ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/

K990786 · Princeton BioMeditech Corp. · LAG · Mar 26, 1999 · Clinical Toxicology

Device Facts

• Record ID: K990786
• Device Name: ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/
• Applicant: Princeton BioMeditech Corp.
• Product Code: LAG · Clinical Toxicology
• Decision Date: Mar 26, 1999
• Decision: SESE
• Submission Type: Special
• 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 antidepressans, methadone, and amphetamine in human urine to assist in the screening of drugs of abuse samples. The detection 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-A9-9-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; Amphetamine: d-Amphetamine 1000 ng/mL

Device Story

AccuSign® DOA 10 is an immunoassay device for qualitative detection of ten specific drug classes in human urine. Input: human urine sample. Principle: immunoassay-based screening. Output: visual qualitative result indicating presence or absence of drugs above specified cut-off concentrations. Used in clinical settings to assist in drug of abuse screening. Healthcare providers interpret visual results to inform clinical decision-making regarding patient drug status. Benefits include rapid, point-of-care screening capability.

Clinical Evidence

No clinical data provided; device relies on analytical performance characteristics (cut-off concentrations) for qualitative drug screening.

Technological Characteristics

Immunoassay-based qualitative screening device. Form factor: test device for urine analysis. Analyte detection via specific cut-off concentrations for ten drug classes (MET, OPI, COC, THC, PCP, BZO, BAR, MTD, TCA, AMP).

Indications for Use

Indicated for the qualitative screening of drugs of abuse (methamphetamine, opiates, cocaine, THC, phencyclidine, benzodiazepines, barbiturates, methadone, tricyclic antidepressants, and amphetamine) in human urine samples.

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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Public Health Service

## MAR 26 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K990786

Trade Name: AccuSign® DOA 10, (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: March 8, 1999 Received: March 10, 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.

Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

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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 Gutman

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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Page of of of

## 510(k) Number (if known):_K 99 0 78 €

evice Name:___________________________________________________________________________________________________________________________________________________________________ idications For Use:

Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressans, methadone, and amphetamine in human urine to assist in the screening of drugs of abuse samples. The detection 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-A9-9-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 |
| Amphetamine | d-Amphetamine | 1000 ng/mL |
| | (Division Sign-Off | |

Division of Clinical Laboratory Devices 510(k) Number_K 090786

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

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OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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