(147 days)
The Polymedco OC Auto Micro 80 Analyzer and OC Auto Micro FOB Test are designed to be used together as an immunological test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal (GI) disorders, e.g., colitis, polyps, and colorectal cancer.
The OC Auto Micro FOB Test is recommended for use in
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- Routine physical examinations
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- Monitoring for bleeding in patients
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- Screening for colorectal cancer or gastrointestinal bleeding
The Polymedco OC Auto Micro 80 Analyzer and OC Auto Micro FOB Test are designed to be used together as an immunological test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories.
This document is a 510(k) clearance letter for "The Polymedco OC Auto Micro 80 FOB Test." It describes the intended use of the device but does not contain information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information based on the provided text. The document confirms the device's substantial equivalence to a predicate device and states its indications for use, but it does not detail the technical performance data that would typically be included in a 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.