in human urine at a cutoff level of 50 ng/ml. It is intended for health care professional use only.
The test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.
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510(k) Number
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_V (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)