Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device

K242976 · Medical Wire & Equipment Company (Bath), Ltd. · JSM · Nov 26, 2025 · Microbiology

Device Facts

• Record ID: K242976
• Device Name: Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device
• Applicant: Medical Wire & Equipment Company (Bath), Ltd.
• Product Code: JSM · Microbiology
• Decision Date: Nov 26, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2390
• Device Class: Class 1

Indications for Use

The Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device is intended to preserve the viability and infectivity of fecal specimens after their collection and during transport from the collection site to the testing laboratory. The product can be used to collect stool specimen directly from the patient, using the swab as a rectal swab. Alternatively, the swab can be used to take material from a previously collected stool specimen. Fecal Transwab specimens are processed using standard clinical laboratory operating procedures for microbiological specimens.

Device Story

Device consists of sterile peel pouch containing plastic screw-cap conical tube with 2 ml Liquid Cary Blair transport medium and polyurethane foam-tipped collection swab. Used by clinicians to collect stool or rectal specimens; swab applicator placed in tube with bud bathed in medium; shaft broken at defined breakpoint. Medium maintains viability of enteric bacteria during transit to laboratory. Laboratory personnel process specimens using standard microbiological procedures. Benefits include preservation of specimen integrity for accurate diagnostic testing.

Clinical Evidence

Bench testing only. Recovery studies performed per CLSI M40-A2 using 10 recognized fecal bacterial strains in 50% fecal matrix. Evaluated recovery after storage at refrigeration (2-8°C) and room temperature (20-25°C). All organisms met acceptance criteria for 48-hour recovery, except Clostridium difficile (24-hour recovery). Shelf-life stability confirmed for 24 months.

Technological Characteristics

Transport medium: Potassium di-hydrogen phosphate, Di-sodium hydrogen phosphate, Sodium thioglycollate, Sodium chloride, Calcium chloride, Deionized water. Foam-tipped swab with solid plastic shaft and molded breakpoint. Conical screw-cap tubes (12x80mm or 16x100mm). Sterile. Shelf-life: 24 months. Complies with CLSI M40-A2.

Indications for Use

Indicated for the collection, transport, and preservation of rectal swab and fecal specimens for the recovery of enteric pathogenic bacteria. For prescription use only.

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 Fecalswab Collection, Transport And Preservation System (K142094)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K242976

B Applicant

Medical Wire & Equipment Company (Bath) Ltd

C Proprietary and Established Names

Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JSM | Class I, reserved | 21 CFR 866.2390 - Transport Culture Medium | MI - Microbiology |

## II Submission/Device Overview:

A Purpose for Submission:

To make a substantial equivalence determination for the Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device for the collection, transport and storage of fecal specimens for laboratory culture of bacteria.

B Measurand:

Not Applicable

C Type of Test:

Culture media system for the collection, transport, and preservation of rectal swab and fecal specimens

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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## III Intended Use/Indications for Use:

### A Intended Use(s):
See Indications for Use below.

### B Indication(s) for Use:
The Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device is intended to preserve the viability and infectivity of fecal specimens after their collection and during transport from the collection site to the testing laboratory. The product can be used to collect stool specimen directly from the patient, using the swab as a rectal swab. Alternatively, the swab can be used to take material from a previously collected stool specimen. Fecal Transwab specimens are processed using standard clinical laboratory operating procedures for microbiological specimens.

### C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only

### D Special Instrument Requirements:
None

## IV Device/System Characteristics:

### A Device Description:
The Medical Wire Fecal Transwab Liquid (Cary Blair) Medium Collection and Transport Device (referred to as Fecal Transwab System below) 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 Cary Blair medium, co-packaged with a foam tip swab. The kit comes in four different configurations, 1) 2 mL of media in a 12mmX80mm vial without a swab, 2) 2mL of media in a 12mmX80mm vial with a foam tipped swab, 3) 2 mL of media in a 16mmX100mm vial without a swab, and 4) 2mL of media in a 116mmX100mm vial with a foam tipped swab.

### B Principle of Operation:
The Transwab transport and preservation medium is a maintenance medium designed to maintain the viability of enteric pathogenic bacteria during transit to the testing laboratory. The Transwab Transport and Preservation Medium is comprised of the following:

- Potassium di-hydrogen phosphate
- Di-sodium hydrogen phosphate
- Sodium thioglycollate
- Sodium chloride
- Calcium chloride
- Deionized water

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The foam tipped swab provided with the Transwab has a solid plastic shaft with a molded breakpoint site and is sterile.

V Substantial Equivalence Information:

A Predicate Device Name(s):

Copan Fecalswab Collection, Transport And Preservation System,

B Predicate 510(k) Number(s):

K142094

C Comparison with Predicate(s):

| Device & Predicate Device(s): | Device: K242976 | Predicate: K142094 |
| --- | --- | --- |
| Device Trade Name | Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device | Copan FecalSwab Collection, Transport and Preservation System |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device is intended to preserve the viability and infectivity of fecal specimens after their collection and during transport from the collection site to the testing laboratory. The product can be used to collect stool specimen directly from the patient, using the swab as a rectal swab. Alternatively, the swab can be used to take material from a previously collected stool specimen. Fecal Transwab specimens are processed using standard clinical laboratory operating procedures for microbiological specimens. | 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 | Same |
| Microorganisms supported | Enteric pathogenic bacteria | Same |
| Tube configuration | Conical tubes with screw caps | Same |

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| Kit configuration comes with a swab | Swab included | Same |
| --- | --- | --- |
| Media volume | 2mL | Same |
| General Device Characteristic Differences | | |
| Microorganisms tested | Escherichia coli
Salmonella typhimurium
Shigella sonnei
Campylobacter jejuni
Yersinia enterocolitica
Vibrio parahaemolyticus
Enterococcus faecalis
Plesiomonas shigelloides
Escherichia coli O157:H7
Clostridium difficile | Escherichia coli
Escherichia coli O157:H7
Salmonella typhimurium
Shigella sonnei
Campylobacter jejuni
Yersinia enterocolitica
Vibrio parahaemolyticus
Enterococcus faecalis
vancomycin resistant (VRE)
Clostridium difficile |
| Medium formulation | Potassium di-hydrogen phosphate
Di-sodium hydrogen phosphate
Sodium thioglycollate
Sodium chloride
Calcium chloride
Deionized water | Chloride salts
Sodium salts
Phosphate buffer
L-Cysteine
Agar
Water |
| Shelf-life | 24 months | 15 months |
| Specific swab type | Foam tip | Flocked nylon tip |

VI Standards/Guidance Documents Referenced:

CLSI M40-A2 Quality Control of Microbiological Transport Systems

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:
N/A

2. Linearity:
N/A

3. Analytical Specificity/Interference:
N/A

4. Assay Reportable Range:
N/A

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# 5. Stability/Shelf-life

Shelf-life stability testing was performed using a real-time study design with seven lots of media. Media was evaluated for the following parameters: pH, Gram stain, fill volume, clarity, color, vial integrity and swab packaging integrity. Recovery of microorganisms from fecal matrix was assessed by the Roll Plate method and swab elution, as described in A.6 below. The data support stability for up to 24 months at room temperature.

# 6. Bacterial Recovery:

Bacterial recovery studies were performed using two methods, roll plate and swab elution, based on CLSI M40-A2 to determine recovery of viable enteric organisms. Dilutions of representative enteric pathogenic microorganisms were prepared in saline and mixed 1:5 with 50% negative clinical matrix (bulk negative clinical stool matrix was mixed 50:50 with saline to maintain consistency) prior to transfer into the media for each method.

Recovery of the following microorganisms from physiological saline was evaluated using both the roll plate and the swab elution method: Campylobacter jejuni ATCC 33291, Enterococcus faecalis ATCC 29212, Escherichia coli ATCC 25922, Salmonella typhimurium ATCC 14028, Shigella sonnei (flexneri) ATCC 12022, Vibrio parahaemolyticus ATCC 17802, Yersinia enterocolitica ATCC 9610, Plesiomonas shigelloides ATCC 14029, Escherichia coli O157:H7 ATCC 700728, and Clostridium difficile ATCC 9689.

For the roll plate method, 100 μL from each diluted organism inoculum was mixed with 500 μL of 50% negative clinical matrix. The mixture was then added directly to the Fecal Transwab 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 held at 2-8 °C for 0, 24, and 48 hours or at 20-25 °C for 0, 24 and 48 hours for all claimed organisms except C. diff. C. diff was held at both 2-8 °C and 20-25 °C for 0 and 24 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, as shown in Table 1. The acceptance criterion for roll plate recovery was an average CFU for the stored Fecal Transwab Systems that was within 200 CFUs of the time zero CFU in table 2.

Table 1. Roll plate method recovery results using the Fecal Transwab System.

| Organism | Temperature | Time Point | Average CFU Count | Change from T_{0} |
| --- | --- | --- | --- | --- |
| Vibrio parahaemolyticus | N/A | T_{0} | 220 | 0 |
| | 2-8°C | 24h | 248 | +28 |
| | | 48h | 276 | +56 |
| | 20-25°C | 24h | 308 | +88 |

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| Organism | Temperature | Time Point | Average CFU Count | Change from T_{0} |
| --- | --- | --- | --- | --- |
| | | 48h | 395 | +175 |
| Enterococcus faecalis | N/A | T_{0} | 158 | 0 |
| | 2-8°C | 24h | 159 | +1 |
| | | 48h | 150 | -8 |
| | 20-25°C | 24h | 215 | +67 |
| | | 48h | 275 | +117 |
| Yersinia enterocolitica | N/A | T_{0} | 225 | 0 |
| | 2-8°C | 24h | 205 | -20 |
| | | 48h | 168 | -67 |
| | 20-25°C | 24h | 225 | 0 |
| | | 48h | 236 | +11 |
| Escherichia coli | N/A | T_{0} | 218 | 0 |
| | 2-8°C | 24h | 207 | -11 |
| | | 48h | 207 | -11 |
| | 20-25°C | 24h | 350 | +132 |
| | | 48h | 376 | +158 |
| Salmonella typhimurium | N/A | T_{0} | 218 | 0 |
| | 2-8°C | 24h | 214 | -4 |
| | | 48h | 207 | -11 |
| | 20-25°C | 24h | 355 | -137 |
| | | 48h | 332 | -114 |
| Campylobacter jejuni | N/A | T_{0} | 222 | 0 |
| | 2-8°C | 24h | 161 | -61 |
| | | 48h | 113 | -109 |
| | 20-25°C | 24h | 89 | -133 |
| | | 48h | 33 | -189 |
| Plesiomonas shigelloides | N/A | T_{0} | 198 | 0 |
| | 2-8°C | 24h | 189 | -9 |
| | | 48h | 164 | -34 |
| | 20-25°C | 24h | 198 | -0 |
| | | 48h | 177 | -21 |
| Shigella flexneri | N/A | T_{0} | 186 | 0 |
| | 2-8°C | 24h | 184 | -2 |
| | | 48h | 152 | -34 |
| | 20-25°C | 24h | 177 | -9 |
| | | 48h | 128 | -56 |
| E. coli 0157:H7 | N/A | T_{0} | 228 | 0 |
| | 2-8°C | 24h | 317 | +89 |
| | | 48h | 228 | 0 |
| | 20-25°C | 24h | 315 | +87 |
| | | 48h | 459 | +231 |
| Clostridium difficile | N/A | T_{0} | 222 | 0 |
| | 2-8°C | 24h | 85 | -137 |
| | 20-25°C | 24h | 32 | -190 |

For the swab elution method, 100 µL from each dilution of inoculum was absorbed by each of three swabs from each of three lots of Fecal Transwab System. The swab was then added to the device tube. The inoculated tubes were held at 2-8 °C for 0, 24, and 48 hours or at 20-25 °C for 0, 24 and 48 hours for all claimed organisms except C. diff. C. diff was held at both 2-8 °C and 20-25 °C for 0 and 24 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

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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, as shown in Table 2. The acceptance criterion for swab elution recovery was an average CFU for the stored Fecal Transwab Systems that was within 3 log10 of the time zero CFU in table 2.

Table 2. Swab elution recovery results using the Fecal Transwab System.

| Organism | Temperature | Time Point | Average CFU Count | Log10Count | Log Change from T0 |
| --- | --- | --- | --- | --- | --- |
| Vibrio parahaemolyticus | N/A | T0 | 2.1×104 | 4.32 | 0.00 |
| | 2-8°C | 24h | 4.1×104 | 4.61 | +0.29 |
| | | 48h | 3.5×104 | 4.54 | +0.22 |
| | 20-25°C | 24h | 4.2×105 | 5.62 | +1.30 |
| | | 48h | 3.5×104 | 4.54 | +0.22 |
| Enterococcus faecalis | N/A | T0 | 1.6 × 105 | 5.20 | 0.00 |
| | 2-8°C | 24h | 1.5×105 | 5.18 | -0.02 |
| | | 48h | 1.1×105 | 5.04 | -0.16 |
| | 20-25°C | 24h | 1.8×105 | 5.26 | +0.06 |
| | | 48h | 1.7×105 | 5.23 | +0.03 |
| Yersinia enterocolitica | N/A | T0 | 1.1×105 | 5.04 | 0.00 |
| | 2-8°C | 24h | 1.3×105 | 5.11 | +0.07 |
| | | 48h | 1.1×105 | 5.04 | 0.00 |
| | 20-25°C | 24h | 4.6×105 | 5.66 | +0.62 |
| | | 48h | 1.7×106 | 6.23 | +1.19 |
| Escherichia coli | N/A | T0 | 2.3×105 | 5.36 | 0.00 |
| | 2-8°C | 24h | 1.3×105 | 5.11 | -0.25 |
| | | 48h | 6.6×104 | 4.82 | -0.54 |
| | 20-25°C | 24h | 5.0×105 | 5.70 | +0.34 |
| | | 48h | 2.1×106 | 6.32 | +0.96 |
| Salmonella typhimurium | N/A | T0 | 6.1×105 | 5.79 | 0.00 |
| | 2-8°C | 24h | 5.9×105 | 5.77 | -0.02 |
| | | 48h | 3.3×105 | 5.52 | -0.27 |
| | 20-25°C | 24h | 6.6×105 | 5.82 | +0.03 |
| | | 48h | 1.6×106 | 6.20 | +0.41 |
| Campylobacter jejuni | N/A | T0 | 3.7×105 | 5.57 | 0.00 |
| | 2-8°C | 24h | 4.1×105 | 5.61 | +0.04 |
| | | 48h | 3.3×105 | 5.52 | -0.05 |
| | 20-25°C | 24h | 9.2×104 | 4.96 | -0.61 |
| | | 48h | 4.2×103 | 3.62 | -1.95 |
| Plesiomonas shigelloides | N/A | T0 | 2.2×105 | 5.34 | 0.00 |
| | 2-8°C | 24h | 1.9×105 | 5.28 | -0.06 |
| | | 48h | 1.3×105 | 5.11 | -0.23 |
| | 20-25°C | 24h | 1.1×105 | 5.04 | -0.30 |
| | | 48h | 5.9×104 | 4.77 | -0.57 |
| Shigella flexneri | N/A | T0 | 1.8×105 | 5.26 | 0.00 |
| | 2-8°C | 24h | 1.4×105 | 5.15 | -0.11 |
| | | 48h | 1.2×105 | 5.08 | -0.18 |
| | 20-25°C | 24h | 1.3×105 | 5.11 | -0.15 |
| | | 48h | 5.9×104 | 4.77 | -0.49 |
| E. coli 0157:H7 | N/A | T0 | 1.5×105 | 5.18 | 0.00 |
| | 2-8°C | 24h | 1.5×105 | 5.18 | 0.00 |
| | | 48h | 8.2×104 | 4.91 | -0.27 |
| | 20-25°C | 24h | 4.3×105 | 5.63 | +0.45 |
| | | 48h | 7.4×105 | 5.87 | +0.69 |
| Clostridium difficile | N/A | T0 | 5.9×104 | 4.77 | 0.00 |

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| Organism | Temperature | Time Point | Average CFU Count | Log_{10} Count | Log Change from T_{0} |
| --- | --- | --- | --- | --- | --- |
| | 2-8°C | 24h | 3.5×10^{4} | 4.54 | -0.23 |
| | 20-25°C | 24h | 4.2×10^{2} | 2.62 | -2.15 |

The data provided and summarized in tables 1 and 2 met the predefined acceptance criteria when stored at refrigeration (2-8 °C) and room temperature (20-25 °C) and tested at 24 and 48 hrs., except for C. difficile that demonstrated adequate recovery up to 24hrs.

7. Assay Cut-Off:
N/A

B Comparison Studies:
1. Method Comparison with Predicate Device:
N/A
2. Matrix Comparison:
N/A

C Clinical Studies:
1. Clinical Sensitivity:
N/A
2. Clinical Specificity:
N/A
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
N/A

D Clinical Cut-Off:
N/A

E Expected Values/Reference Range:
N/A

VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.

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IX Conclusion:

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

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