(79 days)
The IBD-SCAN™ test is a quantitative ELISA for measuring concentrations of fecal lactoferrin, a marker of fecal leukocytes. An elevated level is an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to distinguish messinal inflammatory bowel disease (IBD) from those with noninflammatory irritable bowel syndrome (IBS). FOR IN VITRO DIAGNOSTIC USE.
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The provided text is a 510(k) premarket notification letter from the FDA regarding the IBD-SCANTM device. It acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Therefore, I cannot provide the requested information based on the input text. The text only confirms the device's regulatory clearance and its intended use as an in vitro diagnostic aid for distinguishing inflammatory bowel disease (IBD) from irritable bowel syndrome (IBS) by measuring fecal lactoferrin.
§ 866.5570 Lactoferrin immunological test system.
(a)
Identification. A lactoferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the lactoferrin (an iron-binding protein with the ability to inhibit the growth of bacteria) in serum, breast milk, other body fluids, and tissues. Measurement of lactoferrin may aid in the diagnosis of an inherited deficiency of this protein.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.