(88 days)
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No
The summary describes a standard immunochromatographic assay for detecting human hemoglobin in feces. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is an immunochromatographic assay intended for the determination of human hemoglobin in feces to detect gastrointestinal bleeding and related disorders. Its purpose is diagnostic (determining, screening), not therapeutic (treating or curing).
Yes
The device is described as an "immunochromatographic assay intended for the determination of human hemoglobin in feces," which aids in "determining gastrointestinal bleeding" and can be used for "screening for colorectal cancer or gastrointestinal bleeding from any source," all indicative of a diagnostic purpose.
No
The device description clearly states it is an "immunochromatographic assay," which is a physical test kit, not software.
Based on the provided information, the Teco Rapid Fecal Occult Blood (FOB) Card Test is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "determination of human hemoglobin in feces." This involves testing a sample taken from the body (feces) outside of the body (in vitro) to provide information about a person's health.
- Device Description: It's described as an "immunochromatographic assay," which is a common type of test performed in a laboratory setting on biological samples.
- Intended User / Care Setting: It's intended for "professional laboratories or physicians offices," which are typical settings for performing IVD tests.
The core function of the device is to analyze a biological sample (feces) to detect a specific substance (human hemoglobin) to aid in the diagnosis or monitoring of medical conditions (gastrointestinal bleeding, colorectal carcinoma, etc.). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Teco Rapid Fecal Occult Blood (FOB) Card Test is an immunochromatographic assay intended for the determination of human hemoglobin in feces by professional laboratories or physicians offices. It is useful to determining gastrointestinal bleeding found in a number of gastrointestinal disorders such as colorectal carcinoma, colon polyps, diverticulitis and ulcerative colitis.
Teco Rapid Fecal Occult Blood (FOB) Card Test is recommended for use in 1) routine physical examination 2) hospital monitoring for bleeding in patients, 3) screening for colorectal cancer or gastrointestinal bleeding from any source.
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 or physicians offices
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 4 2006
Mr. Jian Vaeches R & D Department Teco Diagnostics 1268 N. Lakeview Avenue Anaheim, California 92807
Re: K061065
Trade/Device Name: Teco Rapid Fecal Occult Blood (FOB) Card Test Regulation Number: 21 CFR § 864.6550 Regulation Name: Occult blood test Regulatory Class: II Product Code: KHE Dated: May 26, 2006 Received: June 7, 2006
Dear Mr. Vaeches:
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. Iisting 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 predicate 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.
lobetz Beckerh
Robert L. Becker, Jr., MD, PX. 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): _ K061065
Device Name: Teco Rapid Fecal Occult Blood (FOB) Card Test
Indications for Use: Teco Rapid Fecal Occult Blood (FOB) Card Test is an immunochromatographic assay intended for the determination of human hemoglobin in feces by professional laboratories or physicians offices. It is useful to determining gastrointestinal bleeding found in a number of gastrointestinal disorders such as colorectal carcinoma, colon polyps, diverticulitis and ulcerative colitis.
Teco Rapid Fecal Occult Blood (FOB) Card Test is recommended for use in 1) routine physical examination 2) hospital monitoring for bleeding in patients, 3) screening for colorectal cancer or gastrointestinal bleeding from any source.
Robert M. Becker
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Prescription Use V
510(k) K06/065
AND/OR
Over-The-Counter Use
(Part 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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