DRUG STOP

K991465 · Texas Immunology, Inc. · MVO · Dec 10, 1999 · TX

Device Facts

• Record ID: K991465
• Device Name: DRUG STOP
• Applicant: Texas Immunology, Inc.
• Product Code: MVO · TX
• Decision Date: Dec 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Indications for Use

DrugStop is an at home drug screening test and if necessary a confirmation service. This product is a preliminary screen to detect and identify the presence of drugs within the body using a urine sample. The device is designed to detect the presence of COC (Cocain, Crack), THC (Marijuana, Pot, Cannabis), NOR (Opiates, Herion, Morphine), AMP (Amphetamine, Speed, Methamphetamine), PCPC (Angel Dust). DrugStop is the first step in a two step testing process. If a result is NEGATIVE, then, the person being tested probably does not have that drug in their body. HOWEVER, if the result is PRELIMINARY, the sample NUST be sent to our reference lab for confirmation at no additional cost to the customer. Home drug tests are not as accurate as lab tests and any PRELIMINARY results NUST BE CONFIRMED before any action is taken against the person being tested.

Device Story

DrugStop is an at-home, over-the-counter urine drug screening test. User collects urine sample; device performs preliminary qualitative detection of cocaine, THC, opiates, amphetamines, and PCP. If result is negative, no further action required. If result is preliminary positive, user must send sample to manufacturer's reference laboratory for definitive confirmation. Service includes confirmation at no additional cost. Device intended for consumer self-use to identify potential drug presence; results are preliminary and not diagnostic. Clinical decision-making requires laboratory confirmation before any action is taken against the tested individual.

Clinical Evidence

No clinical data provided in the document. The document focuses on regulatory clearance and the requirement for laboratory confirmation of preliminary results.

Technological Characteristics

At-home urine-based immunoassay screening test. Detects COC, THC, NOR, AMP, and PCPC. Requires secondary laboratory confirmation for preliminary positive results.

Indications for Use

Indicated for at-home preliminary screening of urine samples to detect presence of cocaine, THC, opiates, amphetamines, and PCP. Intended for use by consumers as a first-step screening tool; preliminary positive results require laboratory confirmation.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 0 1999

Mr. Charles W. Gill Director of Research & Development Texas Immunology, Inc. 12524 FM 3226 Tyler, Texas 75707

Re: K991465 Trade Name: DrugStop™ Regulatory Class: II Product Code: MVO Dated: September 29, 1999 Received: October 1, 1999

Dear Mr. Gill:

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 (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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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

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K991465 510(k) Number (if known):

Device Name: DRUG STOP

Indications For Use:

DrugStop is an at home drug screening test and if necessary a confirmation service. This product is a preliminary screen to detect and identify the presence of drugs within the body using a urine sample. The device is designed to detect the presence of COC (Cocain, Crack), THC (Marijuana, Pot, Cannabis), NOR (Opiates, Herion, Morphine), AMP (Amphetamine, Speed, Methamphetamine), PCPC (Angel Dust).

DrugStop is the first step in a two step testing process. If a result is NEGATIVE, then, the person being tested probably does not have that drug in their body. HOWEVER, if the result is PRELIMINARY, the sample NUST be sent to our reference lab for confirmation at no additional cost to the customer. Home drug tests are not as accurate as lab tests and any PRELIMINARY results NUST BE CONFIRMED before any action is taken against the person being tested.

Ron Coofa

(Division Sign-Off)
Division of Clinical Laboratory Devices

vision of Clinical Laboratory Devices

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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)