AMEDITECH IMMUTEST DRUG SCREEN OPIATES

K012483 · Ameditech, Inc. · DJG · Nov 30, 2001 · Clinical Toxicology

Device Facts

• Record ID: K012483
• Device Name: AMEDITECH IMMUTEST DRUG SCREEN OPIATES
• Applicant: Ameditech, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Nov 30, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

The Ameditech ImmuTest™ Drug Screen OPIATES is an In Vitro screen test for the qualitative detection of opiate metabolites in human urine at cut-off concentration of 2000 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 OPIATES is an in vitro diagnostic test for qualitative detection of opiate metabolites in human urine. Device utilizes lateral flow immunoassay technology; sample applied to test device; visual qualitative result obtained based on presence or absence of colored lines at specific cut-off concentration of 2000 ng/ml. Intended for professional use in clinical settings. Provides rapid screening results to healthcare providers to assist in identifying potential opiate presence; results are qualitative and intended for preliminary screening; positive results typically require confirmation by alternative chemical methods (e.g., GC/MS).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lateral flow immunoassay for qualitative detection of opiate metabolites. Cut-off concentration: 2000 ng/ml. Sample matrix: human urine. Visual readout format.

Indications for Use

Indicated for the qualitative detection of opiate metabolites in human urine for professional use. Intended for use as an in vitro screening test at a cut-off concentration of 2000 ng/ml.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by three abstract, flowing lines that resemble human figures or waves. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

k012483 Re:

Trade/Device Name: Ameditech ImmuTest™ Drug Screen Opiates Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG 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 device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

Page 2 -

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 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 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

{2}------------------------------------------------

Page of

510(k) Number (if known):

Ameditech ImmuTest™ Drug Screen OPIATES Device Name:

Indications For Use:

The Ameditech ImmuTest™ Drug Screen OPIATES is an In Vitro screen test I he Annualitative detection of opiate metabolites in human urine at cut-off concentration of 2000 ng/ml.

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

Norman Danto

Division Sign-Off >ivision of Clinical Laboratory Devices 6012483 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)