(40 days)
DakoCytomation Ltd IDEIA™ PCE Chlamydia is an immunoassay utilising dual amplification technology for the qualitative detection of Chlamydia lipopolysaccharide antigen in human urethral and endocervical swabs and male urines.
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This document is a 510(k) clearance letter from the FDA for the IDEIA™ PCE Chlamydia immunoassay. It does not contain the detailed study information regarding acceptance criteria or device performance that you are requesting.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which means it has been determined to be as safe and effective as a previously cleared device. However, it does not provide the specific performance data, acceptance criteria, or study details that would typically be found in a clinical study report or a more comprehensive submission document.
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§ 866.3120 Chlamydia serological reagents.
(a)
Identification. Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).(b)
Classification. Class I (general controls).