(157 days)
Not Found
No
The device description and intended use clearly describe a lateral flow immunoassay, which is a traditional chemical test and does not involve AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is an immunoassay intended to detect marijuana metabolites in human urine, which is a diagnostic purpose, not therapeutic.
Yes
This device is intended to detect a specific metabolite of marijuana in human urine, which provides a preliminary analytical test result for diagnostic purposes.
No
The device description clearly indicates it is a "lateral flow chromatographic immunoassay device," which is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for detecting a substance (THC metabolite) in a human sample (urine) to provide a preliminary analytical test result. This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: It describes a "lateral flow chromatographic immunoassay," which is a common type of in vitro diagnostic test.
- Anatomical Site: It specifies "human urine," which is a biological specimen.
- Intended User: It's intended for "health care professional use only," which is typical for many IVDs.
- Performance Studies: The document includes a summary of performance studies comparing it to a legally marketed test device and evaluating accuracy in clinical settings. This is a standard part of the regulatory process for IVDs.
- Predicate Device: It lists a predicate device with a K number (K963654), which indicates it was cleared through the FDA's 510(k) process, a common pathway for IVDs.
All these elements strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Instant-View™ Marijuana (THC) Urine Cassette 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 Test (Cassette) 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)
DKE
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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professional
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 ™ Discussion and Marijuana (THC) Urine Cassette Test, and the legally marketed test device compared, is higher than 96.7 %. The results of the accuracy evaluation from the clinical laboratory & three physician's office laboratory demonstrated an overall agreement of greater than 96.4 %.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
Alfa Scientific Designs, Inc.
11494 Sorrento Valley Road, Suite F&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 F&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
Cassette Test |
| | Common Name: Cannabinoid Test |
| | Classification Name: 21 CFR 862.3870, Class II |
| Predicate Device | The Instant-View™ Marijuana (THC) Urine Cassette 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 Cassette 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
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 Cassette Test, and the Conclusion legally marketed test device compared, is higher than 96.7 %. · The results of the accuracy evaluation from the clinical laboratory & three physician's office laboratory demonstrated an overall agreement of greater than 96.4 %. · Based on the results of the Performance Characteristics and Comparison Studies, it may be concluded that the Instant-View™ Marijuana (THC) Urine Cassette 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 stylized eagle with three lines representing its body and wings. The eagle is oriented to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN = 2 2000
Ms. Rhoda Filipina OA Manager Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road Suite M San Diego, California 92121
K994405 Re:
Trade Name: Instant-View Marijuana (THC) Urine Test (Cassette) Regulatory Class: II Product Code: DKE Dated: April 26, 2000 Received: April 28, 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 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" (21CFR 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/cdrls/dsmamain.html".
Sincerely yours,
Steven Routman
Steven 1. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page of of I
K994405 510(k) Number (if known):
Instant-View Marijuana (THC) Urine Test (Cassette) Device Name:
Indications For Use:
Instant-View Marijuana (THC) Urine Test (Cassette) 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.
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994405
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
prescription
OTC
(Optional Format 3-10-98)