(194 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 is a 510(k) clearance letter from the FDA for the "IND One Step Fecal Occult Blood Test." It primarily states that the device has been found substantially equivalent to a legally marketed predicate device.
Unfortunately, this document does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria, study design, reported device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.
This type of information is typically found in the 510(k) submission itself, or in supplementary documents such as clinical study reports or performance verification reports, which are not included in this letter.
Therefore, I cannot provide the requested table and details based solely on the provided text. The document confirms the device's clearance but does not elaborate on the specific performance data or study methodology used to achieve that clearance.
§ 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.