(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
-
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.
-
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.
-
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.
-
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.
-
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 16, 2022
Copan Italia S.p.A. Elisabetta Zanella Chief Regulatory Officer via F. Perotti 10 Brescia, 25125 Italy
Re: K220052
Trade/Device Name: Copan FecalSwab Collection, Transport and Preservation System Regulation Number: 21 CFR 866.2390 Regulation Name: Transport culture medium Regulatory Class: Class I, reserved Product Code: JSM Dated: December 31, 2021 Received: January 6, 2022
Dear Elisabetta Zanella:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
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- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220052
Device Name
Copan FecalSwab Collection, Transport and Preservation System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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510K SUMMARY
Copan FecalSwab Collection, Transport and Preservation System Migration to BD MAX Enteric Bacterial Panel (EBP) & BD MAX Extended Bacterial Panel (xEBP)
1. General Information
| Applicant/Sponsor: | COPAN ITALIASpA Via F. Perotti10 25125 Brescia, ItalyTel. +39 030 2687212 |
|---|---|
| Contact Person(s): | Ms. Vanessa BonomiMs. Elisabetta ZanellaTel. +39 030 2687212Email: regulatory.affairs@copangroup.com |
Summary Prepared Date: 31st December 2021
2. Device
| Trade Name: | Copan FecalSwab Collection, Transport and PreservationSystem |
|---|---|
| Common Name: | Collection and Transport Device |
| Classification Name: | Culture Media, Non-Propagating Transport |
| Classification Panel: | Microbiology |
| Classification Regulation: | 21 CFR 866.2390 |
| Product Code: | JSM, LIO |
| Class: | Class I |
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3. Predicate Device
Predicate device name (s):
Copan FecalSwab Collection, Transport and Preservation System - K142094
4. Device Description
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).
5. Indications for use
The Copan FecalSwab Collection, Transport and Preservation System is intended for collection and preservation 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.
Special conditions for use statement(s): For prescription use only
Special Instrument Requirements:
The BD MAX Enteric Bacterial Panel and BD MAX Extended Enteric Bacterial Panel are for use on the BD MAX System.
6. Comparison with predicate
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The Copan FecalSwab System is substantially equivalent to the predicate specimen collection and transport device. The Copan Fecal Swab System and the predicate device are similar in intended use and overall function.
Comparison table:
| Device & PredicateDevice(s): | Device: K220052 | Predicate: K142094 |
|---|---|---|
| Device Trade Name | Copan FecalSwab Collection,Transport and PreservationSystem | Copan FecalSwabCollection, Transport andPreservation System |
| General DeviceCharacteristic | Copan FecalSwab is aCollection, Transport andPreservation System suppliedin a collection kit format. | Copan FecalSwab is aCollection, Transport andPreservation Systemsupplied in a collection kitformat. |
| General Device Characteristic Similarities | ||
| Intended Use;Collection Device | The Copan FecalSwabCollection, Transport andPreservation System is intendedfor collection and preservationof viable enteric pathogenicbacteria from rectal swabs andstool specimens duringtransport from the collectionsite to the testing laboratory forstandard culture procedures.Stool specimens collected withthe Copan FecalSwab are alsosuitable for use with the BDMAX Enteric Bacterial Paneland the BD MAX ExtendedBacterial Panel. | The Copan FecalSwabCollection, Transport andPreservation System isintended for the collectionof rectal swab and fecalspecimens and to preservethe viability of entericpathogenic bacteria duringtransport from the collectionsite to the testing laboratory.In the laboratory, FecalSwabspecimens are processedusing standard clinicallaboratory operatingprocedures for culture. |
| Specimen Type | Stool specimen, rectalspecimenNote: The scope of thisclearance does not intend toseek claims for use of rectalspecimens with the BD MAXEBP and xEBP Assays. | Same |
| Microorganismssupported | Enteric pathogenic bacteria | Same |
| Single Use Device | Yes | Same |
| Container | Polypropylene conical bottomvial | Same |
| ProductConfiguration | Medium in vial & cap Systemincluding Medium and swab inpeel pouch option. | Same |
| pH of Medium | 6.90 - 7.50 | Same |
| Storage Temperature | 5-25°C | Same |
| Medium Volume | 2 mL | Same |
| Swab Shaft | Plastic | Same |
| Swab Tip | Flocked nylon | Same |
| Shelf Life | 15 months | Same |
| Medium Formulation | Chloride saltsSodium saltsPhosphate bufferL-CysteineAgarDistilled water | Same |
| Product code | JSM, LIO | Same |
| General Device Characteristic Differences | ||
| Claimed instrumentplatforms | The BD MAX Enteric BacterialPanel and the BD MAXExtended Enteric BacterialPanel. | None |
| List of claimedorganisms | Escherichia coliEscherichia coli O157:H7Salmonella typhimuriumShigella sonneiCampylobacter jejuniYersinia enterocoliticaVibrio parahaemolyticusEnterococcus faecalisVancomycin resistant (VRE)Clostridium difficilePlesiomonas shigelloides | Escherichia coliEscherichia coli O157:H7Salmonella typhimuriumShigella sonneiCampylobacter jejuniYersinia enterocoliticaVibrio parahaemolyticusEnterococcus faecalisVancomycin resistant (VRE)Clostridium difficile |
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7. Summary of Performance Testing
Studies were conducted to evaluate the performance characteristics of the Copan FecalSwab System components as well as the complete FecalSwab collection kit formats.
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Detection Limit
The LoD study using the Copan FecalSwab indicated that the FecalSwab Collection device did not influence the LoD of the BD MAX Enteric Bacterial Panel or BD MAX Extended Enteric Bacterial Panel. The pooled negative clinical stool matrix was pre-tested with an FDA cleared assay for each target organism and determined to be negative prior to use. The stool matrix was used as a negative sample or was spiked to generate positive samples with the following organisms: Salmonella typhimurium, ATCC 14028; Escherichia coli STX1, ATCC 43890; Campylobacter jejuni, ATCC 43429 and Shigella sonnei, ATCC 9290. A 0.5 McFarland standard was made for each organism and further diluted. The 0.5 McFarland was confirmed with culture to determine the CFU/mL concentration, each organism was then serially diluted down to the LoD. The LoD is reported in CFU/mL.
150 µL each of the inoculated stool samples was used to spike 12 tubes of the FecalSwab transport medium according to the IFU. After inoculation. 50 uL of each inoculated FecalSwab tube specimens were transferred into a total of 24 BD MAX sample buffer tubes (SBTs) in parallel according to the manufacturer's instructions for BD MAX assays. This procedure was repeated for each dilution and mix. The external controls were processed and tested as described in the BD MAX EBP and BD MAX xEBP IFUs. The LoD is the concentration at which > 95% of the sample tested positive. Table 1 and 2 include the LoD concentrations of organisms in CFU/mL when FecalSwab specimens were tested with the BD MAX EBP and BD MAX xEBP.
| Table 1: Limit of Detection Concentrations (CFU/mL) for FecalSwab specimens tested with |
|---|
| BD MAX Enteric Bacterial Panel |
| Specimentype | SalmonellatyphimuriumATCC 14028 | Escherichia coliSTX1ATCC 43890 | CampylobacterjejuniATCC 43429 | Shigella sonneiATCC 9290 |
|---|---|---|---|---|
| FecalSwab | 7.16E+05 | 1.30E+05 | 1.17E+04 | 1.74E+05 |
Table 2: Limit of Detection Concentrations (CFU/mL) for FecalSwab specimens tested with BD MAX Extended Enteric Bacterial Panel
| Specimen type | Plesiomonas shigelloidesATCC 14029 | Yersinia enterocoliticaATCC 9610 | Vibrio parahaemolyticusATCC 17802 | Escherichia coliETECATCC 35401 |
|---|---|---|---|---|
| FecalSwab | 7.94E+04 | 1.23E+05 | 7.12E+04 | 1.23E+05 |
For each organism tested across both the BD MAX enteric bacterial panel and extended bacterial panel, an LoD was identified. These results support that the FecalSwab has equivalent analytical performance to raw stool when used with BD MAX EBP and BD MAX xEBP cleared devices.
Bacterial Recovery (Viability)
Bacterial Recovery (Viability) Studies in the original clearance for the Copan fecal swab (K142094) did not include Plesiomonas shigelloides (P. shigelloides) (ATCC 14029) as a claimed organism. P. shigelloides is a claimed organism on the BD MAX EBP and xEBP panel and as a result P. shigelloides is added to the claimed organisms for the subject
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device. All other organisms claimed on the BD MAX EBP and xEBP panel have been previously validated with viability studies using the subject device (K142094). Recovery studies for P. shigelloides to evaluate viability using the FecalSwab to maintain viability were performed using the roll plate method and the swab elution method. The acceptance criteria for both methods were that, 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). All data demonstrated the ability of the FecalSwab to maintain viability of bacteria under the claimed conditions of use (table 3 and 4).
Table 3: Summary of Plesiomonas shigelloides Recovery Study (Swab Elution Method)
| Average CFU recovered from three lots | ||||||
|---|---|---|---|---|---|---|
| HoldingTemperature | T=0 | T=6h | T=24h | T=48h | T=72h | T=48/72hrs. Logreduction(-)or Logincrease(+) |
| 2-8°C | 1.19E+03 | 1.17E+03 | 1.02E+03 | 9.26E+02 | 8.01E+02 | -0.17 |
| 20-25°C | 1.19E+03 | 1.09E+03 | 2.23E+03 | 4.95E+03 | 0.61 |
| Table 4: Summary of Plesiomonas shigelloides Recovery Study (Roll Plate Method) | |||
|---|---|---|---|
| --------------------------------------------------------------------------------- | -- | -- | -- |
| Average CFU recovered from three lots | ||||||
|---|---|---|---|---|---|---|
| HoldingTemperature | T=0 | T=6h | T=24h | T=48h | T=72h | T=48/72 hrs.Log reduction(-)or Log increase(+) |
| 2-8°C | 1.31E+02 | 1.11E+02 | 1.12E+02 | 1.17E+02 | 1.35E+02 | 0.01 |
| 20-25°C | 1.31E+02 | 1.21E+02 | 1.83E+02 | 1.09E+03 | 0.92 |
Specimen Storage Stability
Nucleic acid storage and stability was evaluated for specimens stored in the FecalSwab collection device under the same storage conditions claimed in BD MAX EBP and BD MAX xEBP clearance when using preserved stool specimens. The original clearance for BD MAX EBP and BD MAX xEBP was 25 ± 2℃ for 24 hrs or 2-8℃ for 5 days prior to testing. A study was conducted to test the previously cleared stability claims of 25 ± 2℃ for 24 hrs or 2-8°C for 5 days, using the subject transport device. Studies included a nested stability testing to show that specimens stored in FecalSwab medium at the described conditions (i.e., Day 1: 24 hours in FecalSwab at 25±2°C, Day 3: 24 hours in FecalSwab at 25±2°C + 48 hours at 25±2ºC in SBT, Day 6: 24 hours in FecalSwab at 25±2ºC+ 5 days at 2-8ºC in SBT, Day 5: 5
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days in FecalSwab at 2-8°C, Day 7: 5 days in FecalSwab at 2-8°C + 48 hours at 25±2°C in SBT, and Day 10: 5 days in FecalSwab at 2-8°C + 5 days at 2-8°C in SBT) continued to be stable at 2-8ºC for up to 120 hours (5 days) or at 25 ± 2ºC for up to 48 hours. The study included four panels consisting of two different organisms mixed into each panel. Each panel used clinical matrix and was contrived at a concentration of 2 x LoD (Table 5). The acceptance criteria for the Fecalswab were 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 above in parentheses and results showed that each organism tested for both BD MAX EBP and xEBP had ≥ 95% detection at all the target storage stability time points claimed in the package insert (as shown in Table 6).
| Table 5: Specimen Stability Multiplex Organism Mix Compositions and Organisms |
|---|
| Concentration in SBT during the test Expressed in Colony Forming |
| Units (CFU/mL). |
| PANEL | ORGANISMS | CFUs/mL inSBT (LoD)from the PI | CFUs/mL inSBT (2XLoD)from the PI | Actual 2XLoDconcentration of eachstrain in CFUs/mLSBT |
|---|---|---|---|---|
| BD MAX EBPmultiplex mix #1 | Campylobacter jejuni | 10 | 20 | 56 |
| BD MAX EBPmultiplex mix #1 | Shigella sonnei | 124 | 248 | 144 |
| BD MAX EBPmultiplex mix #2 | Escherichia coli STX1 | 223 | 446 | 361 |
| BD MAX EBPmultiplex mix #2 | Salmonella typhimurium | 193 | 386 | 373 |
| BD MAX xEBPmultiplex mix #1 | Yersinia enterocolitica | 227 | 454 | 576 |
| BD MAX xEBPmultiplex mix #1 | Escherichia coli ETEC | 137 | 274 | 361 |
| BD MAX xEBPmultiplex mix #2 | Vibrio parahaemolyticus | 124 | 248 | 396 |
| BD MAX xEBPmultiplex mix #2 | Plesiomonas shigelloides | 257 | 514 | 329 |
Table 6: Summary of FecalSwab specimen storage stability results with BD MAX EBP and BD MAX xEBP
| FecalSwab 25±2°C nested to SBT at 2-8°C and 25±2°C | FecalSwab 2-8°C nested to SBT at 2-8°C and 25±2°C | |||||
|---|---|---|---|---|---|---|
| Organism | Day | N° positive replicates | % Pos | Day | N° positive replicates | % Pos |
| Plesiomonas shigelloidesATCC 14029 | 1 | 23/24 | 96 | 5 | 24/24 | 100 |
| 3 | 24/24 | 100 | 7 | 24/24 | 100 | |
| 6 | 24/24 | 100 | 10 | 24/24 | 100 | |
| Vibrio parahaemolyticusATCC 17802 | 1 | 24/24 | 100 | 5 | 24/24 | 100 |
| 3 | 24/24 | 100 | 7 | 24/24 | 100 | |
| 6 | 24/24 | 100 | 10 | 24/24 | 100 | |
| Yersinia enterocolitica | 1 | 24/24 | 100 | 5 | 24/24 | 100 |
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Copan FecalSwab™ Collection, Transport and Preservation System Copan Italia S.p.A Traditional 510(K) Premarket Notification
| Traditional 510(K) Premarket Notification | December 2021 | |||||
|---|---|---|---|---|---|---|
| ATCC 9610 | 3 | 24/24 | 100 | 7 | 24/24 | 100 |
| 6 | 24/24 | 100 | 10 | 24/24 | 100 | |
| Escherichia coli ETEC | 1 | 24/24 | 100 | 5 | 24/24 | 100 |
| ATCC 35401 | 3 | 24/24 | 100 | 7 | 24/24 | 100 |
| 6 | 24/24 | 100 | 10 | 24/24 | 100 | |
| 1 | 24/24 | 100 | 5 | 24/24 | 100 | |
| Campylobacter jejuni | 3 | 24/24 | 100 | 7 | 24/24 | 100 |
| ATCC 43429 | 6 | 23/24 | 96 | 10 | 24/24 | 100 |
| 1 | 24/24 | 100 | 5 | 24/24 | 100 | |
| Shigella sonnei | 3 | 24/24 | 100 | 7 | 24/24 | 100 |
| ATCC 9290 | 6 | 24/24 | 100 | 10 | 24/24 | 100 |
| Escherichia coli STX1 | 1 | 24/24 | 100 | 5 | 24/24 | 100 |
| ATCC 43890 | 3 | 24/24 | 100 | 7 | 24/24 | 100 |
| 6 | 24/24 | 100 | 10 | 24/24 | 100 | |
| Salmonella typhimurium | 1 | 24/24 | 100 | 5 | 24/24 | 100 |
| ATCC 14028 | 3 | 24/24 | 100 | 7 | 24/24 | 100 |
| 6 | 24/24 | 100 | 10 | 24/24 | 100 |
PCR Interfering Substances
Exogenous interfering substance studies were conducted in the original BD MAX EBP and BD MAX xEBP clearance. An additional interference study was conducted to assess the contents of the Copan FecalSwab Collection, Transport and Preservation System using the sample processing control (SPC) that is included with BD MAX EBP and BD MAX xEBP assays. The SPC target is intended to monitor the presence of potential inhibitory substances in each reaction. In this case, the swabs were left inside the transport device tubes for the duration of the incubation period and amplification of the sample processing control (SPC) target was successful at every stability time point tested. The results indicate that there was no interference or inhibition in any of the component of the FecalSwab collection, transport, and preservation system. The SPC monitors DNA extraction, thermal cycling, reagent integrity and the presence of inhibitory substances. Results of tests are shown in table 7.
- Table 7: PCR Interfering Substance SPC Results from FecalSwab Specimen Storage Stability Studies.
| Specimenstoragecondition inFecalSwab | Specimenstoragecondition inSBT | TotalDays | Numberofreplicatestested | Number ofreplicatesprovidingamplification forSPC target |
|---|---|---|---|---|
| NA | NA | 0 | 48 | 48/48 |
| 1 Day at 25±2°C | NA | 1 | 24 | 24/24 |
| 2 Days at 25±2°C | NA | 2 | 24 | 24/24 |
{11}------------------------------------------------
Copan FecalSwab™ Collection, Transport and Preservation System Copan Italia S.p.A Traditional 510(K) Premarket Notification
| December 2021 | |
|---|---|
| --------------- | -- |
| 1 Day at 25±2°C | 2 Days at 25±2°C | 3 | 24 | 24/24 |
|---|---|---|---|---|
| 1 Day at 25±2°C | 3 Days at 25±2°C | 4 | 24 | 24/24 |
| 1 Day at 25±2°C | 5 Days at 2-8°C | 6 | 24 | 24/24 |
| 1 Day at 25±2°C | 6 Days at 2-8°C | 7 | 24 | 24/24 |
| 5 Days at 2-8°C | NA | 5 | 24 | 24/24 |
| 6 Days at 2-8°C | NA | 6 | 24 | 24/24 |
| 5 Days at 2-8°C | 2 Days at 25±2°C | 7 | 24 | 24/24 |
| 5 Days at 2-8°C | 3 Days at 25±2°C | 8 | 24 | 24/24 |
| 5 Days at 2-8°C | 5 Days at 2-8°C | 10 | 24 | 24/24 |
| 5 Days at 2-8°C | 6 Days at 2-8°C | 11 | 24 | 24/24 |
Microbial cross-reactivity
Microbial cross-reactivity studies were conducted in the original BD MAX EBP and BD MAX xEBP clearance. No modifications were made to the BD MAX EBP and BD MAX xEBP assay design, reagents, workflow, algorithm, or interpretation of results when the FecalSwab preserved stool specimens are used in combination with BD MAX EBP and BD MAX xEBP. 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. As a result, not additional cross reactivity studies were conducted.
8. Summary of Clinical Testing as Basis for Substantial Equivalence
No clinical testing was conducted to support this submission
9. Conclusions Drawn from Non-Clinical Tests
The similarities in the intended use, operational characteristics, and functional technological characteristics between the Copan FecalSwab system and the predicate led to a conclusion of substantial equivalence between the Copan FecalSwab and predicate 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).