ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100

K053037 · Acro Biotech, LLC · DJG · Jun 15, 2006 · Clinical Toxicology

Device Facts

• Record ID: K053037
• Device Name: ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100
• Applicant: Acro Biotech, LLC
• Product Code: DJG · Clinical Toxicology
• Decision Date: Jun 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

Acro Rapid Opiate Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Opiate in human urine at a cutoff of 2000 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

Lateral flow, one-step immunoassay for qualitative detection of Opiate in human urine. Device utilizes competitive binding principle; urine sample migrates along test strip; presence of Opiate competes with drug conjugate for limited antibody binding sites. Visual qualitative result (colored line) indicates presence or absence of drug above 2000 ng/mL cutoff. Intended for laboratory use by professional personnel. Provides preliminary screening results; requires confirmation by GC/MS for clinical decision-making. Benefits include rapid, preliminary identification of Opiate presence to guide further diagnostic or clinical assessment.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Lateral flow, one-step immunoassay. Qualitative visual readout. Cutoff concentration: 2000 ng/mL. Analyte: Opiate. Sample matrix: human urine.

Indications for Use

Indicated for the qualitative detection of opiates in human urine at a 2000 ng/mL cutoff. Intended for professional laboratory use only. Provides preliminary results requiring confirmation by GC/MS.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

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

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "U.S. Department of Health and Human Services" are written in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

JUN 15 2006

Re: k053037 Trade/Device Name: Acro Raid Opiate Urine Test Regulation Number: 21 CFR\$862.3650 Regulation Name: . Opiate test system Regulatory Class: Class II Product Code: DJG Dated: May 10, 2006 Received: May 11, 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 udicetions for use stated in the enclosure) to legally marketed predicate devices marketed in intereste commerce prior to May 28, 1976, the enactment date of the Medical Device Amendonstits, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Orug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), 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, inst roce 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 Devistm

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),

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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 tollit the number [phone] or [phone] or at its Internet address. http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Albert Sutt

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

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Acro Biotech LLC. Acro Rapid Opiate Urine Test

#### FDA INDICATIONS FOR USE FORM II.

510(K) NUMBER (IF KNOWN) k053037

Device Name:

## Indications for Use

Acro Rapid Opiate Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of Opiate in human urine at a cutoff of 2000 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) |
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| Acro Biotech, LLC., 9500 7th Street #Unit M, Rancho Cucamonga CA 91730 |
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| Tel: [phone], Fax: [phone] |

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| Office of In Vitro Diagnostic Device Evaluation and Safety |
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