COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM

K142094 · Copan Italia Spa · JSM · Apr 10, 2015 · Microbiology

Device Facts

• Record ID: K142094
• Device Name: COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
• Applicant: Copan Italia Spa
• Product Code: JSM · Microbiology
• Decision Date: Apr 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2390
• Device Class: Class 1

Indications for Use

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.

Device Story

System consists of plastic screw-cap tube containing 2 ml transport/preservation medium and sterile nylon flocked swab; used for collection of rectal/fecal specimens. Device maintains viability of enteric pathogenic bacteria during transit from collection site to laboratory. Medium contains chloride salts, sodium salts, phosphate buffer, L-Cysteine, agar, and water. Upon arrival at laboratory, specimens processed via standard clinical culture procedures. Device facilitates transport of samples for investigation of enteric pathogens; benefits patient by ensuring specimen integrity for accurate diagnostic testing.

Clinical Evidence

No clinical testing was conducted. Bench testing only. Performance evaluated per CLSI M40-A2 standards. Bacterial recovery studies assessed viability of various enteric pathogens (e.g., E. coli, Salmonella, C. difficile, Campylobacter) in PBS and fecal matrix at room temperature and 2-8°C over 48-72 hours. Results demonstrated maintenance of viability comparable to the predicate.

Technological Characteristics

Transport medium (chloride/sodium salts, phosphate buffer, L-Cysteine, agar, water); pH 6.90–7.50. Collection tool: sterile nylon flocked swab with plastic shaft. Container: plastic tube. Sterilization: Gamma radiation (SAL 10^-6). Storage: 5-25 °C. Shelf life: 15 months.

Indications for Use

Indicated for the collection of rectal swab and fecal specimens to preserve the viability of enteric pathogenic bacteria during transport to a laboratory for culture.

Regulatory Classification

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.

Predicate Devices

• Copan Venturi Transystem Cary-Blair Medium (k946286)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM

A. 510(k) Number:
k142094

B. Purpose for Submission:
To provide data and information to support a substantial equivalence determination for the Copan Fecal Swab Collection, Transport and Preservation System for the collection of rectal swab and fecal specimens and the preservation of enteric pathogenic bacteria present in those specimens.

C. Measurand:
Not applicable.

D. Type of Test:
Culture media system for the collection, transport, and preservation of rectal swab and fecal specimens.

E. Applicant:
Copan Italia S.p.A.

F. Proprietary and Established Names:
Copan Fecal Swab Collection, Transport and Preservation System

G. Regulatory Information:
1. Regulation section:
21 CFR 866.2390; Transport culture medium
2. Classification:
Class I
3. Product code:
JSM: Culture media, non-propagating transport

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LIO: Device, specimen collection

4. Panel:
Microbiology (83)

H. Intended Use:

1. Intended use:
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.

2. Indication for use:
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.

3. Special conditions for use statements:
For in vitro diagnostic use only.
For prescription use only.

4. Special instrument requirements:
None.

I. Device Description:
The Copan FecalSwab Collection, Transport and Preservation System (FecalSwab) is supplied in a collection kit format. Each collection kit consists of a package containing a plastic screw-cap tube with conical shaped bottom filled with 2 ml of transport and preservation medium and a specimen collection swab that has a tip flocked with soft nylon fiber.

The FecalSwab transport and preservation medium is a maintenance medium designed to maintain the viability of enteric pathogenic bacteria during transit to the testing laboratory.

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The FecalSwab Transport and Preservation Medium is comprised of the following:

- Chloride salts
- Sodium salts
- Phosphate buffer
- L-Cysteine
- Agar
- Water

The nylon flocked specimen collection swabs provided with the Copan FecalSwab Collection, Transport and Preservation System have a solid plastic shaft with a molded breakpoint site and are sterile.

## J. Substantial Equivalence Information:

1. Predicate device name:
Copan Venturi Transystem Cary-Blair Medium

2. Predicate 510(k) number:
k946286

3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Copan FecalSwab Collection, Transport and Preservation System (k142094) | Copan Venturi Transystem Cary-Blair Medium (k946286) |
| Product Code | JSM, LIO | JSM |
| Intended Use | 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. | Copan Venturi Transystem Cary-Blair Medium product (132C) is a sterile ready-to-use system intended for the safe collection, transport, and preservation of clinical specimens for bacteriological examination. Product 132C is supplied with a plastic applicator swab. The Venturi Transystem with Cary-Blair Transport Medium is recommended for the collection and transport of fecal and rectal swab samples for the investigation of enteric pathogenic bacteria. |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Copan FecalSwab Collection, Transport and Preservation System (k142094) | Copan Venturi Transystem Cary-Blair Medium (k946286) |
| Product Configuration | Film-film peel-pouch containing 1 tube and 1 swab | Same |
| pH of Medium | 6.90 – 7.50 | Same |
| Storage Temperature | 5-25 °C | Same |
| Container | Tube; Plastic | Same |
| Collection tool | Swab | Same |
| Swab Shaft | Plastic | Same |
| Biocompatible | Yes | Same |
| Sterility | Gamma Radiation – SAL 10-6 | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Copan FecalSwab Collection, Transport and Preservation System (k142094) | Copan Venturi Transystem Cary-Blair Medium (k946286) |
| Medium Formulation | Chloride salts Sodium salts Phosphate buffer L-Cysteine Agar Water | Sodium chloride Calcium chloride Disodium hydrogen phosphate Sodium thioglycolate Agar Water |
| Performance | Viability of target micro-organisms up to 72 hours at 2 – 8 °C and up to 48 hours at 20 – 25 °C. For C. difficile, up to 48 hours at 2 – 8 °C and up to 24 hours at 20 – 25 °C. | Viability of target micro-organisms up to 48 hours at room temperature. |
| Medium State | Semi-solid | Solid |
| Medium Volume | 2 ml | 5 ml |
| Swab Tip | Flocked nylon | Viscose |
| Shelf Life | 15 months | 20 months |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Copan FecalSwab Collection, Transport and Preservation System (k142094) | Copan Venturi Transystem Cary-Blair Medium (k946286) |
| Microorganisms tested | Escherichia coli
Escherichia coli O157:H7
Salmonella typhimurium
Shigella sonnei
Campylobacter jejuni
Yersinia enterocolitica
Vibrio parahaemolyticus
Enterococcus faecalis
vancomycin resistant (VRE)
Clostridium difficile | Escherichia coli
Shigella flexneri
Campylobacter jejuni
Yersinia enterocolitica |

K. Standard/Guidance Documents Referenced:

Not applicable.

L. Test Principle:

Not applicable.

M. Performance Characteristics:

1. Analytical performance:

Recovery:

Bacterial recovery studies were performed using two methods based on CLSI M40-A2 to determine recovery of viable enteric organisms. Dilutions of representative enteric pathogenic microorganisms were prepared in physiological saline and used as inoculum.

For Method 1, 100 μL from each dilution of inoculum was added directly to the FecalSwab tube. For each inoculum concentration, one tube from each of three device lots was inoculated for each temperature / time storage condition. The inoculated tubes were stored at 2 – 8 °C for 0, 6, 24, 48 and 72 hours or at 20 – 25 °C for 0, 6, 24 and 48 hours. After storage, 100 μL from each device was transferred to each of three plates of appropriate culture medium and spread across the surface using a sterile spreader. The inoculated plates were incubated under appropriate conditions. Manual colony counts were performed. Plate counts from dilutions generating 25 – 250 colony forming units (CFU) were considered valid for determining the organism concentration. The average CFU from the nine plates (three plates per lot x three lots) for each temperature / time storage condition was compared to the CFU at time zero.

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For Method 2, $100~\mu \mathrm{L}$ from each dilution of inoculum was absorbed by each of three swabs from each of three lots of Copan FecalSwab System. The swab was then added to the device tube. The inoculated tubes were stored at $2 - 8^{\circ}\mathrm{C}$ for 0, 6, 24, 48 and 72 hours or at $20 - 25^{\circ}\mathrm{C}$ for 0, 6, 24 and 48 hours. After storage, the swab was removed from the device and used to streak a plate of the appropriate culture medium. The inoculated plates were incubated for 24 hours under appropriate conditions. Manual colony counts were performed. Plate counts from dilutions generating $25 - 250$ CFU were considered valid. The average CFU from nine plates (three plates per lot x three lots) for each time / temperature storage condition was compared to the CFU at time zero.

The acceptance criterion for Method 1 and Method 2 was an average CFU for the stored FecalSwab Systems that was within $2\log_{10}$ of the time zero CFU.

Recovery of the following microorganisms from physiological saline was evaluated:

| Escherichia coli | ATCC 25922 |
| --- | --- |
| Escherichia coli O157:H7 | ATCC 700728 * |
| Salmonella typhimurium | ATCC 14028 |
| Shigella sonnei | ATCC 12022 |
| Clostridium difficile | ATCC 9689 * |
| Vibrio parahaemolyticus | ATCC 17802 |
| Enterococcus faecalis vancomycin resistant (VRE) | ATCC 51299 |
| Yersinia enterocolitica | ATCC 9610 |
| Campylobacter jejuni | ATCC 33291 |

* Tested using Method 2 only.

Results met the acceptance criteria for each microorganism and each time / temperature storage condition with both Method 1 and Method 2, except for C. difficile which demonstrated acceptable recovery after 24 hours when stored at $20 - 25^{\circ}\mathrm{C}$ and after 48 hours when stored at $2 - 8^{\circ}\mathrm{C}$ . Escherichia coli O157:H7 and Clostridium difficile were tested with Method 2 only.

Method 1. Recovery Results after Inoculation with Microorganism Diluted in Physiological Saline. The average CFU/mL was calculated using results from the inoculum dilution that produced counts of 25 - 250 colonies / plate.

| | | Average CFU/mL recovered (n = 9) | | | | | Log reduction (-) or log increase (+)a |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Organism | Hold Temp. | Time 0 hrs | Time 6 hrs | Time 24 hrs | Time 48 hrs | Time 72 hrs | |
| E. coli | 2-8 °C | 1640 | 1487 | 1157 | 821 | 608 | -0.43 |
| | 20-25 °C | 1640 | 1747 | 13200 | 33500 | NA | 1.31 |
| S. typhimurium | 2-8 °C | 2200 | 1813 | 1780 | 2017 | 1667 | -0.12 |
| | 20-25 °C | 2200 | 5010 | 22000 | 166000 | NA | 1.88 |
| S. sonnei | 2-8 °C | 2223 | 1853 | 2173 | 1963 | 1787 | -0.09 |
| | 20-25 °C | 2223 | 5143 | 23100 | 180000 | NA | 1.91 |
| V. parahaemolyticus | 2-8 °C | 2197 | 1357 | 1970 | 1647 | 1423 | -0.19 |
| | 20-25 °C | 2197 | 8953 | 22567 | 176667 | NA | 1.91 |

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| | | Average CFU/mL recovered (n = 9) | | | | | Log reduction (-) or log increase (+)a |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Organism | Hold Temp. | Time 0 hrs | Time 6 hrs | Time 24 hrs | Time 48 hrs | Time 72 hrs | |
| E. faecalis (VRE) | 2-8 °C | 2023 | 1717 | 1767 | 1547 | 1363 | -0.17 |
| | 20-25 °C | 2023 | 1950 | 4553 | 34900 | NA | 1.24 |
| Y. enterocolitica | 2-8 °C | 1583 | 1473 | 1470 | 1410 | 1440 | -0.04 |
| | 20-25 °C | 1583 | 5933 | 17533 | 104333 | NA | 1.82 |
| C. jejuni | 2-8 °C | 2190 | 2060 | 1463 | 478 | 180 | -1.09 |
| | 20-25 °C | 2190 | 1787 | 1463 | 57 | NA | -1.58 |

$^{\mathrm{a}}$ at time 72 hrs for $2 - 8^{\circ}\mathrm{C}$ hold temperature or at time 48 hrs for $20 - 25^{\circ}\mathrm{C}$ hold temperature
NA - not applicable; devices held at $20 - 25^{\circ}\mathrm{C}$ were not tested at 72 hours.

Method 2. Recovery Results after Inoculation with Microorganism Diluted in Physiological Saline. The average CFU/swab was calculated using results from the inoculum dilution that produced counts of 25 - 250 colonies / plate.

| | | Average CFU/swab recovered (n = 9) | | | | | Log reduction (-) or log increase (+)a |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Organism | Hold Temp. | Time 0 hrs | Time 6 hrs | Time 24 hrs | Time 48 hrs | Time 72 hrs | |
| E. coli | 2-8 °C | 107 | 112 | 85 | 83 | 73 | -0.17 |
| | 20-25 °C | 107 | 135 | 1323 | 5723 | NA | 1.73 |
| E. coli O157:H7 | 2-8 °C | 90 | 101 | 104 | 107 | 104 | 0.06 |
| | 20-25 °C | 90 | 128 | 257 | 4117 | NA | 1.66 |
| S. typhimurium | 2-8 °C | 138 | 141 | 159 | 158 | 97 | -0.15 |
| | 20-25 °C | 138 | 584 | 2273 | 9723 | NA | 1.85 |
| S. sonnei | 2-8 °C | 127 | 126 | 42 | 146 | 116 | -0.04 |
| | 20-25 °C | 127 | 476 | 1910 | 9667 | NA | 1.88 |
| C. difficile | 2-8 °C | 44 | 23 | 6 | 1 | * | -1.85** |
| | 20-25 °C | 44 | 18 | 1 | * | NA | -1.92** |
| V. parahaemolyticus | 2-8 °C | 200 | 178 | 176 | 168 | 154 | -0.11 |
| | 20-25 °C | 200 | 222 | 1623 | 15833 | NA | 1.90 |
| E. faecalis (VRE) | 2-8 °C | 168 | 167 | 152 | 438 | 116 | -0.16 |
| | 20-25 °C | 168 | 170 | 439 | 2260 | NA | 1.13 |
| Y. enterocolitica | 2-8 °C | 117 | 114 | 112 | 109 | 104 | -0.05 |
| | 20-25 °C | 117 | 172 | 1243 | 9777 | NA | 1.92 |
| C. jejuni | 2-8 °C | 214 | 166 | 133 | 86 | 34 | -0.80 |
| | 20-25 °C | 214 | 168 | 58 | 4 | NA | -1.70 |

$^{\mathrm{a}}$ at time 72 hrs for $2 - 8^{\circ}\mathrm{C}$ hold temperature or at time 48 hrs for $20 - 25^{\circ}\mathrm{C}$ hold NA – not applicable; devices held at $20 - 25^{\circ}\mathrm{C}$ were not tested at 72 hours.
* Result did not meet the acceptance criterion. A limitation was added to the package insert for recovery of C. difficile after up to 48 hours of hold time at $2 - 8^{\circ}\mathrm{C}$ and up to 24 of hold time at $20 - 25^{\circ}\mathrm{C}$ .
** Log difference at Time 48 hours for hold at $2 - 8^{\circ}\mathrm{C}$ and at Time 24 hours for hold at $20 - 25^{\circ}\mathrm{C}$ .

Recovery was also evaluated using representative pathogenic enteric microorganisms spiked into a solution of fecal matrix and tested with Method 2 as described above. To prepare the fecal matrix, stools from three healthy volunteers were pooled and added to

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PBS in sufficient quantity to ensure that the final matrix contained at least 30% stool. Testing was performed as described for Method 2 above. Appropriate selective media were used to allow differentiation of the test microorganisms from the normal flora found in stool samples.

The acceptance criterion for recovery from fecal matrix was an average CFU for the stored FecalSwab Systems that was within 2 log₁₀ of the time zero CFU.

Recovery of the following microorganisms from fecal matrix was evaluated:

Escherichia coli O157:H7 ATCC 700728

Salmonella typhimurium ATCC 14028

Vibrio parahaemolyticus ATCC 17802

Results met the acceptance criterion for each microorganism and each time / temperature storage condition. Results for recovery of microorganisms from a fecal matrix are shown in the following table.

Method 2 Recovery Results for after Inoculation with Microorganism Diluted in Fecal Matrix. The average CFU/swab was calculated using results from the inoculum dilution that produced counts of 25 – 250 colonies / plate.

| | | Average CFU/swab recovered (n = 9) | | | | | Log reduction (-) or log increase (+)a |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Organism | Hold Temp. | Time 0 hrs | Time 6 hrs | Time 24 hrs | Time 48 hrs | Time 72 hrs | |
| E.coli O157:H7 | 2-8 °C | 123 | 137 | 138 | 153 | 160 | 0.11 |
| | 20-25 °C | 123 | 134 | 748 | 7537 | NA | 1.79 |
| S. typhimurium | 2-8 °C | 95 | 105 | 120 | 132 | 143 | 0.18 |
| | 20-25 °C | 95 | 117 | 651 | 6380 | NA | 1.83 |
| V. parahaemolyticus | 2-8 °C | 111 | 121 | 129 | 126 | 136 | 0.09 |
| | 20-25 °C | 111 | 134 | 1141 | 7357 | NA | 1.82 |

a at time 72 hrs for 2 - 8 °C hold temperature or at time 48 hrs for 20 - 25 °C hold NA - not applicable; devices held at 20 - 25 °C were not tested at 72 hours.

Overgrowth:

No overgrowth limit is defined by CLSI M40-A2 for devices held at room temperature (20-25 °C) because most commercial transport media cannot control for it. The capacity of the Copan FecalSwab System to inhibit overgrowth of normal flora found in stool specimens was evaluated using the procedure described for Method 2 above. A solution of Pseudomonas aeruginosa was prepared in physiological saline and used to inoculate three FecalSwab tubes from each of six lots. The inoculated tubes were stored at 2 - 8 °C for 0, 24, or 48 hours. After storage, the swab was removed and used to streak the surface of a nonselective culture plate.

The acceptance criterion was ≤ 1 log₁₀ increase in CFU, relative to time zero, after storage of the FecalSwab tubes at 2 - 8 °C for 48 hours.

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All FecalSwab tubes met the acceptance criterion, showing less than a 1 log increase in CFU, relative to time zero, for swabs stored at $2 - 8^{\circ}\mathrm{C}$ for 48 hours.

## Bio-Burden:

Testing was performed in accordance with M40-A2. Ten FecalSwab kits from each of three lots were included in the testing.

The acceptance criterion was $\leq 2$ bacteria in 10 microscopic fields examined for each slide. All 10 of the FecalSwab kits from each of the three lots met the acceptance criterion of less than or equal to two bacteria in 10 microscopic fields.

### a. Precision/Reproducibility:

Not applicable.

### b. Linearity/assay reportable range:

Not applicable.

### c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Shelf-life testing was performed at months 1, 8 and 16 after storage at $2 - 6^{\circ}\mathrm{C}$ or $28 - 32^{\circ}\mathrm{C}$. Three lots of the Copan FecalSwab Collection, Transport and Preservation System were included in the study. Stability was evaluated by testing for:

- pH

Acceptance criterion: pH must remain within the target range of 6.90 – 7.50

- Bacterial recovery of *Escherichia coli*, *Salmonella typhimurium* and *Shigella sonnei*. After storage under the designated conditions, the devices were inoculated and held at $2 - 8^{\circ}\mathrm{C}$ or $20 - 25^{\circ}\mathrm{C}$ prior to plating. The inoculation and plating methods described for Method 1 and Method 2 above were included in the study.

Acceptance criterion: the average CFU must remain within $2\log_{10}$ of the initial time zero CFU.

## Results of the shelf life testing:

- The target pH range for the medium of 6.90 – 7.50 was maintained for all devices at each time point.
- The acceptance criterion of average CFU remaining within $2\log_{10}$ of the initial microorganism CFU was met for all bacterial strains and each test condition.

These data demonstrate the ability of the Copan FecalSwab System to maintain pH

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and bacterial viability under the intended use conditions and support the shelf life claim of 15 months from the date of manufacture.

d. Detection limit:
Not applicable.

e. Analytical specificity:
Not applicable.

f. Assay cut-off:
Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:
Method comparison is not applicable for a bacterial transport medium. The device itself does not provide a result that can be used in making a clinical decision.

Bench testing studies were performed to determine the ability of the Copan Fecal Swab Collection, Transport and Preservation System to maintain viability of different strains of pathogenic enteric bacteria. Results of these studies demonstrated recovery of bacteria within the acceptance criteria recommended in CLSI M40-A2. Refer to Analytical Performance in Section M.1 above.

b. Matrix comparison:
Not applicable.

3. Clinical studies:

a. Clinical Sensitivity:
Not applicable.

b. Clinical specificity:
Not applicable.

c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable.

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4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
Not applicable.

N. Proposed Labeling:
The labeling is sufficient and satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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