INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST

K994399 · Alfa Scientific Designs, Inc. · DKZ · Aug 4, 2000 · Clinical Toxicology

Device Facts

• Record ID: K994399
• Device Name: INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Aug 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The 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.

Device Story

The Instant-View Amphetamine Urine Dip Strip Test is a lateral flow chromatographic immunoassay used by healthcare professionals in clinical settings. The device detects amphetamine in human urine samples via a competitive binding principle; specific Amphetamine/Antibody/Amphetamine complexes form on the test strip. A single control line indicates a positive result (amphetamine level ≥ 1000 ng/ml), while two lines (control and test) indicate a negative result (amphetamine level < 1000 ng/ml). The device provides preliminary results that require confirmation by a more specific method like GC/MS. Clinical decision-making relies on professional judgment applied to these preliminary findings.

Clinical Evidence

Performance evaluated via comparison studies against the predicate device. Results showed >94.2% correlation. Testing at three Physician's Office Laboratory (POL) sites demonstrated 95.0% agreement. Accuracy evaluation conducted by users with diverse educational and work backgrounds across a clinical laboratory and three physician offices showed 92.2% agreement with expected results.

Technological Characteristics

One-step, qualitative, competitive binding lateral flow chromatographic immunoassay. Utilizes immunochemical sandwich assay principle for Amphetamine/Antibody/Amphetamine complex formation. Form factor is a dip strip. No electronic components or software algorithms.

Indications for Use

Indicated for the qualitative detection of amphetamine in human urine at a 1000 ng/ml cutoff level. Intended for health care professional use only. Provides preliminary analytical results; requires confirmation via alternate chemical method (e.g., GC/MS).

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• QuikStrip OneStep Amphetamine Test (K971218)

Submission Summary (Full Text)

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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 M<br>San Diego, CA 92121<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 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 is<br>substantially equivalent to other legally marketed devices<br>for the similar intended use. The device used for<br>comparison study is QuikStrip OneStep Amphetamine Test,<br>manufactured by Syntron Bioresearch, Inc. with 510(K) #:<br>K971218, Date of Approval: 05/30/97. |
| Device Description | This test is a one-step lateral flow chromatographic<br>immunoassay. |
| Intended Use | The Instant-View™ Amphetamine Urine Dip Strip Test is a<br>qualitative immunoassay device intended to be used for<br>detecting Amphetamine in human urine at a cutoff level of<br>1000 ng/ml. It is for health care professional use only. |
| Summary of the<br>Similarities to the<br>Predicate Device | • Intended Use:<br>Both devices are intended to detect amphetamine in<br>human urine at a cutoff level of 1000 ng/ml.<br>• Interpretation of results:<br>The appearance of only one line - C line indicates a<br>positive result, and that the amphetamine level at a cutoff<br>level of 1000 ng/ml or higher. And, the appearance of |
| | two lines – both C line and T line indicates a negative<br>result, and that the amphetamine level is below 1000<br>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 specific Amphetamine/<br>Antibody/Amphetamine complexes. |
| Discussion and<br>Conclusion | 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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)