(176 days)
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No
The description focuses on an immunochromatographic assay, which is a chemical/biological test, and does not mention any computational or algorithmic components indicative of AI/ML.
No.
The device is a diagnostic tool used to detect the presence of human hemoglobin in fecal specimens, which can indicate gastrointestinal diseases; it does not provide therapy or treatment.
Yes
The device qualitatively detects human hemoglobin in fecal specimens, which can indicate gastrointestinal diseases, thereby providing information for diagnosis.
No
The device description clearly states it is an "immunochromatographic assay," which is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "qualitative detection of intact hHB (human hemoglobin) in fecal specimens" to help detect "human fecal occult blood, which may be indicative of gastrointestinal diseases associated with bleeding". This involves testing a sample taken from the human body (fecal specimen) to provide information about a person's health status.
- Device Description: The description confirms it's an "immunochromatographic assay for the qualitative detection of intact hHB (human hemoglobin) in fecal specimens," which is a common type of in vitro diagnostic test.
- Sample Type: It uses "fecal specimens," which are biological samples taken from the human body.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The ImmoCARE® test is a rapid, immunochromatographic assay for the qualitative detection of intact hHB (human hemoglobin) in fecal specimens. It is a convenient and hygienic inethod for detecting human fecal occult blood, which may be indicative of gastrointestinal diseases associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans.
ImmoCARE® is an immunological test for both professional and over the counter use.
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 and over the counter use.
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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Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES
Trade/Device Name: ImmoCARE® Regulation Number: 21 CFR § 864.6550 Regulation Name: Reagent Occult Blood
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Re:
Care Diagnostic, Inc. c/o Araceli C. Fancher-Ferreira Official Correspondent 1741 Wiard Street Klamath Falls, OR 97603
16 200
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dated: February 3, 2006 Received: February 9, 2006
Regulatory Class: II Product Code: KHE
Dear Ms Fancher-Ferreira:
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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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
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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: K052598
Device Name: ImmoCARE®
Indications for Use:
The ImmoCARE® test is a rapid, immunochromatographic assay for the qualitative detection of intact hHB (human hemoglobin) in fecal specimens. It is a convenient and hygienic inethod for detecting human fecal occult blood, which may be indicative of gastrointestinal diseases associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans.
ImmoCARE® is an immunological test for both professional and over the counter use..
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use (21 CFR 301 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K052598
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