(220 days)
Not Found
No
The device description and performance studies describe a standard lateral flow immunoassay, with no mention of AI or ML technology.
No
This device is a diagnostic test used to detect methamphetamine in urine, not to treat a condition.
Yes
Explanation: The device is intended to detect methamphetamine in human urine, providing 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 / Indications for Use" section explicitly states that the device is "intended to be used to detect methamphetamine in human urine". This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to diagnose or detect a condition (presence of methamphetamine).
- Device Description: The description of the device as a "one-step lateral flow chromatographic immunoassay" further supports its classification as an IVD. Immunoassays are common techniques used in IVD tests to detect specific substances in biological samples.
- Sample Type: The test uses "human urine" as the sample, which is a biological specimen analyzed in vitro.
- Purpose: The purpose is to "detect methamphetamine", which is a substance indicative of drug use, a condition that can be diagnosed or monitored through in vitro testing.
The fact that it's for "health care professional use only" and provides a "preliminary analytical test result" that requires confirmation by another method (like GC/MS) is also consistent with many IVD devices used in clinical settings.
N/A
Intended Use / Indications for Use
The Instant-View™ Methamphetamine Urine Cassette Test is a qualitative immunoassay device intended to detect methamphetamine in human urine at a cutoff level of 500 ng/ml. It is intended for health care professional use only.
Instant-View Methamphetamine Urine Cassette 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) recommends 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. Professional judgment should be applied to any drug of abuse, Chilled Consideration and positive results are used.
Product codes (comma separated list FDA assigned to the subject device)
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 Cassette Test, is higher than 97.5 %. The results from all three POL sites agreed 98.3 %.
The Accuracy Evaluation results from the Clinical Laboratory conducted by persons with diverse educational background and working experiences agreed 95.2% with the expected results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation of results from the Instant-View™ Methamphetamine Urine Cassette Test: higher than 97.5 %.
Agreement of results from all three POL sites: 98.3 %.
Accuracy Evaluation results from Clinical Laboratory: 95.2% agreement with expected results.
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
§ 862.3610 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
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 |
| Cassette Test | ||
| Common Name: | Methamphetamine Test | |
| Classification Name: | 21 CFR 862.3610, Class II | |
| Predicate Device | The Instant-View™ Methamphetamine 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 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 Cassette Test | |
| is a qualitative immunoassay device intended to detect | ||
| methamphetamine in human urine at a cutoff level of 500 | ||
| 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 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 | ||
| appearance of two lines - both C line and T line indicates | ||
| Discussion and | ||
| Conclusion | a negative result, and the methamphetamine level is | |
| below 500 ng/ml. |
• 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
Methamphetamine/Antibody/Methamphetamine
complexes.
• The correlation of results from the Instant-View™
Methamphetamine Urine Cassette Test, is higher than
97.5 %. The results from all three POL sites agreed
98.3 %.
• The Accuracy Evaluation results from the Clinical
Laboratory conducted by persons with diverse
educational background and working experiences 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 Cassette 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. | |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human figures or profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 4 2000
Ms. Rhoda Filipina OA Manager Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road Suite M San Diego, California 92121
K994400 Re:
Trade Name: Instant-View Methamphetamine Urine Cassette Test Regulatory Class: II Product Code: DJC Dated: June 30, 2000 Received: July 6, 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 Cornetic 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 moponents, atte 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) premarker 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 Butman
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
K994400 510(k) Number (if known):
Instant-View Methamphetamine Urine Cassette Test Device Name:
Indications For Use:
Instant-View Methamphetamine Urine Cassette 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) recommends 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 preférred confirmatory method. matographyrinass Specif oprofessional judgment should be applied to any drug of abuse, Chilled Consideration and positive results are used. Land
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K994400
(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 er-ine-councer -8-9-96)