AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE

K012585 · Ameditech, Inc. · LAF · Nov 16, 2001 · Clinical Toxicology

Device Facts

• Record ID: K012585
• Device Name: AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE
• Applicant: Ameditech, Inc.
• Product Code: LAF · Clinical Toxicology
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Intended Use

The Ameditech ImmuTest™ Drug Screen METHAMPHETAMINE is an In Vitro screen test for the qualitative detection of Methamphetamine in human urine at cut-off concentration of 500 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 METHAMPHETAMINE is an in vitro diagnostic test for professional use. It utilizes human urine samples to qualitatively detect methamphetamine. The device provides a visual result based on a 500 ng/ml cut-off concentration. It is intended for clinical laboratory settings to assist in drug screening. The output is a qualitative visual indicator, which healthcare providers use to determine the presence of the drug, aiding in clinical decision-making regarding patient drug screening.

Technological Characteristics

In vitro diagnostic immunoassay; qualitative visual detection; cut-off concentration 500 ng/ml; human urine specimen.

Indications for Use

Indicated for professional in vitro qualitative detection of Methamphetamine in human urine at a 500 ng/ml cut-off concentration.

Regulatory Classification

Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 6 2001

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

Re: K012585

Trade/Device Name: Ameditech ImmuTest™ Drug Screen METHAMPHETAMINE Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine Test System Regulatory Class: II Product Code: LAF Dated: October 17, 2001 Received: October 19, 2001

Dear Dr. Wu:

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 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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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NOV 1 6 2001

Page i

510(k) Number (if known): 4012585

Device Name: Ameditech ImmuTest™ Drug Screen METHAMPHETAMINE

Indications For Use:

The Ameditech ImmuTest™ Drug Screen METHAMPHETAMINE is an In Vitro screen test for the qualitative detection of Methamphetamine in human urine at cut-off concentration of 500 ng/ml.

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

Tan Cooper

(Division Sign-Off) Division of Clinical Laboratory Levices 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)