(74 days)
Copan UriSwab™ - Urine Collection, Transport and Preservation System is intended for the collection, transport and preservation of urine specimens from the collection site to the testing laboratory. UriSwab™ specimens are processed using standard clinical laboratory operating procedures for the cultivation of uropathogenic bacteria and yeasts.
Copan's UriSwab™ - Urine Collection, Transport and Preservation System (UriSwabTM) consists of screw cap self-standing tube with conical shaped bottom. Inside the tube, the cap holds a plastic stick with sponges made of hydrophilic polyurethane. The sponges incorporate preservative substances. Two types of collection systems are available: the regular size (100 mm length X 16 mm diameter) plastic tube and the mini size (80 mm length x 12 mm diameter) plastic tube.
This document describes the performance data for the Copan UriSwab™ - Urine Collection, Transport and Preservation System, focusing on its ability to maintain the viability of uropathogenic bacteria and yeasts in urine specimens for transport and preservation.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (CLSI M40-A2) | Reported Device Performance |
|---|---|
| Recovered organisms are within +/- 1 log from original spiked concentration | Viability and Recovery Testing: Demonstrated acceptable performance for all tested organisms (Candida albicans, Escherichia coli, Enterococcus faecalis, Pseudomonas aeruginosa, Proteus mirabilis, Staphylococcus saprophyticus, and other relevant urinary tract pathogens) at initial concentrations of 10^2, 10^3, and 10^4 CFU/ml when stored at room and refrigerated temperatures for up to 48 hours. |
| Organism Release Verification: Acceptable performance was achieved for Candida albicans, Escherichia coli, and Staphylococcus saprophyticus (at 10^2, 10^3, and 10^4 CFU/ml) when extracted by centrifugation and manual methods after 24 and 48 hours from UriSwab™ stored at room and refrigerated temperatures. | |
| Non-saturated Sponges: The ability to maintain initial concentration was verified for Escherichia coli, Pseudomonas aeruginosa, and Proteus mirabilis for up to 48 hours at room temperature, even with non-saturated sponges. |
Study Details:
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Sample Size and Data Provenance:
- Test Set Sample Size: Triplicate analyses were performed for each microorganism and initial concentration (10^2, 10^3, 10^4 CFU/ml) in the viability and recovery testing. This also applied to the organism release verification and non-saturated sponge studies, which involved specific microorganisms and three production lots. The exact total number of samples is not explicitly stated, but it involves multiple microorganisms, concentrations, storage conditions, and replicates.
- Data Provenance: The study used ATCC® cultures of potential urinary tract pathogens spiked into sterile synthetic urine. The origin of the synthetic urine is not specified. The study appears to be prospective as it involves controlled laboratory experiments.
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Number of Experts and Qualifications for Ground Truth:
- This study did not involve human interpretation of medical images or clinical data that would require experts to establish ground truth in the traditional sense of a diagnostic device. The ground truth was established by laboratory methods.
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Adjudication Method for the Test Set:
- Not applicable, as this was a laboratory study comparing quantitative microbiological recovery against a predefined acceptance criterion (+/- 1 log from original spiked concentration).
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not conducted as this is not an AI-based diagnostic imaging device requiring human-in-the-loop performance measurement.
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Standalone Performance Study:
- Yes, a standalone study was performed. The device's performance (UriSwab™) was evaluated independently against the CLSI M40-A2 standard for its ability to maintain microbial viability and allow for recovery.
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Type of Ground Truth Used:
- The ground truth was established through laboratory measurements of initial spiked concentrations of various microorganisms in sterile synthetic urine. The performance of the UriSwab™ was then compared to these initial concentrations.
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Sample Size for the Training Set:
- Not applicable. This device is a collection and transport system, not an algorithm that requires a training set. The microorganisms used for testing were ATCC® cultures.
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How Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this device.
§ 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).