(88 days)
Teco Rapid Fecal Occult Blood (FOB) Card Test is an immunochromatographic assay intended for the determination of human hemoglobin in feces by professional laboratories or physicians offices. It is useful to determining gastrointestinal bleeding found in a number of gastrointestinal disorders such as colorectal carcinoma, colon polyps, diverticulitis and ulcerative colitis. Teco Rapid Fecal Occult Blood (FOB) Card Test is recommended for use in 1) routine physical examination 2) hospital monitoring for bleeding in patients, 3) screening for colorectal cancer or gastrointestinal bleeding from any source.
Teco Rapid Fecal Occult Blood (FOB) Card Test is an immunochromatographic assay.
The provided text is a 510(k) premarket notification letter from the FDA for the Teco Rapid Fecal Occult Blood (FOB) Card Test. It confirms substantial equivalence to a predicate device but does not contain the detailed study information required to answer the questions about acceptance criteria and device performance. The letter refers to an "enclosure" for the indications for use, and a subsequent page in the document does provide the indications for use, but still, no study details are present.
Therefore, I cannot provide the requested information from the given text. The document is primarily a regulatory approval letter, not a scientific study report.
§ 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.