ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO

K991079 · Princeton BioMeditech Corp. · JXM · Apr 15, 1999 · Clinical Toxicology

Device Facts

• Record ID: K991079
• Device Name: ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO
• Applicant: Princeton BioMeditech Corp.
• Product Code: JXM · Clinical Toxicology
• Decision Date: Apr 15, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3170
• Device Class: Class 2

Intended Use

Immunoassay for the qualitative detection of benzodiazepines and/or their metabolites in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drug.

Device Story

AccuSign® BZO is an immunoassay for qualitative detection of benzodiazepines and/or their metabolites in human urine. Device assists in screening drug of abuse samples and diagnosing clinical symptoms related to drug use. Intended for professional, prescription use in clinical settings. Operates via immunoassay principles to provide qualitative results to healthcare providers, aiding clinical decision-making regarding drug exposure or abuse.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Immunoassay for qualitative detection of benzodiazepines in human urine. Professional, prescription-use device.

Indications for Use

Indicated for the qualitative detection of benzodiazepines and/or their metabolites in human urine. Used for screening drug of abuse samples and assisting in the diagnosis of clinical symptoms associated with drug use. Intended for professional, prescription use.

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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APR 15 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jemo Kang, Ph.D. President Princeton BioMeditech Corporation 4242 U.S. Route 1 Monmouth Junction, NJ 08852-1905

Re: K991079 Trade Name: AccuSign® BZO Regulatory Class: II Product Code: JXM Dated: March 22, 1999 Received: March 26, 1999

Dear Dr. Kang:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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(k) Number (if known): <991079

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

……

Immunoassay for the qualitative detection of benzodiazepines and/or their metabolites in human urine to assist in screening of drug of abuse samples and/or diagnosis of clinical symptoms associated with the use of drug.

Dean Cooper

Laboratory Devices ivision of Clinical 510(k) Number

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Professional Use:_X Prescription Use:_X r 21 CFR 801.109)

OR

Over The Counter Use: ________

(Optional Format 1-2-96)

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