ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000

K992422 · Princeton BioMeditech Corp. · DJG · Aug 10, 1999 · Clinical Toxicology

Device Facts

• Record ID: K992422
• Device Name: ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000
• Applicant: Princeton BioMeditech Corp.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Aug 10, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3650
• 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 amphetamine in human urine to assist in the screening of druse samples. The detection cut-off concentrations are as follows: MET d-Methamphetamine 1000 ng/mL OPI Morphine 2000 ng/mL COC Benzoylecgonine 300 ng/mL THC 11-nor-Δ9-9-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 series are immunoassay-based diagnostic tests for qualitative detection of drugs of abuse in human urine. Devices utilize specific cut-off concentrations for analytes including methamphetamine, opiates, cocaine, THC, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, and methadone. Intended for professional, prescription-use screening in clinical settings. Healthcare providers interpret visual results to assist in identifying potential drug presence. Results provide preliminary screening data to guide clinical decision-making regarding further confirmatory testing or patient management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunoassay-based qualitative drug screening test. Form factor is a diagnostic test device for human urine analysis. Operates via chemical detection at specified ng/mL cut-off concentrations for various drug analytes. Professional, prescription-use only.

Indications for Use

Indicated for qualitative detection of drugs of abuse (methamphetamine, opiates, cocaine, THC, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, amphetamine) in human urine for professional, prescription-use screening.

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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AUG 10 1999

Mr. Jemo Kang, Ph.D. Director Princeton BioMeditech Corp. 4242 U.S. RT. 1 Monmouth Junction, New Jersey 08852

Re: K992422

> Trade Name: AccuSign® DOA3 AccuSign® DOA4 AccuSign® DOA5 AccuSign® DOA8 AccuSign®DOA10 Regulatory Class: II Product Code: DJG Dated: July 20, 1999 Received: July 21, 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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Image /page/0/Picture/9 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted as a series of curved lines that form a shape resembling a bird or a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/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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# J(k) Number (if known): ______________________________________________________________________________________________________________________________________________________

Device Name: _ AccuSign® DQA 10 (MET/OPI//COC/THC/PCP/BZQ/BAR/MTD/TCA/AMP) Indications For Use:

Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and amphetamine in human urine to assist in the screening of druse samples. The detection cut-off concentrations are as follows:

| MET | d-Methamphetamine | 1000 ng/mL |
|----------------|-----------------------------|------------|
| OPI | Morphine | 2000 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| THC | 11-nor-Δ9-9-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 |

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Concurrence of CDRH Office of Device Evaluation (ODE)

Professional Use:_X___________________________________________________________________________________________________________________________________________________________ Prescription Use:_X (Per 21 CFR 801.109)

OR

Over The Counter Use:

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| Page | 1 |
|------|---|
|------|---|

,10(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples.

### (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 'er 21 CFR 801.109)

OR

Over The Counter Use: _ _ _________

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-10(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Levice Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Immunoassay for the qualitative detection of THC, opiates, cocaine, methamphetamine (or amphetamine), phencyclidine and/or their metabolites in human urine to assist in screening of drug of abuse samples.

. .

#### (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 ___ (Per 21 CFR 801.109)

OR

Over The Counter Use: ______________

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| Page | 1 of 1 |
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'0(k) Number (if known): _ K 9 92422

Device Name:___ AccuSign® DOA 4 (THC/OPI200)COC/MET or AMP)

Indications For Use:

Immunoassay for the qualitative detection of THC, opiates, cocaine, methamphetamine (or amphetamine), and/or their metabolites in human urine to assist in screening of drug of abuse samples.

## (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 (Per 21 CFR 801.109)

OR

Over The Counter Use: ________________________________________________________________________________________________________________________________________________________

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J(k) Number (if known): ______________________________________________________________________________________________________________________________________________________ Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Immunoassay for the qualitative detection of THC, opiates, cocaine, and/or their metabolites in human urine to assist in screening of drug of abuse samples.

Sean Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices K 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 (Per 21 CFR 801.109)

OR

Over The Counter Use: ________________________________________________________________________________________________________________________________________________________

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9(k) Number (if known): ______________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Immunoassay for the qualitative detection of amphetamine or methamphetamine, opiates, of abuse Immunoassay for the qualitative detection of anyman urine to assist in screening of drugs of abuse
metabolites, THC metabolites, and phencyclidine in human urine to assist in niciabonici), 1999-19-19
samples. The detecting cut-off concentrations are as follows:

| THC | 11-nor-Δ9-9-carboxylic acid | 50 ng/mL |
|-----|-----------------------------|------------|
| OPI | Morphine | 2000 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| AMP | Amphetamine | 1000 ng/mL |
| MET | D-Methamphetamine | 1000 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |

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

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Concurrence of CDRH Office of Device Evaluation (ODE)

Professional Use:_X____ Prescription Use:_X (Per 21 CFR 801.109)

OR

Over The Counter Use: ________________________________________________________________________________________________________________________________________________________