(387 days)
The One Step Fecal Occult Blood (FOB) Test is a simple, direct binding immunoassay for the rapid and the qualitative detection of fecal occult blood by laboratories or physician's offices. It is useful to determine gastrointestinal bleeding found in gastrointestinal disorders. For professional in vitro diagnostic use only.
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The provided text does not contain information about the acceptance criteria, device performance, or any studies related to the IND One Step Fecal Occult Blood Test. The document is an FDA 510(k) clearance letter, which states that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the specific performance studies, acceptance criteria, or their results.
Therefore, I cannot provide the requested information based on the input text.
§ 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.