(29 days)
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No
The summary describes a qualitative immunochemical test for detecting human hemoglobin in fecal samples, with no mention of AI or ML technologies.
No
The device is a diagnostic test for detecting hemoglobin in fecal samples to screen for gastrointestinal disorders, and it does not provide any therapeutic effect or treatment.
Yes
This device is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples, which serves as a screening aid for detecting lower gastrointestinal disorders, including colorectal cancers or other bleeding lesions. This detection and screening capability for diseases falls under the definition of a diagnostic device.
No
The device is described as a "fecal immunochemical test (FIT)" which is a physical test kit for detecting blood in stool samples. It involves sample collection and laboratory analysis, indicating it is a hardware-based diagnostic test, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that it "qualitatively detects human hemoglobin from blood in fecal samples." This involves testing a sample taken from the human body in vitro (outside the body).
- Sample Type: It uses "fecal samples," which are biological specimens.
- Testing Location: The test is "developed at laboratories or professional offices," which are typical settings for IVD testing.
- Purpose: It is used as a "screening aid for detecting primarily lower gastrointestinal (g.i.) disorders" and "in screening for colorectal cancer or other sources of of our g.i. bleeding." This aligns with the purpose of many IVD devices, which are used for diagnosis, screening, or monitoring of diseases or conditions.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that description.
N/A
Intended Use / Indications for Use
InSure® II FIT is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. The samples will generally be collected by the test subject at home and the test developed at laboratories or professional offices. Fecal immunochemical tests are useful screening aids for detecting primarily lower gastrointestinal (g.i.) disorders that may be related to iron deficiency an onemia, diverticulitis, ulcerative colitis, polyps, adenomas, colorectal cancers or other g.i. lesions that can bleed. Health professionals recommend InSure II for use as part of routine physical examinations and in screening for colorectal cancer or other sources of of our g.i. 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
lower gastrointestinal (g.i.)
Indicated Patient Age Range
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Intended User / Care Setting
test subject at home, laboratories or professional offices, Health professionals
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
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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 seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
ENTERIX, Inc. C/O Edwin Diaz Chief Operating Officer 236 Fernwood Avenue Edison, New Jersey 08837
MAY - 4 2006
Re: K060930
Trade/Device Name: InSure® II Fecal Immunochemical Test (FIT) Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: KHE Dated: 03 April 2006 Received: 05 April 2006
Dear Mr. Diaz:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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,
Robert H. Bedker, Jr.
Robert L. Becker, Jr., MD, PHA 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):
K060930
Device Name:
InSure® II fecal immunochemical test (FIT)
Indications For Use:
InSure® II FIT is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. The samples will generally be collected by the test subject at home and the test developed at laboratories or professional offices. Fecal immunochemical tests are useful screening aids for detecting primarily lower gastrointestinal (g.i.) disorders that may be related to iron deficiency an onemia, diverticulitis, ulcerative colitis, polyps, adenomas, colorectal cancers or other g.i. lesions that can bleed. Health professionals recommend InSure II for use as part of routine physical examinations and in screening for colorectal cancer or other sources of of our g.i. bleeding.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Us (21 CFR 807 Subpart C) Sample Pallection
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Fecal Occurt Blood Test
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In, Vitro Diagnostic Devices (OIVD)
Loughline Baututer
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Saf
510(k) K060930