AMEDITECH IMMUTEST DRUG SCREEN PCP

K012582 · Ameditech, Inc. · LCM · Nov 30, 2001 · TX

Device Facts

• Record ID: K012582
• Device Name: AMEDITECH IMMUTEST DRUG SCREEN PCP
• Applicant: Ameditech, Inc.
• Product Code: LCM · TX
• Decision Date: Nov 30, 2001
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

The Ameditech ImmuTest™ Drug Screen PCP is an In Vitro screen test for the qualitative detection of Phencyclidine in human urine at cut-off concentration of 25 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 PCP is an in vitro diagnostic test for qualitative detection of Phencyclidine in human urine. Device utilizes lateral flow immunoassay technology to provide visual results at a 25 ng/ml cut-off concentration. Intended for professional use in clinical or laboratory settings. Healthcare providers interpret visual bands on the test device to determine presence of PCP. Results assist in preliminary screening for drug use; positive results typically require confirmation by alternative chemical methods.

Clinical Evidence

No clinical data provided; device relies on bench testing for analytical performance validation of the qualitative immunoassay.

Technological Characteristics

Lateral flow immunoassay for qualitative detection of Phencyclidine. Cut-off concentration: 25 ng/ml. Sample matrix: human urine. Visual readout format. Professional use only.

Indications for Use

Indicated for the qualitative detection of Phencyclidine (PCP) in human urine at a cut-off concentration of 25 ng/ml. Intended for professional use.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

NOV 3 0 2001

k012582 Re: Trade/Device Name: Ameditech ImmuTest™ Drug Screen PCP Regulatory Number: Unclassified Product Code: LCM 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 wo have a rowe 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 for ass stated in the 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 I ou may, atere, and servisions 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 or any I vithe 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 Orth 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 notification. The I Dri intellig of succion 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 CFFR Part 801 and 1 II you desire specific acrice for your actic devices), please contact the Office of Compliance at additionally 809.10 for m viro diagliestions on the promotion and advertising of your device, [phone]. Additionally, For quice 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 information on your responsionales and cranse at its toll-free number [phone] or Manufacturers International and Sollass "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

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510(k) Number (if known): Kola582

Ameditech ImmuTest™ Drug Screen PCP Device Name:

Indications For Use:

The Ameditech ImmuTest™ Drug Screen PCP is an In Vitro screen test for the qualitative detection of Phencyclidine in human urine at cut-off concentration of 25 ng/ml.

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

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number k012582

(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)