AMEDITECH IMMUTEST DRUG SCREEN THC

K011813 · Ameditech, Inc. · LDJ · Oct 22, 2001 · Clinical Toxicology

Device Facts

• Record ID: K011813
• Device Name: AMEDITECH IMMUTEST DRUG SCREEN THC
• Applicant: Ameditech, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Oct 22, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The Ameditech ImmuTest™ Drug Screen THC is an In Vitro screen test for the detection of 11-nor-Δ'-THC-9-carboxylic acid (THC) in human urine at cut-off concentration of 50 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 THC is an in vitro diagnostic test for detecting 11-nor-Δ'-THC-9-carboxylic acid in human urine; utilizes lateral flow immunoassay technology; provides visual, qualitative results at a 50 ng/ml cut-off; intended for professional use in clinical settings; assists healthcare providers in identifying potential cannabinoid presence; facilitates preliminary screening decisions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing performance characteristics for an in vitro diagnostic screening test.

Technological Characteristics

Lateral flow immunoassay for qualitative detection of 11-nor-Δ'-THC-9-carboxylic acid in human urine; 50 ng/ml cut-off concentration; visual readout; professional use format.

Indications for Use

Indicated for professional use as an in vitro diagnostic screening test for the qualitative detection of 11-nor-Δ'-THC-9-carboxylic acid (THC) in human urine at a 50 ng/ml cut-off concentration.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid 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

OCT 22 2001

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

Re: k011813

Trade/Device Name: Ameditech ImmuTest™ Drug Screen THC Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ Dated: May 28, 2001 Received: June 11, 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.

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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 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/cdrb/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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Koll813 510(k) Number (if known):

Ameditech ImmuTest™ Drug Screen THC Device Name:

Indications For Use:

The Ameditech ImmuTest™ Drug Screen THC is an In Vitro screen test for I he Amediteen Immers of 11-nor-Δ'-THC-9-carboxylic acid (THC) in human urine at cut-off concentration of 50 ng/ml.

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

(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) |
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Kesia Alexander Jackson Cooper

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number K011813