(24 days)
The StatusFirst™ Strep A is intended for use as an in vitro diagnostic product for the qualitative detection of group A streptococcal antigen directly from throat swab specimens. The test is intended for use in the physician's offices, hospitals, and clinical laboratories as an aid in the clinical diagnosis of group A streptococcal infection.
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This document is a 510(k) clearance letter for three different Strep A rapid diagnostic tests: StatusFirst™ Strep A, BioStrep® A, and BioSign® Strep A / Status AccuStrepA™. However, it does not contain the detailed study information regarding acceptance criteria and performance data. The letter only states that the devices are substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information from this document. The document primarily focuses on the regulatory clearance for the device, not the technical performance study details.
§ 866.3740
Streptococcus spp. serological reagents.(a)
Identification. Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.