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"OC-Sensor DIANA iFOB Test" is designed to be used together as an immunoassay test system. The test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal disorders (GI), e.g. colitis, polyps, and colorectal cancer. The OC-Sensor DIANA iFOB test is recommended for use in: 1. Routine physical examinations 2. Monitoring bleeding in patients 3. Screening for colorectal cancer or gastrointestinal bleeding

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The provided text is related to an FDA 510(k) clearance letter for the "OC-Sensor DIANA iFOB Test." It describes the intended use and regulatory classification of the device. However, it does not contain information about acceptance criteria, device performance, study details (like sample sizes, data provenance, expert qualifications, adjudication methods), or any comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the provided text.

The document mainly focuses on:

• Device Name: OC-Sensor DIANA iFOB Test
• Regulatory Information: 510(k) number K092330, Regulation Number 21 CFR 864.6550, Regulation Name Occult Blood Test, Regulatory Class Class II, Product Code OOX.
• Indications for Use: Qualitative detection of fecal occult blood in feces by professional laboratories for determining gastrointestinal bleeding (e.g., colitis, polyps, colorectal cancer), routine physical examinations, monitoring bleeding, and screening for colorectal cancer or GI bleeding.

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