DBEST OCCULT BLOOD TEST KIT

K984269 · Ameritek, Inc. · KHE · May 11, 1999 · Hematology

Device Facts

• Record ID: K984269
• Device Name: DBEST OCCULT BLOOD TEST KIT
• Applicant: Ameritek, Inc.
• Product Code: KHE · Hematology
• Decision Date: May 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

Intended Use

dBest Sensitive Occult Blood Test Kit is a simple in-vitro guaiac slide test assay for the rapid, qualitative detection of human occult blood in feces, as a useful aid for detection of bleeding caused by a number of gastrointestinal disorders. The dBest Sensitive Occult Blood Test Kit is for clinical situations and professional laboratory use only.

Device Story

The dBest Sensitive Occult Blood Test Kit is an in-vitro diagnostic device used in clinical and professional laboratory settings. It utilizes a guaiac slide test assay to detect human occult blood in fecal samples. The test provides a rapid, qualitative result to assist healthcare providers in identifying gastrointestinal bleeding. By detecting occult blood, the device aids in the clinical evaluation of various gastrointestinal disorders, allowing for timely diagnostic decision-making and patient management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In-vitro guaiac slide test assay for fecal occult blood detection. Professional laboratory use only.

Indications for Use

Indicated for professional clinical and laboratory use for the rapid, qualitative detection of human occult blood in feces to aid in the diagnosis of gastrointestinal disorders associated with bleeding. No specific age or gender restrictions provided.

Regulatory Classification

Identification

An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

Special Controls

*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 1 1999

AmeriTek, Inc. C/O K.C. Yee. M.D., Ph.D. President and CEO 7030 35th Avenue, N.E. Seattle, Washington 98115

K984269 Re:

Trade Name: AmeriTek dBest Sensitive Occult Blood Test Kit Regulatory Class: II Product Code: KHE Dated: February 14, 1999 Received: February 22, 1999

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 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 Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.

{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/dsma/dsmamain.html".

Sincerely yours,

Steven Gutman

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}------------------------------------------------

of Page

510 (K) Number (if known): K 984269

Device Name: dBest Sensitive Occult Blood Test Kit

Indications For Use:

dBest Sensitive Occult Blood Test Kit is a simple in-vitro guaiac slide test assay for the rapid, qualitative detection of human occult blood in feces, as a useful aid for detection of bleeding caused by a number of gastrointestinal disorders. The dBest Sensitive Occult Blood Test Kit is for clinical situations and professional laboratory use only.

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

Peter E. Mafem

Laboratory Devic

Prescription Use V

OR

Over-The -Counter Use (Optional Format 1-2-96)