ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000

K060354 · Acro Biotech, LLC · JXM · Jul 28, 2006 · Clinical Toxicology

Device Facts

• Record ID: K060354
• Device Name: ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000
• Applicant: Acro Biotech, LLC
• Product Code: JXM · Clinical Toxicology
• Decision Date: Jul 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3170
• Device Class: Class 2

Intended Use

Acro Rapid Benzodiazepine Urine test is a lateral flow, rapid immunoassay for the qualitative detection of Oxazepam in human urine at a cutoff of 300 ng/mL. The test is used to obtain a visual qualitative result and is intended for laboratory use only. The assay provides only 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, rapid immunoassay for qualitative detection of Oxazepam in human urine; 300 ng/mL cutoff. Device used in laboratory settings by professional personnel. Input: human urine sample. Principle: competitive binding immunoassay; visual readout. Output: qualitative visual result (positive/negative). Preliminary result requires clinical judgment and confirmation via GC/MS. Benefits: rapid screening for benzodiazepine presence.

Clinical Evidence

No clinical studies were performed. Performance was evaluated via method comparison against GC/MS using 130 clinical urine samples (70 negative, 60 positive). Results showed 100% agreement for samples <50% of cutoff and >50% above cutoff, with 63% and 68% agreement for near-cutoff negative and positive samples, respectively. Analytical performance included precision/reproducibility studies across four sites and cross-reactivity testing against various structurally related compounds and common interfering substances.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: membrane strip pre-coated with oxazepam-protein conjugate, wicking pad with anti-benzodiazepine monoclonal antibody-colloidal gold conjugate. Single-use, visually read. No external energy source or connectivity. Stability: 2 years at 15–30 °C.

Indications for Use

Indicated for the qualitative detection of Oxazepam in human urine at a 300 ng/mL cutoff. Intended for laboratory use only to provide preliminary results. Requires confirmation by alternate chemical methods, preferably GC/MS.

Regulatory Classification

Identification

A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A benzodiazepine 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

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Public Heath Searce

JUL 2 8 2006

Food and Dr. a Administras 2098 Galber Road Rockville MD 20850

Dr. Gregory Lee Acro Biotech. LLC. 9500 7" Street Unit M Rancho Cucamonga, CA 91730

Re: k060354 Trade/Device Name: Acro Rapid Benzodiazepine Urine Test Regulation Number: 21 CFR8862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: Class II Product Code: JXM Dated: June 12, 2006 Received: July 14, 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).

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

Sincerely yours,

Albert G. A.

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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### FDA INDICATIONS FOR USE FORM

# 510(K) NUMBER (IF KNOWN) k060354

Acro Rapid Benzodiazepine Urine Test Device Name:

#### Indications for Use

Acro Rapid Benzodiazepine Urine Test is a lateral flow, rapid immunoassay for the qualitative Acro Rapid Oxazepam in human urine at a cutoff of 300 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 mast be applied to a more specific al result, a more specific alternate chemical method is needed. Gas Chromatography/ Mass Spectroscopy (GC/MS) analysis is preferred.

> Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

acting

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