QUICK SCREEN ONE STEP AMPHETAMINE TEST

K972577 · Phamatech · DIT · Aug 20, 1997 · Clinical Toxicology

Device Facts

• Record ID: K972577
• Device Name: QUICK SCREEN ONE STEP AMPHETAMINE TEST
• Applicant: Phamatech
• Product Code: DIT · Clinical Toxicology
• Decision Date: Aug 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of amphetamine, a central nervous system stimulating drug, in urine. Measurements that are 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.

Device Story

QuickScreen One Step Amphetamine Screening Test is an in-vitro diagnostic immunoassay for qualitative detection of amphetamine in urine. Device utilizes colloidal gold-labeled antibodies in a visual color sandwich immunoassay format. Sample is applied to test; presence of amphetamine results in formation of specific antibody/amphetamine complexes, visualized as color change. Used in clinical toxicology labs, physicians' offices, clinics, and law enforcement settings by professional technicians. Output is visual qualitative result (presence/absence of amphetamine). Results assist clinicians in diagnosis and treatment of amphetamine use or overdose and monitoring therapy. Benefits include rapid, point-of-care identification of amphetamine presence.

Clinical Evidence

Clinical evaluation included a clinical sample correlation study and a blind labeled amphetamine study. Testing performed by professional laboratory technicians. Results showed >97% correlation with Syva EMIT II and GC/MS methodology. Specific performance metrics reported: sensitivity 83/84 (98.8%), specificity 40/40 (100%), and accuracy 123/124 (99.2%).

Technological Characteristics

In-vitro diagnostic immunoassay; colloidal gold label; visual color sandwich immunoassay technology; immunochemical sandwich assay principle (antibody/AMP/antibody complex formation).

Indications for Use

Indicated for qualitative identification of amphetamine in urine for individuals suspected of amphetamine use or overdose. Intended for use in clinical toxicology labs, physicians' offices, drug-of-abuse clinics, and law enforcement agencies.

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

• ABI SureStep
• Syntron Bioresearch Amphetamine Test

Reference Devices

• Syva EMIT II

Submission Summary (Full Text)

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KA72577

AUG 20 1997

## 510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)

QuickScreenTM One Step Amphetamine Screening Test (9060) Identification:

Immunoassay for the Qualitative Detection of Amphetamine in Urine Description:

Name Of Manufacturer:

Phamatech 9265 Activity Road #112 / 113 San Diego, California 92126, USA

Intended Use: A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of amphetamine, a central nervous system stimulating drug, in urine. Measurements that are 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.

The QuickScreenTM One Step Amphetamine Test utilizes colloidal Technology: gold as the label like other commercially available immunoassays for drug of abuse (amphetamine) test kits, to qualitatively measures the presence of amphetamine by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the ABI SureStep (San Diego, CA 92121)and the Syntron Bioresearch Amphetamine Test (Vista, CA 92083). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / AMP / antibody / complexes.

The product performance characteristics of the QuickScreen TM Performance: One Step Amphetamine Test was evaluated in a clinical sample correlation study and a blind labeled amphetamine study. The results of these studies demonstrate the Phamatech QuickScreenTM One Step Amphetamine Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of amphetamine in urine. Correlation studies, using clinical specimens, produced a >97% correlation when compared to the Syva EMIT II (San Jose, CA 95161) and the GC/MS methodology. Two clinical laboratory studies were performed, the Phamatech QuickScreen™ exhibited excellent sensitivity (83/84), specificity (40/40), and accuracy (123/124) in the hands of professional laboratory technicians.

Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech QuickScreen™ One Step AmphetamineTest is substantially equivalent to a variety of qualitative amphetamine tests currently in commercial distribution.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Carl A. Mongiovi Director of Operations Phamatech 9265 Activity Roads Suite 112-113 San Diego, California 92126 ... .....

AUG 20 1997

K972577 Re:

> Trade Name: QuickScreen™ One Step Amphetamine Screening Test Requlatory Class: II Product Code: DIT Dated: July 7, 1997 Received: July 10, 1997

Dear Mr. Mongiovi:

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 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 requlatory 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described i 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) Additionally, for questions on the promotion and 594-4588. advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

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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## INDICATIONS FOR USE

Applicant: Phamatech

510(k) Number (if known): _ K972577

Device Name: QuickScreen IM One Step AmphetamineTest

Indications for Use:

A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of amphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of amphetamine use and overdose.

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| Concurrence of CDRH Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K972577 |
| Division Sign-Off | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number: | |
| Prescription Use: | <div style="display:inline-block; vertical-align:middle;">✓</div> |
| OR Over the Counter | |
| Per 21 CFR 801.109 | |