(344 days)
No
The summary describes a collection and transport system for biological samples and does not mention any computational analysis or algorithms.
No
Explanation: This device is for collecting, transporting, and preserving viable enteric pathogenic bacteria from rectal swabs and stool specimens, not for treating any condition or disease. It is a collection and transport system for diagnostic purposes.
No
Explanation: This device is a collection, transport, and preservation system for specimens, not a diagnostic device itself. It is used to prepare samples for diagnostic testing (culture or molecular assays).
No
The device is a collection, transport, and preservation system consisting of a plastic tube, transport medium, and a flocked swab, which are all physical components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is for the "collection of viable enteric pathogenic bacteria from rectal swabs and stool specimens during transport from the collection site to the testing laboratory." It also mentions that the specimens are "processed using standard clinical laboratory operating procedures for culture" and are "suitable for use with the BD MAX Enteric Bacterial Panel and the BD MAX Extended Enteric Bacterial Panel." These are all activities performed in a clinical laboratory setting for diagnostic purposes.
- Device Description: The description details a "collection kit format" with a tube of "transport and preservation medium" and a "specimen collection flocked swab." This is a system designed to collect and preserve biological specimens for subsequent laboratory testing.
- Performance Studies: The document describes various performance studies, including "Detection Limit," "Bacterial Recovery (Viability)," "Specimen Storage Stability," "PCR Interfering Substances," and "Microbial cross-reactivity." These types of studies are conducted to validate the performance of a device used in diagnostic testing.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K142094) indicates that this device is being compared to a previously cleared device, which is a common process for IVDs seeking regulatory clearance.
The entire context of the document points to a device designed to collect and transport biological samples for in vitro diagnostic testing in a clinical laboratory.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JSM, LIO
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 Enteric Bacterial Panel (xEBP).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rectal, Stool
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Detection Limit Study:
- Study Type: Analytical study to determine the Limit of Detection (LoD).
- Sample Size: For each organism and dilution, 12 tubes of FecalSwab transport medium were spiked, and then 50 uL of each inoculated FecalSwab tube was transferred to 24 BD MAX sample buffer tubes.
- Key Results:
- The FecalSwab Collection device did not influence the LoD of the BD MAX Enteric Bacterial Panel or BD MAX Extended Enteric Bacterial Panel.
- LoDs were identified for each organism tested across both BD MAX enteric bacterial panel and extended bacterial panel, demonstrating equivalent analytical performance to raw stool when used with BD MAX EBP and BD MAX xEBP cleared devices.
- Table 1 (BD MAX Enteric Bacterial Panel LoDs in CFU/mL):
- Salmonella typhimurium ATCC 14028: 7.16E+05
- Escherichia coli STX1 ATCC 43890: 1.30E+05
- Campylobacter jejuni ATCC 43429: 1.17E+04
- Shigella sonnei ATCC 9290: 1.74E+05
- Table 2 (BD MAX Extended Enteric Bacterial Panel LoDs in CFU/mL):
- Plesiomonas shigelloides ATCC 14029: 7.94E+04
- Yersinia enterocolitica ATCC 9610: 1.23E+05
- Vibrio parahaemolyticus ATCC 17802: 7.12E+04
- Escherichia coli ETEC ATCC 35401: 1.23E+05
Bacterial Recovery (Viability) Study:
- Study Type: Viability studies for Plesiomonas shigelloides (P. shigelloides) using the roll plate method and the swab elution method.
- Sample Size: Not explicitly stated for P. shigelloides, but results are averaged from three lots.
- Key Results:
- 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 (Summary of Plesiomonas shigelloides Recovery Study - Swab Elution Method):
- 2-8°C holding: Log reduction/increase at 48/72 hrs. was -0.17.
- 20-25°C holding: Log reduction/increase at 48/72 hrs. was 0.61.
- Table 4 (Summary of Plesiomonas shigelloides Recovery Study - Roll Plate Method):
- 2-8°C holding: Log reduction/increase at 48/72 hrs. was 0.01.
- 20-25°C holding: Log reduction/increase at 48/72 hrs. was 0.92.
Specimen Storage Stability Study:
- Study Type: Evaluation of nucleic acid storage and stability for specimens stored in the FecalSwab collection device.
- Sample Size: Not explicitly stated for total samples, but results are reported as N° positive replicates out of 24.
- Key Results:
- 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.
- Results showed that each organism tested for both BD MAX EBP and xEBP had ≥ 95% detection at all targeted storage stability time points claimed in the package insert.
- Examples from Table 6 (Summary of FecalSwab specimen storage stability results with BD MAX EBP and BD MAX xEBP):
- Plesiomonas shigelloides ATCC 14029: 96-100% positive replicates across various time points and temperatures.
- Vibrio parahaemolyticus ATCC 17802: 100% positive replicates across various time points and temperatures.
- Yersinia enterocolitica ATCC 9610: 100% positive replicates across various time points and temperatures.
- Escherichia coli ETEC ATCC 35401: 100% positive replicates across various time points and temperatures.
- Campylobacter jejuni ATCC 43429: 96-100% positive replicates across various time points and temperatures.
- Shigella sonnei ATCC 9290: 100% positive replicates across various time points and temperatures.
- Escherichia coli STX1 ATCC 43890: 100% positive replicates across various time points and temperatures.
- Salmonella typhimurium ATCC 14028: 100% positive replicates across various time points and temperatures.
PCR Interfering Substances Study:
- Study Type: Interference study to assess the contents of the Copan FecalSwab Collection, Transport and Preservation System using the sample processing control (SPC).
- Sample Size: 24 or 48 replicates for each condition.
- Key Results:
- 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.
- Table 7 (PCR Interfering Substance SPC Results from FecalSwab Specimen Storage Stability Studies): All tested conditions (various days and temperatures in FecalSwab and SBT) showed 100% (24/24 or 48/48) replicates providing amplification for SPC target.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Detection Limit: LoD (CFU/mL) values are provided.
- Bacterial Recovery (Viability): Log reduction/increase compared to initial concentration.
- Specimen Storage Stability: Percentage of positive replicates (≥95% acceptance criteria).
- PCR Interfering Substances: Number of replicates providing amplification for SPC target (percentage of successful amplification).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
1
- 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
2
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 ITALIA
SpA Via F. Perotti
10 25125 Brescia, Italy
Tel. +39 030 2687212 |
|--------------------|----------------------------------------------------------------------------------------------------------------------|
| Contact Person(s): | Ms. Vanessa Bonomi
Ms. Elisabetta Zanella
Tel. +39 030 2687212
Email: regulatory.affairs@copangroup.com |
Summary Prepared Date: 31st December 2021
2. Device
| Trade Name: | Copan FecalSwab Collection, Transport and Preservation
System |
|----------------------------|------------------------------------------------------------------|
| 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 |
4
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
5
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 & Predicate
| Device(s): | Device: K220052 | Predicate: K142094 |
|---|---|---|
| Device Trade Name | Copan FecalSwab Collection, | |
| Transport and Preservation | ||
| System | Copan FecalSwab | |
| Collection, Transport and | ||
| Preservation System | ||
| General Device | ||
| Characteristic | Copan FecalSwab is a | |
| Collection, Transport and | ||
| Preservation System supplied | ||
| in a collection kit format. | Copan FecalSwab is a | |
| Collection, Transport and | ||
| Preservation System | ||
| supplied in a collection kit | ||
| format. | ||
| General Device Characteristic Similarities | ||
| Intended Use; | ||
| Collection Device | 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 for | ||
| standard culture procedures. | ||
| Stool specimens collected with | ||
| the Copan FecalSwab are also | ||
| suitable for use with the BD | ||
| MAX Enteric Bacterial Panel | ||
| and the BD MAX Extended | ||
| Bacterial Panel. | The Copan FecalSwab | |
| Collection, Transport and | ||
| Preservation System is | ||
| intended 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 | ||
| specimens are processed | ||
| using standard clinical | ||
| laboratory operating | ||
| procedures for culture. | ||
| Specimen Type | Stool specimen, rectal | |
| specimen | ||
| Note: The scope of this | ||
| clearance does not intend to | ||
| seek claims for use of rectal | ||
| specimens with the BD MAX | ||
| EBP and xEBP Assays. | Same | |
| Microorganisms | ||
| supported | Enteric pathogenic bacteria | Same |
| Single Use Device | Yes | Same |
| Container | Polypropylene conical bottom | |
| vial | Same | |
| Product | ||
| Configuration | Medium in vial & cap System | |
| including Medium and swab in | ||
| peel 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 salts | |
| Sodium salts | ||
| Phosphate buffer | ||
| L-Cysteine | ||
| Agar | ||
| Distilled water | Same | |
| Product code | JSM, LIO | Same |
| General Device Characteristic Differences | ||
| Claimed instrument | ||
| platforms | The BD MAX Enteric Bacterial | |
| Panel and the BD MAX | ||
| Extended Enteric Bacterial | ||
| Panel. | None | |
| List of claimed | ||
| organisms | Escherichia coli | |
| Escherichia coli O157:H7 | ||
| Salmonella typhimurium | ||
| Shigella sonnei | ||
| Campylobacter jejuni | ||
| Yersinia enterocolitica | ||
| Vibrio parahaemolyticus | ||
| Enterococcus faecalis | ||
| Vancomycin resistant (VRE) | ||
| Clostridium difficile | ||
| Plesiomonas shigelloides | Escherichia coli | |
| Escherichia coli O157:H7 | ||
| Salmonella typhimurium | ||
| Shigella sonnei | ||
| Campylobacter jejuni | ||
| Yersinia enterocolitica | ||
| Vibrio parahaemolyticus | ||
| Enterococcus faecalis | ||
| Vancomycin 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 |
| Specimen
type | Salmonella
typhimurium
ATCC 14028 | Escherichia coli
STX1
ATCC 43890 | Campylobacter
jejuni
ATCC 43429 | Shigella sonnei
ATCC 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 shigelloides
ATCC 14029 | Yersinia enterocolitica
ATCC 9610 | Vibrio parahaemolyticus
ATCC 17802 | Escherichia coli
ETEC
ATCC 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
8
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 | ||||||
|---|---|---|---|---|---|---|
| Holding | ||||||
| Temperature | T=0 | T=6h | T=24h | T=48h | T=72h | T=48/72 |
| hrs. Log | ||||||
| reduction | ||||||
| (-) | ||||||
| or Log | ||||||
| increase | ||||||
| (+) | ||||||
| 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 | ||||||
|---|---|---|---|---|---|---|
| Holding | ||||||
| Temperature | 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
9
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 in
SBT (LoD)
from the PI | CFUs/mL in
SBT (2XLoD)
from the PI | Actual 2XLoD
concentration of each
strain in CFUs/mL
SBT |
|---------------------------------|---------------------------------|----------------------------------------|------------------------------------------|-------------------------------------------------------------------|
| BD MAX EBP
multiplex mix #1 | Campylobacter jejuni | 10 | 20 | 56 |
| BD MAX EBP
multiplex mix #1 | Shigella sonnei | 124 | 248 | 144 |
| BD MAX EBP
multiplex mix #2 | Escherichia coli STX1 | 223 | 446 | 361 |
| BD MAX EBP
multiplex mix #2 | Salmonella typhimurium | 193 | 386 | 373 |
| BD MAX xEBP
multiplex mix #1 | Yersinia enterocolitica | 227 | 454 | 576 |
| BD MAX xEBP
multiplex mix #1 | Escherichia coli ETEC | 137 | 274 | 361 |
| BD MAX xEBP
multiplex mix #2 | Vibrio parahaemolyticus | 124 | 248 | 396 |
| BD MAX xEBP
multiplex 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 shigelloides | ||||||
| ATCC 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 parahaemolyticus | ||||||
| ATCC 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 |
10
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.
| Specimen
storage
condition in
FecalSwab | Specimen
storage
condition in
SBT | Total
Days | Number
of
replicates
tested | Number of
replicates
providing
amplification for
SPC 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.