(206 days)
Coproset Salmonella: In vitro Disposable diagnostic device with Selenite Broth intended for the collection and transport, from the collection site to the testing laboratory, of stool samples and for the enrichment of Salmonella spp.
Coproset Shigella: In vitro Disposable diagnostic device with GN Broth intended for the collection and transport from the collection site to the testing laboratory of stool samples and for the enrichment of Shigella spp
Uriset preservative tubes: Disposable in vitro diagnostic device for the collection and transport of urine samples from the collection site to the testing laboratory.
Swab set General Use: Disposable in vitro diagnostic device with Eugon Broth, intended for the collection and transport of pathogenic agents collected by swabs from the collection site to the testing laboratory and for enrichment of Streptococcus pyogenes, Staphylococcus aureus, Candida spp., Streptococcus agalactiae.
Coproset: disposable in vitro diagnostic device for the collection and transportation of stool samples and the enrichment of pathogenic organisms present in the sample.
Coproset Salmonella: In vitro Disposable diagnostic device with Selenite Broth intended for the collection and transport, from the collection site to the testing laboratory, of stool samples and for the enrichment of Salmonella spp.
Coproset Shigella: In vitro Disposable diagnostic device with GN Broth intended for the collection and transport from the collection site to the testing laboratory of stool samples and for the enrichment of Shigella spp.
Uriset Preservative tubes with holder: Disposable in vitro diagnostic device for the collection and transport of urine samples from the collection site to the testing laboratory.
Swab set General use: Disposable in vitro diagnostic device with Eugon Broth, intended for the collection and transport of pathogenic agents collected by swabs from the collection site to the testing laboratory and for enrichment of Streptococcus pyogenes, Staphylococcus aureus, Candida spp., Streptococcus agalactiae.
The provided text describes a 510(k) summary for several microbiological specimen collection and transport devices, namely Coproset Salmonella, Coproset Shigella, Uriset Preservative tubes, and Swab set General Use. The document details the device descriptions and general information but does not contain detailed information regarding acceptance criteria, specific study designs, or performance data in the format requested.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes for test/training sets, ground truth establishment, expert involvement, adjudication methods, or MRMC studies.
The document states: "Performance evaluation, further demonstrate the substantial equivalence and the safety and effectiveness of Diesse Devices when compared with the respective Predicate Device: in the case of Coproset devices and Swab set device viability of pathogen is maintained and the results obtained are comparable with those obtained for predicate device; Uriset preservative tubes with holder have the same intended use, Indication for use, material and design than its predicate device and thus it possible to conclude that they are substantially equivalent. The results obtained in the comparison between Uriset preservative tube and Vacutainer demonstrate that DIESSE Uriset give a good performance in terms of sample preservation and data are comparable with those obtained for the predicate device."
This statement indicates that performance evaluations were conducted, and the results were found to be "comparable" with predicate devices, suggesting the device does meet certain performance expectations. However, the specific metrics, criteria, and detailed study results demonstrating this comparison are not included in this summary.
In summary, the input text lacks the specific details required to answer your questions about acceptance criteria, study design, and performance metrics.
§ 866.2900 Microbiological specimen collection and transport device.
(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.