FINGERPRINT DRUG SCREENING DEVICE

K973726 · Applied Technology Ventures, LLC · DKZ · Nov 6, 1997 · Clinical Toxicology

Device Facts

• Record ID: K973726
• Device Name: FINGERPRINT DRUG SCREENING DEVICE
• Applicant: Applied Technology Ventures, LLC
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Nov 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The FINGERPRINT Drug Screening Device™ is a professional use, rapid, multiple immunoassay test for the qualitative determination of the major metabolites of the following drugs of abuse in human urine at the National Institute on Drug Abuse (NIDA) specified cutoff concentrations. AMP amphetamines 1000 ng/ml COC cocaine 300 ng/ml MOR opiates 300 ng/ml PCP phencyclidine 25 ng/ml THC cannabinoids 50 ng/ml FINGERPRINT Drug Screening Device™ test provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical test result. Gas chromatography/mass spectrometry (GCMS) is the preferred confirmed analytical result. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Story

The Fingerprint Drug Screening Device is a rapid, professional-use, multiple immunoassay test for qualitative detection of drug metabolites in human urine. It utilizes immunoassay technology to detect amphetamines, cocaine, opiates, phencyclidine, and cannabinoids at NIDA-specified cutoff concentrations. The device is intended for use by healthcare professionals in clinical settings. It provides preliminary analytical results; positive findings require confirmation via more specific methods, such as gas chromatography/mass spectrometry (GC/MS). Clinical judgment must be applied to all results. The device aids in the preliminary screening of individuals for drugs of abuse.

Clinical Evidence

No clinical data provided; device relies on analytical performance at NIDA-specified cutoff concentrations.

Technological Characteristics

Rapid, multiple immunoassay test for qualitative detection of drug metabolites in human urine. Operates via immunoassay principles. Designed for professional use.

Indications for Use

Indicated for professional use as a rapid, qualitative immunoassay for the detection of drug metabolites (amphetamines, cocaine, opiates, phencyclidine, cannabinoids) in human urine at NIDA-specified cutoff concentrations. Provides preliminary results requiring confirmation by alternate chemical methods (e.g., GC/MS).

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine 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

NOV - 6 1997

Dr. Richard Roblin . Chief Scientific Officer Point of Care Technologies, Inc. 2190 Fox Mill Road Herdon, Virginia 20171

Re: K973726 Fingerprint Drug Screening Device™ Requlatory Class: II Product Code: DKZ, DIO, DJG, LDJ, LCM Dated: September 30, 1997 Received: September 30, 1997

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 Requlations, 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 Requlation (QS) for Medical Devices: General requlation (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 requlations.

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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 requlation 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.qov/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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Page________of_

K973726 510(k) Number (if known):

FINGERPRINT Drug Screening Device™ Device Name:

Indications For Use:

## Intended Use

The FINGERPRINT Drug Screening Device™ is a professional use, rapid, multiple immunoassay test for the qualitative determination of the major metabolites of the following drugs of abuse in human urine at the National Institute on Drug Abuse (NIDA) specified cutoff concentrations.

| AMP | amphetamines | 1000 ng/ml |
|-----|---------------|------------|
| COC | cocaine | 300 ng/ml |
| MOR | opiates | 300 ng/ml |
| PCP | phencyclidine | 25 ng/ml |
| THC | cannabinoids | 50 ng/ml |

FINGERPRINT Drug Screening Device™ test provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical test result.
result. Gas chromatographylmass snoctronotes result. Gas chromatography/mass spectrometry (GCMS) is the preferred confirmed analytical
Clinical consideration and professional indexs Clinical consideration and professional judgement should be applied to any drug of abod.
particularly when preliminary nositive results on any drug of abuse test result, particularly when 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)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|--------------------------|
| | | (Optional Format 1-2-96) |

(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | |
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