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Found 3 results
510(k) Data Aggregation
(58 days)
The SAFETEX Chlamydia trachomatis Direct Specimen Collection Kit is utilized in situations where an in vitro diagnosis is warranted in obtaining cytology specimens for Chlamydial diagnostic testing.
Not Found
The provided text is a letter from the FDA regarding the K983599 submission for the "Safetex Chlamydia Trachomatis Specimen Collection Kit." It states that the device has been found substantially equivalent to predicate devices, but it does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information based solely on the provided text.
The document primarily focuses on regulatory approval and general controls provisions of the Medical Device Amendments. It does not include the detailed technical or clinical study data that would be necessary to answer your questions.
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(48 days)
The SAFETEX Cervical Spatula (plastic) is used to scrape and remove cytological material from the cervix or vagina.
Not Found
The document provided appears to be an FDA 510(k) clearance letter for a medical device: the SAFETEX Cervical Spatula (plastic). This letter indicates that the device has been found substantially equivalent to a predicate device already on the market. However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document is an administrative clearance letter and does not describe the technical details of the device's validation.
Therefore, I cannot fulfill the request to provide information about the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
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(101 days)
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