(29 days)
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.
InSure® II fecal immunochemical test (FIT)
The provided text is a 510(k) premarket notification letter from the FDA to ENTERIX, Inc. for their InSure® II Fecal Immunochemical Test (FIT). It indicates that the device has been found substantially equivalent to a legally marketed predicate device.
However, the document does not contain any information about acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or details about ground truth establishment for either training or test sets.
Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.
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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
Page 1 (
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
§ 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.