(81 days)
ColoScreen-ES is designed for the qualitative detection of fecal occult blood. It is an aid in the diagnosis of gastrointestinal disorders such as hemorrhoids, diverticulitis, fissures, colitis or colorectal cancer. The test can be used in mass health screens, doctors offices or hospitals.
Not Found
The provided text describes the FDA's 510(k) clearance for the ColoScreen-ES device, a qualitative test for fecal occult blood. However, it does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.
The document is a clearance letter, indicating that the device has been deemed substantially equivalent to a predicate device. It briefly mentions the intended use of the ColoScreen-ES as an aid in diagnosing gastrointestinal disorders and for mass health screens, doctor's offices, or hospitals.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for the test set
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance study results
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
§ 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.