ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/

K983501 · Princeton BioMeditech Corp. · LAG · Dec 18, 1998 · Clinical Toxicology

Device Facts

• Record ID: K983501
• Device Name: ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/
• Applicant: Princeton BioMeditech Corp.
• Product Code: LAG · Clinical Toxicology
• Decision Date: Dec 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Intended Use

Immunoassay for the qualitative detection of methamphetamine, opiates. cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and medionein, phonoyoneans, on assist in screening of drug of abuse samples. The detecting cut-off concentrations are as follows: MET D-Methamphetamine 1000 ng/mL OPI Morphine 300 ng/mL COC Benzoylecgonine 300 ng/mL THC 11-nor-Δ 9-9-carboxylic acid 50 ng/mL PCP Phencyclidine 25 ng/mL Benzodiazepine Oxazepam 300 ng/mL Barbiturate Secobarbital 300 ng/mL Methadone Methadone 300 ng/mL TCA Nortriptyline 1000 ng/mL

Device Story

AccuSign DOA 10 is an immunoassay test kit for qualitative screening of drugs of abuse. The device processes human samples to detect specific drug metabolites (methamphetamine, opiates, cocaine, THC, PCP, benzodiazepines, barbiturates, tricyclic antidepressants, methadone) based on defined cut-off concentrations. It is intended for professional, prescription-based clinical use. The device provides visual qualitative results to assist healthcare providers in screening for drug presence, facilitating clinical decision-making regarding patient substance use status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic immunoassay kit. Qualitative detection based on specific cut-off concentrations for drug metabolites. Professional use format.

Indications for Use

Indicated for the qualitative screening of drugs of abuse in human samples to assist in detection of methamphetamine, opiates, cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, and methadone at specified cut-off concentrations. For professional, prescription use.

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)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 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-like figure, composed of three curved lines that suggest wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

DEC 1 8 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Jemo Kang, Ph.D., M.B.A. Director Princeton BioMeditech Corporation P.O. Box 7139 Princeton, NJ 08543-7139

Re: K983201

> Trade Name: AccuSign® DOA 10, AccuSign DOA Panel, AccuSign MET/OPI/ COC/THC/PCP/BZO/BAR/MTD/TCA/AMP Regulatory Class: II Product Code: LAG,DJG,DIO,DKE,LCM,DIS,DKN,DJR,LFI and DKZ Dated: October 5, 1998 Received: October 6, 1998

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. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act). or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice. and 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 Butman

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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## K9835 510(k) Number (if known): __

# ice Name:__AccuSign®DOA 10 (MET/QPI/COC/THC/PCP/BZO/BARMTD/TCA/AMP)

Indications For Use:

Immunoassay for the qualitative detection of methamphetamine, opiates. cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and medionein, phonoyoneans, on assist in screening of drug of abuse samples. The detecting cut-off concentrations are as follows:

| MET | D-Methamphetamine | 1000 ng/mL |
|----------------|------------------------------|------------|
| OPI | Morphine | 300 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| THC | 11-nor-Δ 9-9-carboxylic acid | 50 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
| Benzodiazepine | Oxazepam | 300 ng/mL |
| Barbiturate | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| TCA | Nortriptyline | 1000 ng/mL |

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Concurrence of CDRH Office of Device Evaluation (ODE)

| | <center> <div style="border-bottom: 1px solid black;"></div> (Division Sign-Off) Division of Clinical Laboratory Devices </center> |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | ____________________ |
| Professional Use: | X |
| Prescription Use: | X |
| (Per 21 CFR 801.109) | |

OR

| Over The Counter Use: | ____________________ |
|-----------------------|----------------------|
|-----------------------|----------------------|

(Optional Format 1-2-96)