CARE FECAL OCCULT BLOOD TEST, MODEL KT313

K051806 · Epitope Diagnostics, Inc. · KHE · Oct 3, 2005 · Hematology

Device Facts

• Record ID: K051806
• Device Name: CARE FECAL OCCULT BLOOD TEST, MODEL KT313
• Applicant: Epitope Diagnostics, Inc.
• Product Code: KHE · Hematology
• Decision Date: Oct 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

Intended Use

Epitope Diagnostics CARE™ Fecal Occult Blood Test Device is a rapid immunological test intended for the qualitative detection of fecal occult blood in feces by professional laboratories and physician office laboratories. The test is intended for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer. The CARE™ Fecal Occult Blood Test Device is recommended for use in (1) routine physical examinations, (2) monitoring any bleeding in patients, and (3) screening for colorectal cancer or gastrointestinal bleeding.

Device Story

Rapid lateral flow immunoassay for qualitative detection of human hemoglobin in feces; utilizes two monoclonal antibodies (MAbs) to detect human hemoglobin (hHb) at concentrations >50 ng/mL. Sample collection device extracts fecal sample into buffer; extract migrates via capillary action through test strip. Presence of hHb forms immuno-complex with labeled and membrane-immobilized MAbs, producing red colored band in test region. Procedural control band confirms test validity. Used in professional laboratories and physician office laboratories (POLs) by trained staff. Results interpreted visually by healthcare provider to identify GI bleeding associated with conditions like diverticulitis, colitis, polyps, or colorectal cancer. Assists clinical decision-making by identifying need for further diagnostic investigation.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Rapid immunological test for qualitative detection of fecal occult blood. Form factor is a test device for laboratory use. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for routine physical examinations, monitoring bleeding in patients, and screening for colorectal cancer or gastrointestinal bleeding in patients requiring fecal occult blood testing.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 3 - 2005

Ping Gao, M.D. President Epitope Diagnostics, Inc. 7955 Dunbrook Road, Suite B San Diego, CA 92126

k051806 Re: Trade/Device Name: CARE™ Fecal Occult Blood Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: KHE Dated: August 23, 2005 Received: August 24, 2005

Dear Dr. Gao:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave reviewed your your your 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 conimers 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). and coomers of exerce, 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 r rease of acrised a determination that your device complies with other requirements of the Act than x D rederal statutes and regulations administered by other Federal agencies. You must or any I 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) I ms letter will and not for your finding of substantial equivalence of your device to a legally promated riedicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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). 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 yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, P& 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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## Indications for Use

510(k) Number (if known): K051806

Device Name: CARE™ Fecal Occult Blood Test

## Indications for Use:

Epitope Diagnostics CARE™ Fecal Occult Blood Test Device is a rapid immunological test intended for the qualitative detection of fecal occult blood in feces by professional laboratories and physician office laboratories. The test is intended for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer.

The CARE™ Fecal Occult Blood Test Device is recommended for use in (1) routine physical examinations, (2) monitoring any bleeding in patients, and (3) screening for colorectal cancer or gastrointestinal bleeding.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Kosim6 - 1.4.1 -