(176 days)
The ImmoCARE® test is a rapid, immunochromatographic assay for the qualitative detection of intact hHB (human hemoglobin) in fecal specimens. It is a convenient and hygienic inethod for detecting human fecal occult blood, which may be indicative of gastrointestinal diseases associated with bleeding such as colorectal carcinoma, Crohn's disease, ulcerative colitis, and colon polyps in humans.
ImmoCARE® is an immunological test for both professional and over the counter use..
The ImmoCARE® test is a rapid, immunochromatographic assay for the qualitative detection of intact hHB (human hemoglobin) in fecal specimens.
This is a letter from the FDA to a medical device manufacturer, Care Diagnostic, Inc., regarding their ImmoCARE® device. It states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices. The letter does not contain information about acceptance criteria or performance studies. Therefore, I cannot provide the requested information.
§ 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.