CARE FECAL OCCULT BLOOD TEST, MODEL KT313 by EPITOPE DIAGNOSTICS, INC.

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 Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for the CARE™ Fecal Occult Blood Test. However, it does not contain the acceptance criteria or a study description with the level of detail requested in the prompt.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not present the specific performance metrics (sensitivity, specificity, etc.) nor the details of any clinical or analytical study performed to prove this equivalence. The letter refers to "indications for use stated in the enclosure," but the enclosure provided focuses only on the "Indications for Use" statement and not the performance data.

Therefore, I cannot fully answer your request using only the provided text. I can, however, extract the information that is present:

Indications for Use (from the enclosure):
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 following information is NOT available in the provided document:

A table of acceptance criteria and the reported device performance: This information would typically be found in a summary of safety and effectiveness data, which is not part of this approval letter.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a rapid immunological test, not an AI-based imaging or diagnostic tool. Therefore, an MRMC study with human readers and AI assistance would not be applicable.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable for this type of test.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

To obtain the detailed information regarding acceptance criteria and study results, one would typically need to review the 510(k) summary document or the full 510(k) submission, which are usually publicly available on the FDA website for cleared devices.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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:

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 -

Regulation Number and Section

§ 864.6550 Occult blood test.

(a)
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.)(b)
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.