(89 days)
The Greiner Vacuette Urine Count and Culture, Mannitol tube is a urine stabilization device intended for collection, transport and storage of urine for bacterial and yeast culture. Urine samples collected in the Greiner Vacuette Urine Count and Culture, Mannitol tube can be stored at 20-25°C for up to 48 h prior to culture. This device is intended for professional use only.
Vacuette Urine CCM tubes are tubes made of PET with a pre-defined vacuum to exact draw volumes. They are fitted with yellow Vacuette Safety Caps. The tube interior is sterile. The evacuated tube contains a fine particle granulate stabilizer to preserve the urine sample at 20-25°C for up to 48 hours. The stabilizer helps to preserve and protect the level of bacteria at collection and maintain typically formed elements in urine sediment.
The provided document describes the Greiner Vacuette Urine Count and Culture, Mannitol tube, a device intended for the collection, transport, and storage of urine for bacterial and yeast culture. The performance data section outlines the study conducted to demonstrate the device's suitability.
- A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Recovered organism count within +/- 1 log from the original spiked concentration. | Acceptable performance was demonstrated for all organisms tested. |
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Sample size used for the test set and the data provenance
- Sample size: All analyses were performed in triplicates (for each organism, at room temperature and refrigerated temperature). The organisms tested were 10 potential pathogens (Escherichia coli, Enterococcus faecalis, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus saprophyticus, Enterobacter cloacae, Klebsiella pneumoniae, Streptococcus agalactiae, Candida albicans, Candida glabrata). Therefore, the total number of samples processed for recovery testing was 10 organisms * 3 replicates * 2 temperature conditions = 60 samples.
- Data provenance: Not explicitly stated, but the study used ATCC cultures (American Type Culture Collection), which are standardized and universally recognized reference strains. The urine used was "sterile filtered urine." The study was conducted in accordance with CLSI M40-A2, a globally recognized standard.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study did not involve human interpretation or expert medical assessment for establishing ground truth. The study focused on the performance of the device in maintaining organism viability, which is a quantitative laboratory measurement.
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Adjudication method for the test set
This is not applicable, as the study does not involve expert review or interpretation of results that would require an adjudication method. The ground truth (original spiked concentration) is a predefined quantitative value.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a urine stabilization tube, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical product (a urine stabilization tube), not an algorithm or AI. The study evaluated the standalone performance of the device in maintaining microbial concentrations.
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The type of ground truth used
The ground truth was the original spiked concentration of ATCC cultures in sterile filtered urine. This is a form of controlled experimental data.
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The sample size for the training set
This is not applicable. The device is a physical product, not a machine learning model that requires a training set.
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How the ground truth for the training set was established
This is not applicable, as there is no training set for this type of device and study.
§ 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).