(230 days)
Not Found
No
The description details a simple lateral flow immunoassay, which is a chemical test and does not involve AI/ML for its function. There are no mentions of AI, ML, or related concepts in the summary.
No.
This device is an immunoassay for detecting Methamphetamine in urine, which is a diagnostic tool, not a therapeutic one. It provides preliminary analytical results for drug screening.
Yes
The device is described as an "immunoassay device" intended "to be used to detect Methamphetamine in human urine," which provides a "preliminary analytical test result" for drug detection. This falls under the definition of a diagnostic device as it aims to identify a substance related to a medical condition (drug use).
No
The device description clearly indicates it is a "one-step lateral flow chromatographic immunoassay," which is a physical test strip, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is used to "detect Methamphetamine in human urine." This is a diagnostic test performed on a sample taken from the human body (urine) to provide information about a person's health status (presence of a drug).
- Device Description: It is described as a "one-step lateral flow chromatographic immunoassay." Immunoassays are a common type of test used in IVD devices to detect specific substances in biological samples.
- Anatomical Site: The test is performed on "human urine," which is a biological sample.
- Performance Studies: The document includes a summary of performance studies evaluating the test's correlation and accuracy, which are typical evaluations for IVD devices.
- Predicate Device: A predicate device is listed (K970395; QuikStrip One Step Methamphetamine Test), which is a legally marketed IVD device for a similar purpose. This further indicates that the device in question falls under the category of IVDs.
The definition of an IVD generally includes devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits this description.
N/A
Intended Use / Indications for Use
Instant-View™ Methamphetamine Urine Dip Strip Test is a qualitative immunoassay device intended to detect Methamphetamine in human urine at a cutoff level of 500 ng/ml. It is for health care professional use only.
Instant-View Methamphetamine Urine Dip Strip Test is a qualitative one step lateral flow,competitive binding immunoassay device intended to be used to detect Methamphetamine in human urine at a cutoff level of 500 ng/ml. It is intended for health care professional use only.
The US Substance Abuse and Mental Health Services Administration (SAMHSA) recommen the screening levels for Methamphetamine to be at a concentration.of 1000 ng/ml.
This 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
DJC
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 ™ . Methamphetamine Urine Dip Strip Test, and the legally marketed test device compared, is higher than 97.9%. The results from the three POL sites agreed 99.2%.
- The Accuracy evaluation results from Clinical Laboratory and the three Physician's Offices conducted by persons with diverse educational backgrounds and working experience agreed 95.2 % with the expected results.
- Based on the results of the Performance Characteristics and Comparison Studies, it may be concluded that the Instant-View™ Methamphetamine Urine Dip Strip Test is suitable for use by health care professionals with diverse educational backgrounds and work experiences, and it is substantially equivalent to the existing legally marketed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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
994406
Alfa Scientific Designs, Inc.
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™ Methamphetamine Urine Dip Strip Test
Common Name: Methamphetamine Test
Classification Name: 21 CFR 862.3610, Class II |
| Predicate Device | The Instant-View™ Methamphetamine 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 Methamphetamine Test, manufactured by Syntron Bioresearch, Inc. with 510(K) #: K970395, Date of Approval: 06/26/97. |
| Device Description | This test is a one-step lateral flow chromatographic immunoassay. |
| Intended Use | The Instant-View™ Methamphetamine Urine Dip Strip Test is a qualitative immunoassay device intended to detect Methamphetamine in human urine at a cutoff level of 500 ng/ml. It is for health care professional use only. |
| Summary of the
Similarities to the
Predicate Device | • Intended Use:
Both devices are intended to detect Methamphetamine in human urine at a cutoff level of 500 ng/ml.
• Interpretation of results:
The appearance of only one line - C line indicates a positive result, and that the Methamphetamine level is at a cutoff level of 500 ng ml or higher. And, the |
1
| Alfa Scientific Designs, Inc. | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------- |
appearance of two lines – both C line and T line indicates a negative result, and the Methamphetamine level is below 500 ng/ml.
· Technological Characteristics: Both devices are one step, qualitative, competitive binding immunoassav test, utilizing the basic immunochemical sandwich assay principle of recognition and formation of the specific Methamphetamine/Antibody/Methamphetamine complexes.
Discussion and Conclusion
- The correlation of results from the Instant-View ™ . Methamphetamine Urine Dip Strip Test, and the legally marketed test device compared, is higher than 97.9%. The results from the three POL sites agreed 99.2%.
- · The Accuracy evaluation results from Clinical Laboratory and the three Physician's Offices conducted by persons with diverse educational backgrounds and working experience agreed 95.2 % with the expected results.
- · Based on the results of the Performance Characteristics and Comparison Studies, it may be concluded that the Instant-View™ Methamphetamine Urine Dip Strip Test is suitable for use by health care professionals with diverse educational backgrounds and work experiences, and it is substantially equivalent to the existing legally marketed device.
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 or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
AUG 1 4 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Niashu Wang Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road, Suite M San Diego, California 92121
Re: K994406
Trade Name: Instant-View™ Methamphetamine Urine Dip Strip Test Regulatory Class: II Product Code: DJC Dated: July 7, 2000 Received: July 10, 2000
Dear Mr. Wang:
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.
3
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 regilation 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Toutman
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
4
of I Page 1
K994406 510(k) Number (if known):
Device Name: Instant-View Methamphetamine Urine Dip Strip Test
Indications For Use:
Instant-View Methamphetamine Urine Dip Strip Test is a qualitative one step lateral flow,competitive binding immunoassay device intended to be used to detect Methamphetamine in human urine at a cutoff level of 500 ng/ml. It is intended for health care professional use only.
The US Substance Abuse and Mental Health Services Administration (SAMHSA) recommen the screening levels for Methamphetamine to be at a concentration.of 1000 ng/ml.
This 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.
(Division Sign-Off)
Division of Clinical Laboratory Devices
$10(k) Number K994406
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)