(344 days)
The Copan FecalSwab Collection, Transport and Preservation System is intended for collection of viable enteric pathogenic bacteria from rectal swabs and stool specimens during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimens are processed using standard clinical laboratory operating procedures for culture. Stool specimens collected with the Copan FecalSwab are also suitable for use with the BD MAX Enteric Bacterial Panel and the BD MAX Extended Enteric Bacterial Panel.
The FecalSwab Collection. Transport and Preservation System (Copan FecalSwab) is supplied in a collection kit format. Each collection kit consists of a package containing a plastic tube filled with 2 mL of FecalSwab transport and preservation medium and a specimen collection flocked swab intended both for rectal and stool specimen collection. In the laboratory, rectal and stool specimen are processed using standard clinical laboratory operating procedures for culture.
The FecalSwab transport and preservation medium is a maintenance medium comprised of: Chloride salts, Sodium salts, Phosphate buffer, L-Cysteine and Agar. The medium is designed to maintain the viability of enteric pathogenic bacteria during transit to the testing laboratory
The Copan FecalSwab Collection. Transport and Preservation System was previously cleared (K142094) for the collection of rectal swab and fecal specimens and to preserve the viability of enteric pathogenic bacteria during transport from the collection site to the testing laboratory. In the laboratory, FecalSwab specimen are intended be processed using standard clinical laboratory operating procedures for culture but is not cleared for use with downstream molecular assays. The FecalSwab has been demonstrated to be suitable for testing samples with the BD MAX Enteric Bacterial Panel (EBP) and BD MAX Extended Bacterial Panel (xEBP).
The provided document describes the acceptance criteria and supporting studies for the Copan FecalSwab Collection, Transport and Preservation System when used with the BD MAX Enteric Bacterial Panel (EBP) and BD MAX Extended Bacterial Panel (xEBP).
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Limit of Detection (LoD) | The FecalSwab collection device did not influence the LoD of the BD MAX EBP or BD MAX xEBP. The LoD is the concentration at which > 95% of the sample tested positive. | LoD values (CFU/mL) were identified for all tested organisms: Salmonella typhimurium (7.16E+05), Escherichia coli STX1 (1.30E+05), Campylobacter jejuni (1.17E+04), Shigella sonnei (1.74E+05), Plesiomonas shigelloides (7.94E+04), Yersinia enterocolitica (1.23E+05), Vibrio parahaemolyticus (7.12E+04), Escherichia coli ETEC (1.23E+05). These results "support that the FecalSwab has equivalent analytical performance to raw stool." |
| Bacterial Recovery (Viability) | For cultures from transport medium tubes held at both 2-8°C and 20-25°C, they must remain within 2 log10 of the initial microorganism concentration (time point 0). | For Plesiomonas shigelloides (ATCC 14029): |
- Swab Elution Method: At 2-8°C, log reduction at 72h was -0.17. At 20-25°C, log increase at 48h was 0.61.
- Roll Plate Method: At 2-8°C, log increase at 72h was 0.01. At 20-25°C, log increase at 48h was 0.92.
All data demonstrated the ability of the FecalSwab to maintain viability within the stated criteria. |
| Specimen Storage Stability | A minimum of 95% detection for all targets at 2-8ºC for up to 120 hours (5 days) or at 25±2ºC for up to 48 hours, when SBT was used as described in the study design. | Each organism tested for both BD MAX EBP and xEBP had ≥ 95% detection at all target storage stability time points claimed in the package insert. The lowest reported percentage positive was 96%. |
| PCR Interfering Substances | The Sample Processing Control (SPC) target should successfully amplify, indicating no interference or inhibition from the FecalSwab components. | Amplification of the SPC target was successful for 100% of replicates tested (e.g., 48/48 at Day 0, 24/24 at Day 1, etc.) across all stability time points. The results indicate that "there was no interference or inhibition in any of the component of the FecalSwab collection, transport, and preservation system." |
| Microbial Cross-Reactivity | No effect on the BD MAX EBP and BD MAX xEBP instruments or signal overlap when FecalSwab preserved stool specimens are used. (Implicitly, the device should not introduce new cross-reactivity not already accounted for by the BD MAX assays). | Data indicates that "the use of the FecalSwab to collect, transport and preserve stool specimens does not have any effect on the BD MAX EBP and BD MAX xEBP instruments or have any effect on signal overlap." No additional cross-reactivity studies were conducted as the assay design, reagents, workflow, algorithm, or interpretation of results for the BD MAX panels were unchanged. |
2. Sample sizes used for the test set and the data provenance
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Limit of Detection (LoD):
- Sample Size: For each organism and dilution, 150 µL of inoculated stool samples were used to spike 12 tubes of FecalSwab transport medium. From each FecalSwab tube, 50 µL were transferred into a total of 24 BD MAX sample buffer tubes (SBTs) in parallel. This procedure was repeated for each dilution and mix.
- Data Provenance: The study was conducted using a pooled negative clinical stool matrix, which was pre-tested with an FDA-cleared assay to confirm negativity for each target organism. Organisms used were ATCC strains (e.g., Salmonella typhimurium ATCC 14028). The country of origin for the clinical stool matrix is not specified, but the study implies a laboratory-based evaluation rather than field collection. This appears to be a prospective in-vitro study designed to establish analytical performance.
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Bacterial Recovery (Viability):
- Sample Size: Not explicitly stated as a distinct number of samples for the P. shigelloides study (which was the only new viability study). However, the tables show "Average CFU recovered from three lots," indicating at least three lots of FecalSwab were tested. Measurements were taken at T=0, 6h, 24h, 48h, and 72h.
- Data Provenance: Laboratory study using ATCC 14029 (Plesiomonas shigelloides). This is a prospective in-vitro study.
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Specimen Storage Stability:
- Sample Size: The study included four panels, each consisting of two different organisms mixed into clinical matrix and contrived at a concentration of 2 x LoD. For each time point and organism, the percentage positive was determined from replicates (e.g., 23/24, 24/24), implying 24 replicates per test condition.
- Data Provenance: Clinical matrix (stool) spiked with ATCC strains (e.g., Campylobacter jejuni ATCC 43429). The origin of the clinical matrix is not specified. This is a prospective in-vitro study.
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PCR Interfering Substances:
- Sample Size: The number of replicates tested ranged from 24 to 48, depending on the storage condition and time point (e.g., 48 replicates at Day 0, 24 replicates for most other time points).
- Data Provenance: The study assessed the FecalSwab components using spiked samples within the context of the Specimen Storage Stability studies. This is a prospective in-vitro study.
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Microbial Cross-Reactivity:
- Sample Size: No new studies were conducted.
- Data Provenance: Refers to previous studies for the original BD MAX EBP and BD MAX xEBP clearance. No specific details about those studies are provided here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts or their qualifications for establishing ground truth for the test sets. The studies described are analytical performance studies (LoD, viability, stability, interference) that rely on laboratory measurements (CFU/mL, % detection, SPC amplification) against predefined criteria, not expert interpretation of clinical data.
4. Adjudication method for the test set
Not applicable. The studies are analytical performance evaluations based on quantitative measurements or clear positive/negative detection, not subjective assessments requiring adjudication.
5. 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
Not applicable. This device is a pre-analytical collection and transport system for molecular diagnostic assays, not an AI-powered diagnostic imaging or interpretation device that would involve human readers or AI assistance in a clinical diagnostic workflow.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the Copan FecalSwab system itself, specifically its ability to preserve the viability of pathogens and not interfere with downstream molecular assays.
- Standalone aspects evaluated:
- Viability: Demonstrated the FecalSwab's ability to maintain bacterial viability over time and temperature (Tables 3 & 4).
- Non-interference/Compatibility: Demonstrated that the FecalSwab does not negatively influence the LoD of the BD MAX assays (Tables 1 & 2), does not interfere with PCR (Table 7), and ensures nucleic acid stability (Table 6).
The studies described are essentially "standalone" evaluations of the FecalSwab's analytical performance and compatibility with the BD MAX systems, as opposed to evaluating an AI algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these analytical studies was established through:
- Known concentrations of microorganisms: For LoD studies, organisms were serially diluted to known CFU/mL concentrations. For stability studies, samples were contrived at 2xLoD.
- Reference strains: ATCC strains were used (e.g., Salmonella typhimurium ATCC 14028, Plesiomonas shigelloides ATCC 14029).
- Pre-tested clinical matrix: Pooled negative clinical stool matrix was confirmed negative using an FDA-cleared assay before spiking with target organisms.
- Manufacturer's specifications/historical data: The LoD, stability, and cross-reactivity of the BD MAX EBP and xEBP panels themselves were previously established in their respective clearances. This submission evaluates the FecalSwab's compatibility with those established performance characteristics.
8. The sample size for the training set
Not applicable. This device is a physical collection and transport system, not an AI/ML algorithm that requires a "training set." The studies performed are analytical performance validations.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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).