(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.
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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.
§ 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.