(169 days)
dBest Urinary Tract Infection Test Kit for Home-Use is a simple one step urinalysis assay for rapid, semi-quantitative detection of the presence of Nitrite and Protein in human urine to aid in the diagnosis of urinary track infection. The dBest Urinary Tract Infection Kits are for home-use only.
dBest Urinary Tract Infection Test Kit for Home-Use is a simple one step urinalysis assay for rapid, semi-quantitative detection of the presence of Nitrite and Protein in human urine.
The provided document is a 510(k) clearance letter for the "dBest Urinary Track Infection Test Kit for Home-Use." It states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices. However, the document does not contain detailed information about acceptance criteria, specific device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested table and information based on the given text. The letter primarily focuses on regulatory approval and points to general controls provisions of the Act and other relevant FDA regulations.
To answer your request, I would need access to the actual 510(k) submission document or a summary of its contents, which would typically include the performance study details.
§ 862.1510 Nitrite (nonquantitative) test system.
(a)
Identification. A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.(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 § 862.9.