PEACE OF MIND HOME DRUG TEST

K013778 · Advantage Diagnostics Corp. · MVO · Feb 7, 2002 · TX

Device Facts

• Record ID: K013778
• Device Name: PEACE OF MIND HOME DRUG TEST
• Applicant: Advantage Diagnostics Corp.
• Product Code: MVO · TX
• Decision Date: Feb 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

The Peace of Mind Home Drug Test is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of THC, PCP, Opiates, Cocaine and Methamphetamine at the following cut off concentrations: THC 50ng/mL, PCP 25ng/mL, Opiates 2000ng/mL, Cocaine 300ng/mL, Methamphetamine 1000ng/mL. The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of any of the five drugs. Confirmation, using GC/MS, of a possible drug result is recommended as the second step.

Device Story

Immunochromatographic competitive assay; detects five drugs of abuse (THC, PCP, Opiates, Cocaine, Methamphetamine) in human urine. User collects urine sample; applies to test device; visual readout indicates presence or absence of drugs based on specified cut-off concentrations. Intended for home use; serves as initial screening step. Positive results require secondary confirmation via GC/MS. Provides consumers with preliminary drug presence information.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunochromatographic competitive assay; lateral flow format. Detects THC (50ng/mL), PCP (25ng/mL), Opiates (2000ng/mL), Cocaine (300ng/mL), and Methamphetamine (1000ng/mL).

Indications for Use

Indicated for qualitative screening of human urine for THC, PCP, Opiates, Cocaine, and Methamphetamine in consumers. Requires GC/MS confirmation for positive results.

Predicate Devices

• Phamatec QuickScreen At Home Test
• Drug Stop Test

Submission Summary (Full Text)

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FEB 0 7 2002

## 510(k) Summary

KU13778

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.

The assigned 510(k) number is:

1. Date of summary: November 8, 2001

- aLATEX Scientific Inc. 2. Submitted by: 6355 Westheimer Rd. Suite 105 Houston TX 77057
Peace of Mind Home Drug Test 3. Device Name:

4. Device Classification: Class II, Panel 91 Toxicology

5. Device description: The Peace of Mind Home Drug Test is an immunochromatographic based one step in vitro test for use at home.

6. Intended Use: The Peace of Mind Home Drug Test is designed for the qualitative determination of five drugs of abuse and their metabolites in human urine at the following cut off concentrations:

| THC | 50ng/mL |
|-----------------|-----------|
| PCP | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |

The test is the first part of a two-step process to provide consumers with information regarding the presence or absence of any of these drugs in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step.

7. Substantial Equivalence: The Peace of Mind Home Drug Test is substantially equivalent to several other professional and over the counter immunoassay Drugs of Abuse Tests, such as Phamatec QuickScreen™ At Home Test and the Drug Stop Test. These home drug tests are the first of a two-step process to detect the presence or absence of drugs of abuse in human urine and require consumers to confirm possible positive results with GC/MS.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract image of an eagle. The eagle is depicted with three stylized wing strokes and a curved body, symbolizing the department's mission related to health and human welfare. The logo is simple and monochromatic.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## FEB 0 7 2002

aLATEX Scientific Inc. c/o Ms. Janis Freestone Director, Regulatory Affairs Advantage Diagnostics Corporation, Ltd. 1201 Douglas Avenue Redwood City, CA 94063

k013778 Re:

Trade/Device Name: Peace of Mind Home Drug Test Regulation Number: 21 CFR 862.3870; 21 CFR 862.3250; 21CFR 862.3610; 21 CFR 862.3640 Regulation Name: Cannabinoid test system; Cocaine and cocaine metabolite test system; Methamphetamine test system; Morphine test system Regulatory Class: Class II; Class II; Class II; Class II; Class II Product Code: MVO; LDJ; DIO; DJC; DPK; LCM Dated: November 12, 2001 Received: November 13, 2001

Dear Ms. Freestone:

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 I hils letter will anow your of substantial equivalence of your device to a legally marketed nothication. The I Dri Intention 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 II you desire specific active actives), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, [phone]. Traditionally) and eat [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 mioritation on your respections.
Manufacturers International Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrfb/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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## K013778 510k Number:

Device Name: Peace of Mind Home Drug Test

Indications for Use:

The Peace of Mind Home Drug Test is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of THC, PCP, Opiates, Cocaine and Methamphetamine at the following cut off concentrations:

| THC | 50ng/mL |
|-----------------|-----------|
| РСР | 25ng/mL |
| Opiates | 2000ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1000ng/mL |

The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of any of the five drugs. Confirmation, using GC/MS, of a possible drug result is recommended as the second step.

Sian Cooper

(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K013778

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Image /page/3/Picture/11 description: The image shows the phrase "Over the counter use" with a symbol next to it. The symbol is a line with an X over it. This symbol is commonly used to indicate that something is not allowed or should not be done. The text and symbol together likely indicate that the product is not intended for over-the-counter use.