Instant-View™ Amphetamine Urine Dip Strip Test is a qualitative immunoassay device intended to be used for detecting Amphetamine in human urine at a cutoff level of 1000 ng/ml. It is for health care professional use only.

Instant-View Amphetamine Urine Dip Strip Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect amphetamine in human urine at a cutoff level of 1000 ng/ml. It is intended for health care professional use only.

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 detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided 510(K) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Correlation with Predicate Device	High correlation (exact percentage not explicitly stated, but "substantially equivalent" implies high agreement)	Higher than 94.2%
Agreement across POL Sites (Clinical Utility)	High agreement across diverse users (exact percentage not explicitly stated, but ensures usability by healthcare professionals)	95.0%
Accuracy (Agreement with Expected Results)	High accuracy (exact percentage not explicitly stated, but ensures reliable detection)	92.2%
Intended Use	Detect Amphetamine in human urine at a cutoff level of 1000 ng/ml. For health care professional use only.	Device successfully performs this function.

Note on Acceptance Criteria: The provided document does not explicitly state numerical acceptance criteria in a dedicated section. Instead, these are inferred from the reported performance results and the conclusion that the device is "substantially equivalent." For example, the 94.2% correlation with the predicate and 92.2% accuracy are presented as evidence of meeting acceptable performance, rather than being compared against a pre-defined threshold. The 95.0% agreement across POL sites further supports its practical utility.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set. It mentions "results from all three POL sites" and "Accuracy Evaluation results from the Clinical Laboratory and the three Physician's Offices." This indicates that the testing involved multiple clinical environments and an internal clinical laboratory, suggesting a multi-site evaluation.

Data Provenance:

Country of Origin: Not explicitly stated, but given Alfa Scientific Designs, Inc. is in San Diego, CA, and the FDA approval, it is highly likely the data was collected in the United States.
Retrospective or Prospective: Not explicitly stated. However, the nature of a 510(k) submission for a new device typically involves prospective testing to demonstrate performance under controlled conditions. The "Accuracy Evaluation" and "Comparison Studies" would involve newly generated data from testing the device.

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

The document does not explicitly state the number of experts or their specific qualifications for establishing ground truth for the test set.

However, it does mention that the "Accuracy Evaluation results from the Clinical Laboratory and the three Physician's Offices conducted by persons with diverse educational backgrounds and working experience agreed 92.2 % with the results expected." This implies that the 'ground truth' or 'expected results' were either:

Established by standard laboratory methods at a clinical laboratory.
Determined by the "legally marketed test device" (the predicate device) in the comparison study.

Given the device type (amphetamine urine dip strip), the initial assessment would likely be compared against a more robust laboratory method or the established performance of the predicate. The "persons with diverse educational backgrounds and working experience" refers to the users testing the device, not necessarily the experts establishing ground truth for each sample.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1). The "ground truth" for the comparison study appears to be the results obtained from the predicate device (QuikStrip OneStep Amphetamine Test) and, for the accuracy evaluation, "expected results" likely derived from a validated laboratory method (e.g., GC/MS, though not explicitly stated as the ground truth method for the entire comparison).

The agreement percentages (94.2% with predicate, 92.2% accuracy) suggest a direct comparison of the test device's result against the established reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This device is a rapid diagnostic test (dip strip) that provides a qualitative result. It is not an AI-powered diagnostic imaging or interpretation tool that would typically involve human readers and AI assistance. The study focuses on the device's performance against a predicate and expected lab results.

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

This question is not applicable in the typical sense of standalone AI algorithm performance. The device itself is a "standalone" chemical immunoassay test that provides a result, which is then interpreted by a healthcare professional. There is no "human-in-the-loop" in terms of an AI algorithm assisting interpretation; the human reads the dip strip directly. The performance metrics presented (correlation, agreement, accuracy) are indicative of the device's standalone analytical performance.

7. The Type of Ground Truth Used

The ground truth appears to be a combination of:

Predicate Device Results: For the "Comparison Studies," the results of the legally marketed QuikStrip OneStep Amphetamine Test (K971218) served as a comparative ground truth.
Expected Results (likely from reference laboratory methodology): For the "Accuracy Evaluation results from the Clinical Laboratory" these "expected results" would generally come from a highly accurate and validated method, such as Gas Chromatography/Mass Spectrophotometry (GC/MS), which is explicitly mentioned as the "preferred confirmatory method" in the Indications for Use. While not explicitly stated that GC/MS was the method for defining ground truth in the study, it's the gold standard for confirmation.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This is expected as the Instant-View™ Amphetamine Urine Dip Strip Test is a chemical immunoassay, not a machine learning or AI-based device that typically requires a training set. Its development would involve chemical and biological engineering, not algorithmic training.

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

This question is not applicable, as there is no "training set" for this type of device.

Summary

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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™ Amphetamine Urine Dip Strip Test
	Common Name: Amphetamine Test
	Classification Name: 21 CFR 862.3100, Class II
Predicate Device	The Instant-View™ Amphetamine Urine Dip Strip Test issubstantially equivalent to other legally marketed devicesfor the similar intended use. The device used forcomparison study is QuikStrip OneStep Amphetamine Test,manufactured by Syntron Bioresearch, Inc. with 510(K) #:K971218, Date of Approval: 05/30/97.
Device Description	This test is a one-step lateral flow chromatographicimmunoassay.
Intended Use	The Instant-View™ Amphetamine Urine Dip Strip Test is aqualitative immunoassay device intended to be used fordetecting Amphetamine in human urine at a cutoff level of1000 ng/ml. It is for health care professional use only.
Summary of theSimilarities to thePredicate Device	• Intended Use:Both devices are intended to detect amphetamine inhuman urine at a cutoff level of 1000 ng/ml.• Interpretation of results:The appearance of only one line - C line indicates apositive result, and that the amphetamine level at a cutofflevel of 1000 ng/ml or higher. And, the appearance of
	two lines – both C line and T line indicates a negativeresult, and that the amphetamine level is below 1000ng/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 specific Amphetamine/Antibody/Amphetamine complexes.
Discussion andConclusion	The correlation of results from the Instant-View™ Amphetamine Urine Dip Strip Test, and the legally marketed test device compared, is higher than 94.2 %. The results from all three POL sites agreed 95.0 %. The Accuracy Evaluation results from the Clinical Laboratory and the three Physician's Offices conducted by persons with diverse educational backgrounds and working experience agreed 92.2 % with the results expected. Based on the results of the Performance Characteristics and Comparison Studies, it may be concluded that the Instant-View™ Amphetamine 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.

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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 image of three overlapping lines that resemble a person embracing another person, which is a common symbol used by the department to represent its mission of providing essential human services.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

4 2000 AUG

Ms. Rhoda Filipina OA Manager Alfa Scientific Designs, Inc. 11494 Sorrento Valley Road Suite M San Diego, California 92121

K994399 Re:

Trade Name: Instant-View Amphetamine Urine Dip Strip Test Regulatory Class: II Product Code: DKZ Dated: July 7, 2000 Received: July 10, 2000

Dear Ms. Filipina:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your becamer of (s) = is substantially equivalent (for the indications for use above and we nave determined and arketed predicate devices marketed in interstate commerce stated in the encrosure) to regary miles of the Medical Device Amendments, or to devices that prior to may 20, 1970, are endance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosments Act. The Act. The general controls provisions of the Act include requirements for annual provisions of the Free. " rivers, 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 (1 renance ripptoval), it they of bacyer . 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 mspections, uit Food and Drag innay result in regulatory action. In addition, FDA may publish comply with the Grill resorts 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 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/cdrh/dsma/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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K994399 510(k) Number (if known):

Device Name: Instant-View Amphetamine Urine Dip Strip Test
Device Name: _____________________________________________________________________________________________________

Indications For Use:

Instant-View Amphetamine Urine Dip Strip Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect amphetamine in compotitive binaning initiality of 1000 ng/ml. It is intended for health care professional use only.

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. mutographyrilates opposad professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.

Cooges

(Division Sign-Off)
Division of Clinical Laboratory Devices/
510(k) Number K994399
Devices

(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)

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).