INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST

K994395 · Alfa Scientific Designs, Inc. · DKZ · Aug 7, 2000 · Clinical Toxicology

Device Facts

• Record ID: K994395
• Device Name: INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Aug 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The Instant-View Amphetamine Urine Cassette 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 Story

Lateral flow chromatographic immunoassay for qualitative detection of amphetamine in human urine. Operates via competitive binding; specific Amphetamine/Antibody/Amphetamine complexes form on test strip. Input: human urine sample. Output: visual interpretation of test lines (C line only = positive; C and T lines = negative). Used in clinical settings or physician offices by healthcare professionals. Provides preliminary analytical results; requires GC/MS confirmation for clinical decision-making. Benefits patient by enabling rapid screening for amphetamine presence.

Clinical Evidence

Bench testing and clinical performance studies conducted. Accuracy evaluation performed at one clinical laboratory and three physician office laboratories (POLs) by personnel with diverse backgrounds. Results showed 95.0% agreement across POL sites and 92.2% overall accuracy compared to expected results. Correlation with predicate device was >94.6%.

Technological Characteristics

One-step lateral flow chromatographic immunoassay. Utilizes competitive binding and immunochemical sandwich assay principle. Form factor: cassette. No electronic components or software.

Indications for Use

Indicated for health care professionals to detect amphetamine in human urine at a 1000 ng/ml cutoff level. Provides preliminary results; requires confirmatory testing via 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.<br>Address: 11494 Sorrento Valley Road, Suite M<br>San Diego, CA 92121<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
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| Device Name | Trade Name: Instant-View™ Amphetamine Urine Cassette Test<br>Common Name: Amphetamine Test<br>Classification Name: 21 CFR 862.3100, Class II |
| Predicate Device | The Instant-View™ Amphetamine Urine Cassette 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 Cassette 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 is at a<br>cutoff level of 1000 ng/ml or higher. And, the |
| | appearance of two lines - both C line and T line indicates a negative result, and that the amphetamine level is below 1000 ng/ml.<br><br>Technological Characteristics:<br>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 and Conclusion | • The correlation of results from the Instant-ViewTM Amphetamine Urine Cassette Test, and the legally marketed test device compared, is higher than 94.6%. The results from all three POL sites agreed 95.0 %.<br><br>• The Accuracy Evaluation results from the Clinical Laboratory and the three Physician's Offices Laboratory conducted by persons with diverse educational backgrounds and working experience agreed 92.2 % with the results expected.<br><br>• Based on the results of the Performance Characteristics and Comparison Studies, it may be concluded that the Instant-ViewTM Amphetamine 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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## Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## AUG 7 2000

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

K994395 Re:

> Trade Name: Instant-View Amphetamine Urine Cassette Test -Regulatory Class: II Product Code: DKZ 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 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.

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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 packeted 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 Camplia.ce 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/cdrlv/dsma/dsmamain.html".

Sincerely yours,

Steven Gutman

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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K994395 510(k) Number (if known):

Device Name: Instant-View Amphetamine Urine Cassette Test

Indications For Use:

Instant-View Anıphetamine Urine Cassette 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.

(Division Sign-Off)
Division of Clinical Lat
510(k) Number: K994359

(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)