ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000

K053034 · Acro Biotech, LLC · LDJ · Jun 6, 2006 · Clinical Toxicology

Device Facts

• Record ID: K053034
• Device Name: ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000
• Applicant: Acro Biotech, LLC
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Jun 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

Acro Rapid THC (Marijuana) Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of tetrahydrocannabinol in human urine at a cutoff of 50 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) analysis is preferred.

Device Story

Acro Rapid THC Urine Test is a lateral flow, rapid immunoassay for qualitative detection of tetrahydrocannabinol (THC) in human urine. Device consists of a test strip within a cassette containing a nitrocellulose membrane pre-coated with drug-protein conjugate and a wicking pad with antibody-colloidal gold conjugate. Principle of operation is competitive immunochemical reaction: in absence of THC, antibody-gold conjugate binds to immobilized drug-protein, forming a visible test line (negative result); in presence of THC, drug competes for binding sites, inhibiting test line formation (preliminary positive result). Device is for laboratory use; visually read by technician. Provides preliminary screening results; requires confirmation by GC/MS for clinical decision-making.

Clinical Evidence

Bench testing only. Performance evaluated via method comparison against GC/MS and predicate device using 130 urine specimens. Precision/reproducibility assessed at multiple sites using masked controls at 0, 25, 37.5, 62.5, 75, and 100 ng/mL. Analytical specificity tested against structurally related compounds and common interfering substances.

Technological Characteristics

Lateral flow, one-step immunoassay. Qualitative visual readout. 50 ng/mL cutoff. Manual test format.

Indications for Use

Indicated for the qualitative detection of tetrahydrocannabinol in human urine at a 50 ng/mL cutoff. Intended for laboratory use only to obtain preliminary results requiring confirmation by GC/MS.

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).

Submission Summary (Full Text)

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the bird.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 6 2006

Acro Biotech LLC. c/o Gregory Lee, Ph.D. 9500 760 Street Unit M Rancho Cucamonga, CA 91730

Re: k053034

Trade/Device Name: Acro Rapid (THC) Marijuana Urine Test Regulation Number: 21 CFR§862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ Dated: April 10, 2006 Received: April 10, 2006

Dear Dr. Lee;

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 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).

{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 Gutierrez

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}------------------------------------------------

## FDA INDICATIONS FOR USE FORM II.

## 510(K) NUMBER (IF KNOWN) k053034

Acro Rapid THC (Marijuana) Urine Test Device Name:

## Indications for Use

Acro Rapid THC (Marijuana) Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Tetrahydrocannabinol (Marijuana) in human urine at a cutoff of 50 ng/mL The test is used to obtain a visual qualitative result and is intended for laboratory use only.

This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.

> Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Carol C. Benson

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K053034