STATUS CUP ACCUSIGN CUP

K991751 · Princeton BioMeditech Corp. · DKE · Jun 18, 1999 · Clinical Toxicology

Device Facts

• Record ID: K991751
• Device Name: STATUS CUP ACCUSIGN CUP
• Applicant: Princeton BioMeditech Corp.
• Product Code: DKE · Clinical Toxicology
• Decision Date: Jun 18, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

Immunoassay for the qualitative detection of amphetamine, THC metabolites, methamphetamine, opiates, and phencyclidine in human urine to assist in screening of drugs of abuse samples. The detecting cut-off concentrations are as follows: AMP Amphetamine 1000 ng/mL THC 11-nor-A9-9-carboxylic acid 50 ng/mL COC Benzoylecgonine 300 ng/mL MET D-Methamphetamine 1000 ng/mL OPI Morphine 300 ng/mL PCP Phencyclidine 25 ng/mL

Device Story

Status Cup is an in vitro diagnostic immunoassay device for qualitative screening of drugs of abuse in human urine. Input is a human urine sample; device utilizes immunoassay technology to detect presence of amphetamine, THC metabolites, methamphetamine, opiates, and phencyclidine at specified cut-off concentrations. Output is a visual qualitative result indicating presence or absence of target analytes. Used in clinical or professional settings; operated by healthcare professionals. Results assist clinicians in screening for drug use; provides rapid preliminary information to guide further clinical decision-making or confirmatory testing.

Clinical Evidence

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

Technological Characteristics

In vitro diagnostic immunoassay; qualitative detection via visual interpretation of test results at defined cut-off concentrations (ng/mL).

Indications for Use

Indicated for the qualitative detection of amphetamine, THC metabolites, methamphetamine, opiates, and phencyclidine in human urine for the screening of drugs of abuse. Intended for professional and prescription use.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 18 1999

Jemo Kang, Ph.D., M.B.A. Director Princeton BioMeditech Corporation 4242 U.S. Route 1 Monmouth Junction, New Jersey 08852-1905

Re: K991751

> Trade Name: Status Cup™ - AMP/THC/COC/MET/OPI/PCP Regulatory Class: II Product Code: DKE, DIO, LAG, DJG, LCM, DKZ Dated: May 15, 1999 Received: May 24, 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 [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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Page_of_of_of_________________________________________________________________________________________________________________________________________________________________

2(k) Number (if known): _ 1 9 1 75

Device Name:___Status Cup_

Indications For Use:

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

| AMP | Amphetamine | 1000 ng/mL |
|-----|-----------------------------|------------|
| THC | 11-nor-A9-9-carboxylic acid | 50 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| MET | D-Methamphetamine | 1000 ng/mL |
| OPI | Morphine | 300 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |

JeanCooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991751

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Concurrence of CDRH Office of Device Evaluation (ODE)

Professional Use:_X Prescription Use:_X 'Per 21 CFR 801.109)

OR

(Optional Format 1-2-96)