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, consideration and positive results are used.

Device Description

This test is a one-step lateral flow chromatographic immunoassay.

AI/ML Overview

Here's an analysis of the provided information regarding the Instant-View™ Methamphetamine Urine Cassette Test, structured to address your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to a legally marketed predicate device (QuikStrip One Step Methamphetamine Test, K970395). The summary does not explicitly state pre-defined acceptance criteria values in a formal table; instead, it reports performance findings that are deemed sufficient to establish substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
High correlation with analytical results (likely referring to the predicate or a confirmatory method like GC/MS)	"The correlation of results from the Instant-View™ Methamphetamine Urine Cassette Test, is higher than 97.5 %."
High agreement across different testing sites (e.g., POLs)	"The results from all three POL sites agreed 98.3 %."
High accuracy in clinical laboratory settings (with diverse users)	"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."
Substantial equivalence to the predicate device for intended use and technological characteristics	Concluded as "substantially equivalent to the existing legally marketed device."

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 "correlation of results," "POL sites agreement," or "Accuracy Evaluation" studies.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It mentions "all three POL sites" (Physician Office Laboratories) and a "Clinical Laboratory," suggesting clinical data, but further details are not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: The document mentions the "Clinical Laboratory conducted by persons with diverse educational background and working experiences." This is a general statement and does not specify the qualifications of experts establishing ground truth or interpreting results, beyond indicating that varying levels of expertise were involved in using the device. For establishing ground truth, it implies the expected results were determined by a reliable method, but the personnel involved are not detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set results. The agreement percentages suggest comparisons to an expected result or between different readers/sites, but the method of resolving discrepancies is not detailed.

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

This device is an immunoassay test kit, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted. There is no AI component.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Again, this is a diagnostic test kit, not an algorithm. The "standalone" performance would typically refer to the device's ability to produce a result without human interpretation of complex images or data. In this context, the device itself provides a visual result (line appearance), which is then interpreted by a human. The "correlation of results," "POL sites agreement," and "Accuracy Evaluation" could be considered indicators of its "standalone" performance in terms of generating the correct biochemical signal.

7. The Type of Ground Truth Used

The document implies the use of an "expected result" for the "Accuracy Evaluation" and a reference method for "correlation of results" and "POL sites agreement." Given the nature of a drug test, the ground truth would likely be established by a highly sensitive and specific confirmatory method, such as Gas Chromatography/Mass Spectrophotometry (GC/MS), which is explicitly mentioned as the "preferred confirmatory method" in the Indications for Use section (though not explicitly stated as the ground truth for the studies themselves, it's highly implied for drug testing validation).

8. The Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's a lateral flow immunoassay. Its development would involve chemical optimization and validation, not algorithmic training on a dataset. Therefore, the concept of a training set sample size is not applicable.

9. How the Ground Truth for the Training Set Was Established

As explained above, there is no "training set" for this type of device. The ground truth for the validation or performance evaluation of the immunoassay, if it involved external comparison, would likely be established via a gold standard laboratory method like GC/MS.

Summary

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K994400

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 MSan Diego, CA 92121Telephone: (858) 350-9798Fax: (858) 350-9709Email: asdi@worldnet.att.net
Device Name	Trade Name:	Instant-View™ Methamphetamine UrineCassette Test
	Common Name:	Methamphetamine Test
	Classification Name:	21 CFR 862.3610, Class II
Predicate Device	The Instant-View™ Methamphetamine Urine Cassette Testis substantially equivalent to other legally marketed devicesfor the similar intended use. The device used forcomparison study is QuikStrip One Step MethamphetamineTest, manufactured by Syntron Bioresearch, Inc. with510(K) #: K970395, Date of Approval: 06/26/97.
Device Description	This test is a one-step lateral flow chromatographicimmunoassay.
Intended Use	The Instant-View™ Methamphetamine Urine Cassette Testis a qualitative immunoassay device intended to detectmethamphetamine in human urine at a cutoff level of 500ng/ml. It is intended for health care professional use only.
Summary of theSimilarities to thePredicate Device	• Intended Use:	Both devices are intended to detect methamphetamine inhuman urine at a cutoff level of 500 ng/ml.
		• Interpretation of results:The appearance of only one line - C line, indicates aPositive result, and that the methamphetamine level is ata cutoff level of 500 ng/ml or higher. And, theappearance of two lines - both C line and T line indicates
Discussion andConclusion	a negative result, and the methamphetamine level isbelow 500 ng/ml.• Technological Characteristics:Both devices are one step, qualitative, competitivebinding immunoassay test, utilizing the basicimmunochemical sandwich assay principle ofrecognition and formation of the specificMethamphetamine/Antibody/Methamphetaminecomplexes.• The correlation of results from the Instant-View™Methamphetamine Urine Cassette Test, is higher than97.5 %. The results from all three POL sites agreed98.3 %.• The Accuracy Evaluation results from the ClinicalLaboratory conducted by persons with diverseeducational background and working experiences agreed95.2% with the expected results.• Based on the results of the Performance Characteristicsand Comparison Studies, it may be concluded that theInstant-View™ Methamphetamine Urine Cassette Testis suitable for use by health care professionals withdiverse educational backgrounds and work experiences,and it is substantially equivalent to the existing legallymarketed 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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K994400 510(k) Number (if known):

Instant-View Methamphetamine Urine Cassette Test Device Name:

Indications For Use:

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)

Regulation Number and Section

§ 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).