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.

Device Description

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Instant-View™ Methamphetamine Urine Dip Strip Test, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Threshold)	Reported Device Performance
Correlation with Predicate Device	Not explicitly stated as a numerical 'acceptance criteria', but implied to be high for regulatory approval.	> 97.9% correlation with the legally marketed predicate device (QuikStrip One Step Methamphetamine Test).
Agreement across POL Sites	Not explicitly stated as a numerical 'acceptance criteria', but implied to be high for regulatory approval.	99.2% agreement among the three Physician's Office Laboratory (POL) sites.
Accuracy (Clinical Laboratory & POL)	Not explicitly stated as a numerical 'acceptance criteria', but implied to be high for regulatory approval.	95.2% agreement with expected results from the Clinical Laboratory and three Physician's Offices.

Note on "Acceptance Criteria": The document doesn't explicitly list numerical acceptance criteria in the format "The device must achieve X%." Instead, it presents the reported performance directly, implying that these results were deemed acceptable for regulatory clearance.

2. Sample Size and Data Provenance

Test Set Sample Size: Not explicitly stated in the provided text. The document mentions "results from the Instant-View™ Methamphetamine Urine Dip Strip Test" and "results from the three POL sites" and "Accuracy evaluation results from Clinical Laboratory and the three Physician's Offices," but the number of actual samples tested is not given.
Data Provenance: The study was conducted for regulatory purposes in the USA implicitly, as it's a 510(k) submission to the FDA. It appears to be a prospective study as it involves evaluation of a new device against a predicate and "expected results."

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not explicitly stated. The document mentions "persons with diverse educational backgrounds and working experience" for the Accuracy evaluation, but it doesn't specify how many individuals contributed to establishing the ground truth reference values for the samples used in the study.
Qualifications of Experts: Described generally as "persons with diverse educational backgrounds and working experience." No specific qualifications like "radiologist with 10 years of experience" are provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It discusses "agreement" between sites and with "expected results," suggesting that a reference method or pre-determined values were used as a comparative standard rather than a consensus among multiple human readers of the test results themselves.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study typically assesses the improvement in human reader performance (e.g., diagnostic accuracy) when assisted by an AI device compared to without AI assistance. The Instant-View™ Methamphetamine Urine Dip Strip Test is a diagnostic test kit itself, not an AI-powered image analysis tool or decision support system for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, a standalone performance evaluation was conducted. The product itself, the "Instant-View™ Methamphetamine Urine Dip Strip Test," is a standalone diagnostic device. Its performance metrics (correlation, agreement, accuracy) were assessed directly, without an explicit "human-in-the-loop" component for interpreting the test's visual results in the context of the study's performance evaluation (though the test is intended for use by healthcare professionals who will read the visual result). The "accuracy" and "correlation" figures reported directly relate to the device's output.

7. Type of Ground Truth Used

The ground truth appears to be established by comparison with:

Legally marketed predicate device: "QuikStrip One Step Methamphetamine Test" for the correlation study.
"Expected results": For the Accuracy evaluation from the Clinical Laboratory and Physician's Offices, implying either a gold standard laboratory method (like GC/MS, which is mentioned as the preferred confirmatory method) or pre-determined reference values were used to define the true positive/negative status of samples.

8. Sample Size for the Training Set

The document does not mention a "training set" or its sample size. This is a point-of-care immunoassay device, not a machine learning or AI-driven system that typically requires a training set. The development process would likely involve various stages of assay optimization and internal validation rather than a distinct "training set" in the machine learning sense.

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

As no training set is discussed or implied for an AI/ML context, this question is not applicable based on the provided text. The "training" of such a device is through biochemical and engineering design, not data-driven machine learning.

Summary

{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 MSan Diego, CA 92121Telephone: (858) 350-9798Fax: (858) 350-9709Email: asdi@worldnet.att.net
Device Name	Trade Name: Instant-View™ Methamphetamine Urine Dip Strip TestCommon Name: Methamphetamine TestClassification 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 theSimilarities to thePredicate 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:

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.

(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)

Over-The-Counter-Use (Optional Format 1-2-96)

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).