(112 days)
The Urine Monovette® boric acid is intended for use as a urine collection and transport device that maintains the integrity of the urine for delayed microbiological urine analysis
Urine Monovette® boric acid
The provided document is a 510(k) premarket notification letter from the FDA for the "Urine Monovette® boric acid" device. This document confirms the substantial equivalence of the device to a predicate device and allows it to be marketed.
However, the letter does not contain any information regarding acceptance criteria, study details, performance data, or ground truth establishment for the device's efficacy or performance.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."
Therefore, I cannot provide the requested information based on the content of this document. This letter is an approval for marketing based on substantial equivalence, not a detailed report of performance testing or clinical studies.
§ 866.2390 Transport culture medium.
(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).