AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE

K012484 · Ameditech, Inc. · DKZ · Nov 30, 2001 · Clinical Toxicology

Device Facts

• Record ID: K012484
• Device Name: AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE
• Applicant: Ameditech, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Nov 30, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The Ameditech ImmuTest™ Drug Screen AMPHETAMINE is an In Vitro diagnostic device for the qualitative detection of Amphetamine in human urine at cut-off concentration of 1000 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use.

Device Story

Ameditech ImmuTest™ Drug Screen AMPHETAMINE is an in vitro diagnostic test kit for qualitative detection of amphetamine in human urine. Device utilizes immunoassay technology to provide visual qualitative results at a 1000 ng/ml cut-off concentration. Intended for professional use in clinical settings to assist in drug screening. Healthcare providers interpret visual results to determine presence of amphetamine, aiding in clinical decision-making regarding substance use assessment.

Clinical Evidence

No clinical data provided; device is an in vitro diagnostic test kit relying on analytical performance characteristics for substantial equivalence.

Technological Characteristics

In vitro diagnostic immunoassay test kit for qualitative detection of amphetamine in human urine. Operates via visual interpretation of test results at a 1000 ng/ml cut-off concentration. Professional use device.

Indications for Use

Indicated for professional use for the qualitative detection of Amphetamine in human urine at a cut-off concentration of 1000 ng/ml.

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).

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 3 0 2001

John Wu, Ph.D. Director of Quality Assurance Ameditech, Inc. 10340 Camino Santa Fe, Suite F San Diego, CA 92121

Re: k012484

K012484
Trade/Device Name: Ameditech ImmuTest™ Drug Screen Amphetamine Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ Dated: October 24, 2001 Received: October 31, 2001

Dear Dr. Wu:

We have reviewed your Section 510(k) premarket notification of intent to market the devices We have reviewed your Section 310(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosuly to regars and the Medical Device Ameral mendments, or to commerce prior to May 28, 1776, the enactions and the provisions of the Federal Food. Drug, devices that have been recassined in acceracited with a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval oppo and Cosmelle Act (Act) that do not require approvine the general controls provisions of the Act. The You may, therefore, market the devices, bogo cover coursements for annual registration, listing of general controls provisions of the rest labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in can If your device is classifica (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to suell additional controllations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs of events concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuation of a bacemination with other requirements of the Act
that FDA has made a determination that your device complies with other work that I DA has made a determination administered by other Federal agencies. You must or any Pederal Statutes and regulations adminitive. 8 3 7 100 limited to: registration and listing (21 comply with an the Act s requirements, mercuring practice requirements as set CFR Part 807), labeling (21 CFR Part 800), good market 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 81 GFR 1000 \$050 form in the quality systems (QD) regularia (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-10

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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 1 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 International and Consumer 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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Page

510(k) Number (if known):

Ameditech ImmuTest™ Drug Screen AMPHETAMINE Device Name:

Indications For Use:

The Ameditech ImmuTest™ Drug Screen AMPHETAMINE is an In Vitro I the American the qualitative detection of Amphetamine in human urine at cut-off concentration of 1000 ng/ml.

This test kit is used to obtain a visual, qualitative result and is intended for professional use.

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Division Sign-Off

Division of Clinical Laboratory Devices KAZZER 510(k) Number

(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)