(90 days)
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No
The summary describes a rapid immunological test for detecting fecal occult blood, which is a chemical/biological assay and does not mention any computational or image processing components typically associated with AI/ML in medical devices.
No.
The device is a qualitative diagnostic test for detecting blood in feces, which aids in identifying gastrointestinal bleeding and disorders, but it does not treat or cure any medical condition.
Yes
Explanation: The device is intended for the qualitative detection of fecal occult blood to determine gastrointestinal bleeding and for screening for colorectal cancer or gastrointestinal bleeding, which are diagnostic purposes.
No
The 510(k) summary describes a "Fecal Occult Blood Test Device," which is a rapid immunological test. This description strongly implies a physical test kit or device that interacts with a biological sample (feces), not a software-only product. The lack of any mention of software, algorithms, or digital processing further supports this conclusion.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "rapid immunological test intended for the qualitative detection of fecal occult blood in feces." This involves testing a sample taken from the body (feces) in vitro (outside the body) to diagnose or provide information about a medical condition (gastrointestinal bleeding).
- Sample Type: The test uses "feces," which is a biological sample taken from the human body.
- Purpose: The purpose is to determine "gastrointestinal (GI) bleeding" and aid in the diagnosis of various GI disorders, including colorectal cancer. This aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Care Setting: The test is intended for use in "professional laboratories and physician office laboratories," which are typical settings for IVD testing.
The description clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
KHE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
professional laboratories and physician office laboratories.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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:
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 -