(93 days)
The BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tubes and Kits are intended for the collection and transport of urine samples for culture and sensitivity testing of bacteria.
The BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tube is filled with lyophilized urine maintenance formula and evacuated to draw approximately 4 - 10 mL (depending on the tube size) of urine. The lyophilized urine maintenance formula can maintain the bacterial population in the urine specimen for a period of 48 hours at room temperature levels comparable to those urine specimens without additive, held under refrigeration for the same period of time.
The BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tube is a sterile, plastic, evacuated urine collection and transport tube for culture and sensitivity testing of bacteria. The benefits of a plastic tube decrease the occurrence of accidental breakage increases the safety of laboratory personnel and reduces the necessity of repeat specimens.
Acceptance Criteria and Study for BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tubes and Kits
This document describes the acceptance criteria and the study that demonstrates the BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tubes and Kits meet these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the device is its ability to maintain bacterial population in urine samples for 48 hours at room temperature, comparable to refrigerated samples without additive. The study's results are presented relative to this criterion.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain bacterial population in urine specimens for 48 hours at room temperature at levels comparable to those urine specimens without additive, held under refrigeration for the same period of time. | "The lyophilized urine maintenance formula can maintain the bacterial population in the urine specimen for a period of 48 hours at room temperature levels comparable to those urine specimens without additive, held under refrigeration for the same period of time." |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not explicitly state the specific number of samples used in the "extensive functional and clinical evaluations."
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It mentions "functional and clinical evaluations," implying a prospective approach, but no direct confirmation is provided.
3. Number and Qualifications of Experts for Ground Truth
- This assessment does not involve expert establishment of ground truth in the manner of diagnostic image interpretation. Instead, the ground truth relates to the bacterial population levels in the urine samples themselves, which would be determined through laboratory culture and quantification methods.
- The document does not specify the number or qualifications of experts involved in the laboratory testing or data analysis.
4. Adjudication Method for the Test Set
- As the study focuses on quantitative bacterial population maintenance rather than subjective interpretation, an adjudication method (like 2+1 or 3+1 for expert review) is not applicable or described. The results would be based on objective laboratory measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic collection and transport device, not a diagnostic imaging or interpretation tool where human readers assess cases. The study focuses on the device's ability to preserve specimens for laboratory analysis.
6. Standalone Performance Study
- Yes, a standalone study was performed. The "extensive functional and clinical evaluations" were conducted to assess the performance of the BD Vacutainer™ PLUS Plastic Urine C&S Preservative Tubes and kits themselves to determine their safety and efficacy. The comparison was against predicate devices and refrigerated non-additive samples, establishing the standalone performance of the new device in maintaining bacterial viability.
7. Type of Ground Truth Used
- The ground truth used was laboratory culture and quantification of bacterial populations in urine samples. This objective measurement determined whether the "bacterial population in the urine specimen" was maintained at comparable levels.
8. Sample Size for the Training Set
- This document does not describe a training set as would be relevant for machine learning algorithms. The study involves laboratory evaluations of a device, not the development or training of an AI model.
9. How Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set in the context of this device evaluation.
§ 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).