(71 days)
ColonCARE is a rapid, convenient, hygienic and highly sensitive (0.05 µg hHb/ml) method for the qualitative detection of occult blood in feces, which may be indicative of gastrointestinal diseases associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyp:
The test is recommended for use in the home or in medical facilities as a screening test for colorectal cance or gastrointestinal bleeding from any source.
Not Found
This document is a 510(k) clearance letter for the ColonCARE device, which means it does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.
The FDA 510(k) clearance process primarily ensures that a new device is "substantially equivalent" to a legally marketed predicate device. While this process involves review of data demonstrating safety and efficacy, the specific details of performance studies, acceptance criteria, ground truth establishment, expert qualifications, and AI-specific metrics (like MRMC studies) are not typically included or summarized in the clearance letter itself. These details would be found in the original 510(k) submission document submitted by the manufacturer.
Therefore, I cannot provide the requested information based solely on the provided text.
To answer your questions, I would need to access the full 510(k) submission for ColonCARE (K030216), which is generally not publicly available in its entirety. Some summaries are available, but they rarely include the fine-grained detail you're requesting.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 0 2 2003
Mr. Paul Swift Sales Manager Care Products, Inc. 231 Bank Street Waterbury. Connecticut 06702
Re: K030216
Trade/Device Name: ColonCARE Regulation Number: 21 CFR § 864.6550 Regulation Name: Occult Blood Test Regulatory Class: II Product Code: KHE Dated: March 10, 2003 Received: March 26, 2003
Dear Mr. Swift :
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.
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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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K030216 |
|---|---|
| Device Name: | ColonCARE |
Indications For Use:
ColonCARE is a rapid, convenient, hygienic and highly sensitive (0.05 µg hHb/ml) method for the qualitative detection of occult blood in feces, which may be indicative of gastrointestinal diseases associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyp:
The test is recommended for use in the home or in medical facilities as a screening test for colorectal cance or gastrointestinal bleeding from any source.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Josephine Bautista
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K030216
SIka9
§ 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.