ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE

K040629 · Accu-Stat Diagnostics, Inc. · LDJ · May 5, 2004 · Clinical Toxicology

Device Facts

• Record ID: K040629
• Device Name: ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE
• Applicant: Accu-Stat Diagnostics, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: May 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) is a single-unit screening test for the rapid detection of two to six of the above drugs in human urine. The designated cutoff concentrations for these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. The tests are intended for over-the-counter (OTC) consumer use as the first step in a two step process that includes confirmatory testing of preliminary positive results. Information, along with the materials for shipping a portion of the urine specimen to the laboratory is provided.

Device Story

Device is a rapid, one-step chromatographic immunoassay for qualitative detection of drugs of abuse in human urine. Input: urine specimen; process: competitive binding immunoassay where drug in sample competes with drug conjugate for antibody binding sites; output: visual colored line in test region (negative result) or absence of line (positive result). Used by lay consumers in home setting for preliminary screening. Healthcare providers or labs perform confirmatory testing on positive samples. Benefits patient by providing immediate, preliminary information regarding potential drug use.

Clinical Evidence

Consumer studies conducted to evaluate lay user performance. Results demonstrate excellent overall performance in the hands of lay users, supporting the conclusion that consumers can effectively use the test to obtain immediate, preliminary information regarding the presence of target drugs.

Technological Characteristics

One-step rapid chromatographic immunoassay; competitive binding principle. Device utilizes antibody-coated particles and immobilized drug conjugates. Form factor: test card/well for urine sample application. No external energy source required; visual readout via colored lines. No software or electronic components.

Indications for Use

Indicated for OTC consumer use for rapid, qualitative screening of human urine for 2-6 drugs (THC, COC, AMP, mAMP, OPI, PCP) at specified cutoff concentrations. Intended as a first-step screening tool requiring confirmatory laboratory testing for preliminary positive results.

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).

Predicate Devices

• First Check® Home Drug Test for Marijuana, Cocaine, Mcthamphetamine, & Opiates (K993852)
• Phamatech At Home™ Drug Test for Amphetamine, Methamphetamine (Ecstasy), Marijuana, Cocaine, and Opiates (K003858)

Reference Devices

• ACON Laboratories One Step Multi-Drug Multi-Line Screen Test Device (K020313)
• Advantage Diagnostics Home Drug Tests

Submission Summary (Full Text)

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K040629

# MAY - 5 2004

#### Section D

### 510(k) Summary J As required by 21 CFR 807.92 ]

## I. Submitter: A. Name: Accu-Stat Diagnostics, Inc. B. Address: 11 Orchard Road, Suite # 108, Lake Forest, CA 92630 C. Phone and Fax Numbers: Phone [phone] Fax D. Contact Person: James G. Barrons Date of Preparation of this Summary: 9 March 2004 II. Trade Name: Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine III. (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) Common Name: At home rapid screening test for Marijuana (THC), Cocaine IV. (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) in urine. Classification Name: Immunoassay for the qualitative detection of drugs of V. abuse in urine. VI. The Marketed Products to Which Equivalence is claimed: The Accu-Stat™Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) is substantially equivalent to the First Check® Home Drug Test for Marijuana, Cocaine, Mcthamphetamine, & Opiates (K993852), and the Phamatech At Home™ Drug Test for Amphetamine, Methamphetamine (Ecstasy), Marijuana, Cocaine, and Opiates (K003858), and other commercially available drug screening tests that qualitatively measure the presence of target drugs or metabolites by visual color one-step immunoassay technology.

- VII. Statement of Intended Use Compared to Other Products: The intended use of the Accu-Stat™ Home Drug Tests for Marijuana. Cocaine, Amphetamine, Opiates, Methamphetamine, and Phencyclidine is substantially equivalent to the above listed products and is a single unit screening test for the detection of from two to six of the listed drugs in human urine. The designated cut-off concentrations for these drugs are as follows: Marijuana at 50 ng/ml, Cocaine

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at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. These tests are intended for over-the-counter (OTC) consumer use as the first step in a twostep process that includes confirmatory testing of preliminary positive results. Information, along with the materials for shipping a portion of the urinc specimen to the laboratory is provided.

- Discussion of Technological Characteristics: The Accu-Stat™ Home Drug VIII. Test for Marijuana, Cocaine, Amphctamine, Methamphetamine, Opiates, and Phencyclidine, like other commercially available drug screening tests, qualitatively measures the presence or absence of THC, COC, AMP, mAMP, OPI, PCP and their metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of competitive binding. Drugs, which may be present in the urine specimen, compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. Marijuana, if present in the urine specimen below 50 ng/ml, and the other drugs being tested for, if below the cut-off levels stated above, will not saturate the binding sites of the antibody coated particles in the test device. The antibody coated particles will then be captured by immobilized marijuana, cocaine, or other listed drug conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the marijuana level is above the 50 ng/ml because it will saturate all the binding sites of antimarijuana antibodies. The same holds true for cocaine and the other drugs if the level is above the cut-off. It will saturate all the binding sites of anticocaine (or other drug) antibodies and therefore the colored line will not form in the test region.
A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of a drug competition. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

Examples of predicate devices include the First Check® Home Drug Tests and the Phamatech At Home Drug Tests using a single or a multi-drug display. The consumer studies using the Accu-Stat™ Home Drug Test for Marijuana, Cocaine, Amphetamine, Methamphetamine Opiates, and Phencyclidine demonstrates that the test exhibits excellent overall performance in the hands of lay users. The data supports the conclusion that the consumer can use the Accu-Stat™ Home Drug Tests to obtain immediate, preliminary information regarding the possible use of THC, COC, AMP, mAMP, OPI, and PCP.

- IX. Safety and Effectiveness: Because the Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine,

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(mAMP), Opiates (OPI), and Phencyclidine are identical to the ACON Laboratories One Step Multi-Drug Multi-Line Screen Test Device that is legally marketed under K020313 for professional use, and because no special skills, training, education, or licensing is required to transfer a few drops of a urine sample into the test card well, there is no issue regarding the safety or effectiveness of the product to perform its intended function, i.e., to screen urine for the presence or absence of THC, COC, AMP, mAMP, OPI, or PCP and their metabolite(s). Because the labeling of the Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) is substantially equivalent to a variety of rapid screening tests currently in commercial distribution, including the First Check® Home Drug Test, the Advantage Diagnostics Home Drug Tests and the Phamatech At Home™ Drug Tests, and there have been no reports of consumer inability to follow instructions or interpret results over the many months these products have been purchased, it should be concluded that the product can be used effectively by the lay user.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY - 5 2004

Mr James G. Barrons President Accu- Stat Diagnostics, Inc. 11 Orchard Road Suite 108 Lake Forest, CA 92630

k040629 Re:

Trade/Device Name: Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ, DKZ, MVO, DIO, LAF, DJG, and LCM Dated: March 9, 2004 Received: March 10, 2004

Dear Mr. Barrons:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please he advised that FDA's issuance of a substantial cquivalence 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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#### Page 2

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### Section A

### Indications for Use

## 510(k) Number (if known): K040629

Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine (COC), Device Name: Ambetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP),

#### Indications For Use:

The Accu-Stat™ Home Drug Test for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Opiates (OPI), and Phencyclidine (PCP) is a single-unit screening test for the rapid detection of two to six of the above drugs in human urine. The designated cutoff concentrations for these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml. The tests are intended for over-the-counter (OTC) consumer use as the first step in a two step process that includes confirmatory testing of preliminary positive results. Information, along with the materials for shipping a portion of the urine specimen to the laboratory is provided.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Tom Coogan
Division Sign-Off

Office of In Vitro Diagnostic Device Page 1 of Evaluation and Safety

510(k) Koyoloz