DBEST ONE STEP OCCULT BLOOD TEST KITS

K071242 · Ameritek USA, Inc. · KHE · Mar 6, 2008 · Hematology

Device Facts

• Record ID: K071242
• Device Name: DBEST ONE STEP OCCULT BLOOD TEST KITS
• Applicant: Ameritek USA, Inc.
• Product Code: KHE · Hematology
• Decision Date: Mar 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

Intended Use

dBest One Step Occult Blood Test Kits is a simple immunochromatographic assay for rapid, qualitative detection of fecal occult blood by laboratories or physicians office. It is useful as a diagnostic test kit to aid for detection of bleeding caused by a number of gastrointestinal disorders, such as diverticulitis, colitis, polyps and colorectal cancer. dBest One Step Occult Blood Test Kit is recommended for use in 1) Routine physical examinations, 2) Hospital monitoring for gastrointestinal bleeding and 3) Screening for colorectal cancer

Device Story

dBest One Step Occult Blood Test Kit is an immunochromatographic assay for qualitative detection of fecal occult blood. Device used in laboratories or physician offices to aid in diagnosing gastrointestinal disorders including diverticulitis, colitis, polyps, and colorectal cancer. Operates via lateral flow immunoassay principle; detects presence of blood in fecal samples. Provides rapid visual qualitative results to healthcare providers. Assists clinical decision-making by identifying occult bleeding, facilitating further diagnostic investigation for potential GI pathology.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lateral flow immunochromatographic assay. Components: sampling bottle with extraction buffer, test cassette with nitrocellulose membrane, and mouse anti-hHb antibody-colloidal gold conjugate. Detection limit: 10 ng/ml hHb in stool. Procedural control: goat/rabbit anti-mouse IgG line. Visual readout.

Indications for Use

Indicated for rapid, qualitative detection of fecal occult blood in patients undergoing routine physical exams, hospital monitoring for GI bleeding, or colorectal cancer screening. Used by laboratories or physician offices.

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)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple, using only black and white, which gives it a clean and official appearance.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR - 6 2008

Ameritek USA, Inc. c/o K.C. Yee 125 130th Street SE Everett, Washington 98208

Re: k071242

Trade/Device Name: dBest One Step Occult Blood Test Kit Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: KHE Dated: May 1, 2007 Received: May 22, 2007

Dear K.C. Yee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Robert Bradley

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indication for Use

510(k) Number (if known) K071242

Device Name: dBest One Step Occult Blood Test Kits

Indication For Use: dBest One Step Occult Blood Test Kits is a simple immunochromatographic assay for rapid, qualitative detection of fecal occult blood by laboratories or physicians office. It is useful as a diagnostic test kit to aid for detection of bleeding caused by a number of gastrointestinal disorders, such as diverticulitis, colitis, polyps and colorectal cancer. dBest One Step Occult Blood Test Kit is recommended for use in 1) Routine physical examinations, 2) Hospital monitoring for gastrointestinal bleeding and 3) Screening for colorectal cancer

X Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Josephine Bautista

Division/Sign/Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K071242

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