ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000

K053033 · Acro Biotech, LLC · DJC · Jun 6, 2006 · Clinical Toxicology

Device Facts

• Record ID: K053033
• Device Name: ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000
• Applicant: Acro Biotech, LLC
• Product Code: DJC · Clinical Toxicology
• Decision Date: Jun 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Intended Use

Acro Rapid Methamphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Methamphetamine in human urine at a cutoff of 500 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only. This assay provides only preliminary results. 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

Lateral flow, rapid immunoassay for qualitative detection of methamphetamine in human urine; utilizes competitive immunochemical reaction between immobilized drug-protein conjugate and drug metabolites in sample for limited antibody binding sites. Device consists of nitrocellulose membrane strip in cassette; wicking pad contains colored antibody-colloidal gold conjugate. Urine sample migrates via capillary action; absence of test line indicates preliminary positive result; presence of test line indicates negative result. Intended for laboratory use; visually read by technician. Provides preliminary screening results; requires confirmation via GC/MS for clinical decision-making.

Clinical Evidence

No clinical data. Performance established via bench testing, including precision/reproducibility studies across multiple sites using masked urine control samples and method comparison against GC/MS and predicate device.

Technological Characteristics

Lateral flow immunochromatographic assay; nitrocellulose membrane strip; antibody-colloidal gold conjugate; competitive binding principle. Visually read, single-use cassette. No electronic components or software.

Indications for Use

Indicated for the qualitative detection of Methamphetamine in human urine at a 500 ng/mL cutoff. Intended for laboratory use only to provide preliminary results requiring confirmation by GC/MS.

Regulatory Classification

Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles an eagle or bird with three wing-like shapes. The symbol is rendered in black and has a flowing, abstract design.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 6 2006

Acro Biotech LLC. c/o Gregory Lee, Ph.D. 9500 7th Street Unit M Rancho Cucamonga, CA 91730

Re: k053033

> Trade/Device Name: Acro Rapid Methamphetamine Urine Test Regulation Number: 21 CFR§862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: DJC 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 INDICTAIONS FOR USE FORM

# 510(K) NUMBER (IF KNOWN): k053033

Acro Rapid Methamphetamine Urine Test Device Name:

### Indications for Use

Acro Rapid Methamphetamine Urine Test is a lateral flow, rapid immunoassay for the qualitative detection of Methamphetamine in human urine at a cutoff of 500 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only.

This assay provides only preliminary results. 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.

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

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

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

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

Division Sign-Of

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K053033