(176 days)
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.
This test is a one-step lateral flow chromatographic immunoassay.
Here's a breakdown of the acceptance criteria and study information for the Instant-View™ Marijuana (THC) Urine Dip Strip Test, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation of results with legally marketed test device (predicate device) > 98.8% | Higher than 98.8% |
| Overall agreement from accuracy evaluation (clinical lab & three physician's offices) | Greater than 95.9% |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "clinical laboratory & three physician's office laboratory" but does not give the number of samples tested in these settings.
- Data Provenance: Not explicitly stated (e.g., country of origin). The data appears to be from a clinical laboratory and three physician's office laboratories, implying real-world testing. It is implicitly retrospective as it compares with an existing legally marketed device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for this type of immunoassay is typically established by comparing the device's output to a confirmed analytical method (like GC/MS). Human experts are not used to establish the ground truth in this context, but rather to interpret the device's results.
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Adjudication method for the test set:
- Not applicable. This is a diagnostic device that provides a qualitative result. Adjudication methods like 2+1 are typically used for subjective assessments (e.g., image interpretation), not for objective test results.
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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 is a standalone diagnostic test (dip strip) and does not involve human readers interpreting complex cases or AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone device. The "accuracy evaluation from the clinical laboratory & three physician's office laboratory" assesses the device's performance directly against established methods, not in conjunction with human interpretation for performance enhancement. The interpretation of the dip strip (lines appearing or not) is a straightforward visual assessment by a healthcare professional, not an "algorithm" in the sense of AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth used for confirmation is alluded to: "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." This indicates that the true presence or absence of THC at the specified cutoff is determined by a highly accurate analytical method like GC/MS.
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The sample size for the training set:
- Not applicable. This type of immunoassay (dip strip) does not typically involve a "training set" in the machine learning sense. The device is designed and manufactured based on immunological principles, and its performance is validated through testing, not iterative training.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of this device. The device's inherent design for detecting THC at 50 ng/ml is based on established biochemical reactions, and its accuracy is verified through comparison with a gold standard analytical method on test samples.
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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 MSan Diego, CA 92121Telephone: (858) 350-9798Fax: (858) 350-9709Email: asdi@worldnet.att.net |
|---|---|
| Device Name | Trade Name: Instant-View™ Marijuana (THC) UrineDip Strip TestCommon Name: Cannabinoid TestClassification Name: 21 CFR 862.3870, Class II |
| Predicate Device | The Instant-View™ Marijuana (THC) Urine Dip Strip Testis substantially 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 Dip Strip Testis a qualitative immunoassay device intended to detect THC,a major 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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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.
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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 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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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)
§ 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).