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510(k) Data Aggregation
(54 days)
SCIMEDX CORP.
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(57 days)
SCIMEDX CORP.
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(53 days)
SCIMEDX CORP.
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(44 days)
SCIMEDX CORP.
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(35 days)
SCIMEDX CORP.
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(93 days)
SCIMEDX CORP.
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(92 days)
SCIMEDX CORP.
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(23 days)
SCIMEDX CORP.
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(53 days)
SCIMEDX CORP.
Eu-tTG®IgA assay is a qualitative ELISA test for the in vitro diagnostic detection of IgA antibody against the enzyme tissue Transglutaminase in human serum. This test is designed for use as an aid in the diagnosis of Celiac Disease.
Enzyme Immunoassay Kit
The provided text is a 510(k) clearance letter from the FDA for a device called "Eu-tTG® IgA Assay." This document is a regulatory communication, not a study report or clinical trial summary.
Therefore, it does not contain the information requested regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets and ground truth establishment.
The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices for the indicated use as "an aid in the diagnosis of Celiac Disease."
To obtain the requested information, one would need to consult the actual 510(k) submission document (K994379) itself, which would include the study data and performance claims.
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(30 days)
SCIMEDX CORP.
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