(157 days)
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.
This test is a one-step lateral flow chromatographic immunoassay.
Here's an analysis of the provided text regarding the Alfa Scientific Designs, Inc. Instant-View™ Marijuana (THC) Urine Cassette Test, structured to address your specific questions:
The provided text focuses on the 510(k) submission for a diagnostic device. It describes the device, its intended use, and claims substantial equivalence to a predicate device based on performance characteristics.
Acceptance Criteria and Device Performance Summary
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Correlation with Predicate Device | "higher than 96.7 %" (Implied minimum for substantial equivalence to predicate) | "higher than 96.7 %" |
| Overall Agreement (Accuracy) | "greater than 96.4 %" (Implied minimum for substantial equivalence) | "greater than 96.4 %" (based on clinical laboratory and P.O.L. evaluation) |
Note: The document implies the "acceptance criteria" through statements of achievement for substantial equivalence. Explicit criteria values are not provided as a separate list but rather as the achieved performance which was deemed acceptable.
Study Details
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the total number of samples used in the accuracy evaluation. It mentions "results of the accuracy evaluation from the clinical laboratory & three physician's office laboratory," suggesting multiple sites contributed data, but the specific number of cases tested is not provided.
- Data Provenance: The document does not specify the country of origin of the data. It indicates the data came from a "clinical laboratory" and "three physician's office laboratory," suggesting a prospective clinical evaluation, but it doesn't explicitly state "retrospective" or "prospective." Given that accuracy was evaluated, it's highly likely to be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "experts" and "ground truth" in the context of identifying THC in urine typically refers to a reference method, not individual human interpreters for diagnostic readings.
- The ground truth in this case is established by the predicate device (QuikStrip One Step Marijuana Test, manufactured by Syntron Bioresearch, Inc.) and a more specific alternate chemical method for confirmation.
- The document explicitly states: "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."
- Therefore, the "experts" are the analytical instruments and validated methodologies of a clinical laboratory, not human readers assessing images or clinical findings.
4. Adjudication Method for the Test Set
Not applicable in this context. Adjudication methods like 2+1 or 3+1 typically apply to studies where multiple human readers independently interpret results and discrepancies need to be resolved. For a qualitative, competitive binding immunoassay like this, the "reading" is typically objective (presence/absence of a line) and compared against a reference method (GC/MS or the predicate device). Discrepancies would involve retesting or review by laboratory personnel following standard operating procedures, rather than an "adjudication committee."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a standalone in-vitro diagnostic assay for detecting a substance in urine, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers in the primary diagnostic step.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence, a "standalone" performance evaluation was conducted. The device itself (the cassette test) produces a result (presence or absence of a line) which is then interpreted by a healthcare professional. The performance metrics (correlation and agreement) are for the device's ability to accurately detect THC compared to a reference standard, independent of human interpretive variability beyond simply reading the lines according to instructions. The device essentially is the "algorithm" in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The primary ground truth described for confirmation is Gas Chromatography/Mass Spectrophotometry (GC/MS), which is an analytical gold standard for substance identification and quantification. For the broader comparison, the predicate device's results served as a comparative ground truth.
8. The Sample Size for the Training Set
Not applicable. This is an immunoassay device, not a machine learning or AI model that requires a "training set." Its performance is based on the chemical and biological interactions built into the test strip.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device.
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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&MSan Diego, CA 92121Telephone: (858) 350-9798Fax: (858) 350-9709Email: asdi@worldnet.att.net |
|---|---|
| Device Name | Trade Name: Instant-View™ Marijuana (THC) UrineCassette Test |
| Common Name: Cannabinoid Test | |
| Classification Name: 21 CFR 862.3870, Class II | |
| Predicate Device | The Instant-View™ Marijuana (THC) Urine Cassette Test issubstantially equivalent to other legally marketed devicesfor the similar intended use. The device used forcomparison 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 chromatographicimmunoassay. |
| Intended Use | The Instant-View™ Marijuana (THC) Urine Cassette Test isa qualitative immunoassay device intended to detect THC, amajor metabolite of marijuana, in human urine at a cutofflevel of 50 ng/ml. It is intended for health care professionaluse only. |
| Summary of theSimilarities to thePredicate Device | • Intended Use:Both devices are intended to detect THC in human urineat a cutoff level of 50 ng/ml.• Interpretation of results:The appearance of two lines - both C and T linesIndicates a negative result. The THC level in the urine isbelow 50 ng/ml. The absence of the T line indicates a |
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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.
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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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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
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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)
§ 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).