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Epitope Diagnostics CARE™ Fecal Occult Blood Test Device is a rapid immunological test intended for the qualitative detection of fecal occult blood in feces by professional laboratories and physician office laboratories. The test is intended for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer.

The CARE™ Fecal Occult Blood Test Device is recommended for use in (1) routine physical examinations, (2) monitoring any bleeding in patients, and (3) screening for colorectal cancer or gastrointestinal bleeding.

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The provided text is a 510(k) premarket notification approval letter for the CARE™ Fecal Occult Blood Test. However, it does not contain the acceptance criteria or a study description with the level of detail requested in the prompt.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not present the specific performance metrics (sensitivity, specificity, etc.) nor the details of any clinical or analytical study performed to prove this equivalence. The letter refers to "indications for use stated in the enclosure," but the enclosure provided focuses only on the "Indications for Use" statement and not the performance data.

Therefore, I cannot fully answer your request using only the provided text. I can, however, extract the information that is present:

Indications for Use (from the enclosure):
Epitope Diagnostics CARE™ Fecal Occult Blood Test Device is a rapid immunological test intended for the qualitative detection of fecal occult blood in feces by professional laboratories and physician office laboratories. The test is intended for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer.

The CARE™ Fecal Occult Blood Test Device is recommended for use in (1) routine physical examinations, (2) monitoring any bleeding in patients, and (3) screening for colorectal cancer or gastrointestinal bleeding.

The following information is NOT available in the provided document:

1. A table of acceptance criteria and the reported device performance: This information would typically be found in a summary of safety and effectiveness data, which is not part of this approval letter.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a rapid immunological test, not an AI-based imaging or diagnostic tool. Therefore, an MRMC study with human readers and AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable for this type of test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

To obtain the detailed information regarding acceptance criteria and study results, one would typically need to review the 510(k) summary document or the full 510(k) submission, which are usually publicly available on the FDA website for cleared devices.

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