GENIE CUP INTEGRATED SCREENING DEVICE

K980836 · Applied Technology Ventures, LLC · LDJ · Jun 29, 1998 · Clinical Toxicology

Device Facts

• Record ID: K980836
• Device Name: GENIE CUP INTEGRATED SCREENING DEVICE
• Applicant: Applied Technology Ventures, LLC
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Jun 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The Genie Cup™ Integrated Screening Device is a professional use, rapid, multiple immunoassay tool for the qualitative detection of the major metabolites of drugs of abuse in urine at the SAMHSA specified (except for methamphetamines) cutoff concentrations. Genie Cup™ Integrated Screening Device provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Story

Genie Cup™ Integrated Screening Device is a professional-use, rapid, multiple immunoassay diagnostic tool. It accepts urine samples to detect major metabolites of drugs of abuse. The device utilizes immunoassay technology to provide preliminary qualitative analytical results based on specific cutoff concentrations for amphetamines, cocaine, opiates, phencyclidine, cannabinoids, and methamphetamines. It is intended for use in clinical settings by healthcare professionals. The output is a preliminary test result; clinical judgment and confirmatory testing (e.g., GC/MS) are required for definitive diagnosis. The device assists clinicians in rapid screening, facilitating timely clinical decision-making regarding substance use.

Clinical Evidence

No clinical data provided; the submission relies on analytical performance characteristics for an in vitro diagnostic screening device.

Technological Characteristics

The device is a rapid, multiple immunoassay screening tool for urine analysis. It operates via immunochemical binding principles to detect drug metabolites at specified cutoff concentrations. It is a standalone, professional-use diagnostic device.

Indications for Use

Indicated for professional use as a rapid, qualitative, multiple immunoassay screening tool for the detection of drug metabolites in urine. Target analytes and cutoff concentrations: amphetamines (1000 ng/ml), cocaine (300 ng/ml), opiates (300 ng/ml), phencyclidine (PCP) (25 ng/ml), cannabinoids (THC) (50 ng/ml), and methamphetamines (500 ng/ml).

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 9 1998

Dr. Richard Roblin Chief Scientific Officer Point of Care Technologies, Inc. 6 Taft Court, Suite 150 Rockville, Maryland 20850

Re : K980836 Genie Cup™ Integrated Screening Device Requlatory Class: II Rogarat Code: LDJ, DIO, DJG, DKZ, LCM Dated: May 22, 1998 Received: May 22, 1998

Dear Dr. Roblin:

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 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 The general controls provisions of the Act 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 requlations 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 In addition, FDA may publish further announcements action. 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 leqally 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/dsmamain.html".

Sincerely yours,
Steven Litman

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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N 480056.171

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长980836 510(k) Number (if known):

Genie Cup™ Integrated Screening Device Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| methamphetamines | 500 ng/ml | | | |

Genie Cup™ Integrated Screening Device provides only a preliminary analytical test result. A more Gente Cup - Integrated Screening Dors be used in order to obtain a confirmed analytical i Clici Specific aller nate chemical metry (GC/MS) is the preferred confirmatory method. Clinical Gas chi onliness apliyations on indigement should be applied to any drug of abuse test result, consider attorrand preliminary positive results are used.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | <img alt="signature" src=""/> Alfred Montgome |
|--------------------------------------------------------|-----------------------------------------------|
| (Division Sign-Off) | Cawl Denam |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K980836 |

| Prescription Use <img alt="check" src=""/> | OR | Over-The-Counter Use_ |
|--------------------------------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |

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