DBEST COCAINE TEST KIT

K983191 · Ameritek, Inc. · DIO · Nov 18, 1998 · Clinical Toxicology

Device Facts

• Record ID: K983191
• Device Name: DBEST COCAINE TEST KIT
• Applicant: Ameritek, Inc.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Intended Use

dBest Cocaine Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of cocaine and primarily benzoylecgonine as metabolites in urine with cutoff of 300 ng/ml. The dBest Cocaine Test Kits are for professional and laboratory use only.

Device Story

dBest Cocaine Test Kit is a lateral flow immunochromatographic assay; utilizes urine samples; detects cocaine and benzoylecgonine metabolites; cutoff concentration 300 ng/ml. Designed for professional and laboratory use; provides rapid qualitative results. Assists healthcare providers in identifying cocaine presence in urine specimens.

Clinical Evidence

No clinical data provided; device performance is based on analytical bench testing for qualitative detection of cocaine metabolites in urine.

Technological Characteristics

Immunochromatographic assay (lateral flow); qualitative detection; 300 ng/ml cutoff; urine specimen matrix.

Indications for Use

Indicated for professional and laboratory use for the rapid, qualitative detection of cocaine and benzoylecgonine metabolites in human urine at a 300 ng/ml cutoff concentration.

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows a partial view of a logo or emblem. The visible portion features a stylized, abstract design consisting of three curved, overlapping shapes that resemble a caduceus. The word "DEPARTMENT" is partially visible, oriented vertically along the left edge of the image.

NOV 18 K

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

K. C. Yee, Ph.D. President AmeriTek, Inc. Diagnostic Division 7030 30th Avenue, N.E. Seattle, Washington 98115

K983191 Re: dBest Cocaine Test Kit Trade Name: Requlatory Class: II Product Code: DIO September 10, 1998 Dated: Received: September 11, 1998

Dear Dr. Yee:

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 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 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.

{1}------------------------------------------------

Page 2

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/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

{2}------------------------------------------------

Page of

## 510 (K) Number (if know): K 98319 |

Device Name: dBest Cocaine Test Kits

Indications For Use:

dBest Cocaine Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of cocaine and primarily benzoylecgonine as metabolites in urine with cutoff of 300 ng/ml. The dBest Cocaine Test Kits are for professional and laboratory use only.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K983191

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PATE IF NEEDEN)

Prescription Use OR Over-The -Counter Use (Optional Format 1-2-96) ﺮ .