ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC

K060810 · Ind Diagnostic, Inc. · DKZ · Aug 7, 2006 · Clinical Toxicology

Device Facts

• Record ID: K060810
• Device Name: ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC
• Applicant: Ind Diagnostic, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Aug 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The One Step Drugs of Abuse Test is a prescription lateral flow competitive immunoassay panel or single test intended for professional central laboratory use by trained users. It provides qualitative visual screening results for Marijuana, Cocaine, Morphine, Amphetamine and Methamphetamine at cutoff concentrations of 50 ng/mL Marijuana, 300 ng/mL Morphine, 1000 ng/mL Morphine, 1000 ng/mL Amphetamine and 1000 ng/mL Methamphetamine in urine in combinations (Multi-Panel) or separately (Single). It is not intended for over the counter sales to the lay person. For in vitro diagnostic use only. As with all qualitative tests, this assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method

Device Story

Lateral flow competitive immunoassay; detects drugs of abuse in urine. Input: urine sample (dip strip or cassette well). Principle: drug conjugate competes with drug in urine for limited antibody binding sites; antibody-colloid gold conjugate moves via capillary action. Output: visual pink line on test band (negative) or absence of line (positive). Used in professional central laboratories by trained personnel. Provides preliminary screening results; requires confirmatory testing (GC/MS) for clinical decision-making. Benefits: rapid, qualitative identification of drug presence to guide further diagnostic or clinical action.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lateral flow competitive immunoassay; visual readout; urine matrix; cutoff concentrations: 50 ng/mL (Marijuana), 300/1000 ng/mL (Morphine), 1000 ng/mL (Amphetamine/Methamphetamine).

Indications for Use

Indicated for professional laboratory use for qualitative screening of Marijuana, Cocaine, Morphine, Amphetamine, and Methamphetamine in human urine. Not for OTC or point-of-care use.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine 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)

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the body, wings, and tail feathers. The text is in a simple, sans-serif font.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Jason Peng Regulatory Affairs Manager IND Diagnostic, Inc. 1629 Fosters Way Delta, B.C V3M 6S7 Canada

AUG - 7 2006

Re: k060810

Trade/Device Name: One Step DOA-2, DOA-4 Multi-Panel Test One Step Amphetamine Test- Cassette and Strip Formats One Step Methamphetamine Test- Cassette and Strip Formats One Step Cocaine Test- Cassette and Strip Formats One Step Morphine Test- Cassette and Strip Formats One Step Marijuana Test- Cassette and Strip Formats Regulation Number: 21 CFR §862.3100 Amphetamine Test System Regulation Name: Regulatory Class: Class II

Product Code: DKZ, LDJ, DIO, DIO, DPK Dated: June 29, 2006

Received: July 3, 2006

Dear Mr. Peng:

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 be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso be acribed 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 vith 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).

{1}------------------------------------------------

## 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/industry/support/index.html.

Sincerely yours,

Alberto Garcia

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known):

KOGO810

Device Name:

One Step DOA-2, DOA-3, DOA-4, DOA-5 Multi Panel Test One Step Amphetamine Test - Cassette and Strip Formats One Step Methamphetamine Test - Cassette and Strip Formats One Step Cocaine Test - Cassette and Strip Formats One Step Morphine Test - Cassette and Strip Formats One Step Marijuana Test - Cassette and Strip Formats

## Indications For Use:

The One Step Drugs of Abuse Test is a prescription lateral flow competitive immunoassay panel or single test intended for professional central laboratory use by trained users. It provides qualitative visual screening results for Marijuana, Cocaine, Morphine, Amphetamine and Methamphetamine at cutoff concentrations of 50 ng/mL Marijuana, 300 ng/mL Morphine, 1000 ng/mL Morphine, 1000 ng/mL Amphetamine and 1000 ng/mL Methamphetamine in urine in combinations (Multi-Panel) or separately (Single). It is not intended for over the counter sales to the lay person.

For in vitro diagnostic use only.

As with all qualitative tests, this assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method

Prescription Use X (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) Office of In Vitro Diagnostic Device Evaluation and Safety

si(k) K060810

Page 6