Puritan Fecal Opti-Swab Collection and Transport System

K162284 · Puritan Medical Products, LLC · JSM · Nov 4, 2016 · Microbiology

Device Facts

• Record ID: K162284
• Device Name: Puritan Fecal Opti-Swab Collection and Transport System
• Applicant: Puritan Medical Products, LLC
• Product Code: JSM · Microbiology
• Decision Date: Nov 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2390
• Device Class: Class 1

Indications for Use

Puritan Fecal Opti-Swab Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture.

Device Story

Device consists of sterile polyester flock swab applicator and polypropylene vial containing 2 mL nonnutritive balanced salt transport medium. Used by clinicians to collect fecal/rectal specimens; specimens placed in vial for transport to laboratory. Medium uses phosphate buffer, chloride salts, sodium thioglycolate, and L-cysteine to maintain osmotic balance and oxygen-reduced environment for enteric bacteria. Supports viability of organisms like C. difficile, E. coli, and Salmonella during transport. Enables laboratory culture and examination. Benefits patient by ensuring specimen integrity and accurate diagnostic results.

Clinical Evidence

Bench testing only. Recovery testing performed per CLSI M40-A2 guidelines comparing subject device to predicate using ATCC and clinical strains (e.g., C. difficile, E. coli, Salmonella). Fecal matrix challenge testing confirmed no adverse impact from fecal material. Stability and pH testing verified performance over 15-month shelf life. Cytotoxicity testing per ISO Elution Method-1X MEM Extract showed no evidence of cytotoxicity.

Technological Characteristics

System includes polyester flock swab and polypropylene vial with 2 mL medium (balanced salt solution, phosphate buffer, chloride salts, L-cysteine, sodium thioglycolate, agar). pH range 6.90-7.50. Sterilized by gamma irradiation per ANSI/AAMI/ISO 11137:2006. Storage 2-25°C.

Indications for Use

Indicated for the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria for bacteriological examination and culture. 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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
K162284

B. Purpose for Submission:
To make a substantial equivalence determination for the Puritan® Fecal Opti-Swab™ Collection and Transport System for the collection, transport and storage of fecal specimens for laboratory culture of bacteria and yeast.

C. Measurand:
Not applicable.

D. Type of Test:
Collection and transport culture medium device

E. Applicant:
Puritan Medical Products, LLC

F. Proprietary and Established Names:
Puritan® Fecal Opti-Swab™ Collection and Transport System

G. Regulatory Information:
1. Regulation section:
866.2390; Transport Culture Medium
2. Classification:
Class I
3. Product code:
JSM: Culture Media, Non-Propagating Transport
LIO: Device, Specimen Collection
JTW: System, Transport, Aerobic

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JTX: Trasport Systems, Anaerobic

4. Panel:
83- Microbiology

H. Intended Use:

1. Intended use(s):
Puritan Fecal Opti-Swab Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture.

2. Indication(s) for use:
Same as intended use.

3. Special conditions for use statement(s):
For prescription use only.

4. Special instrument requirements:
None.

I. Device Description:

Puritan Fecal Opti-Swab Collection and Transport System is comprised of a peel pouch containing a rayon tipped swab applicator for collecting specimens and a polypropylene, round-bottomed, capped tube containing 2 ml of a modified s Cary-Blair medium.

Cary-Blair medium is a non-nutritive balanced salt solution containing disodium phosphate to provide buffering capability, sodium chloride and calcium chloride to provide essential ions that help maintain osmotic balance. Agar is used to increase the viscosity of the medium. Sodium thioglycollate and L-cysteine helps maintain an oxygen-reduced environment to help maintain the viability of enteric bacteria during the transport to the laboratory.

The liquid modified Cary Blair medium is composed of the following components:

- Sodium chloride
- Disodium Phosphate
- Sodium thioglycollate
- Calcium chloride

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L-cysteine
- Bacteriological agar
- Deionized water

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Copan FecalSwab Collection, Transport and Preservation System

2. Predicate 510(k) number(s):

K142094

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Puritan Fecal Opti-Swab Collection and Transport System (K162284) | Copan FecalSwab Collection, Transport and Preservation System (K142094) |
| Intended Use | Puritan Fecal Opti-Swab Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture. | 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 Storage | For C. difficile, up to 48 hours at 2 – 8 °C and up to 24 hours at 20 – 25 °C. For other target organisms organisms: up to 72 hours at 2 – 8 °C and up to 48 hours at 20 – 25 °C. | Same |
| Shelf life | 15 months | Same |
| Medium Volume | 2 mL | Same |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Puritan Fecal Opti-Swab Collection and Transport System (K162284) | Copan FecalSwab Collection, Transport and Preservation System (K142094) |
| Single Use Device | Yes | Same |
| Tube | Polypropylene, conical with screw cap | Same |
| Packaging | Peel pouch | Same |
| Swab | Flocked rayon | Same |
| Organisms Tested | Campylobacter jejuni
Clostridium difficile
Enterococcus faecalis
Escherichia coli
Salmonella typhimurium
Shigella sonnei
Vibrio parahaemolyticus
Yersinia enterocolitica | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Puritan Fecal Opti-Swab Collection and Transport System (K162284) | Copan FecalSwab Collection, Transport and Preservation System (K142094) |
| Medium Formulation | Sodium chloride
Disodium Phosphate
Sodium thioglycollate
L-cysteine
Calcium chloride
Bacteriological agar
Deionized water | Chloride salts
Sodium salts
Phosphate buffer
L-cysteine
Agar
Water |
| Medium | Liquid | Semi-solid |

# K. Standard/Guidance Document Referenced (if applicable):

Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition, M40-A2, Clinical and Laboratory Standards Institute (CLSI), Wayne, PA, 2014.

# L. Test Principle:

Not applicable.

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:

The performance of the Puritan Fecal Opti-Swab Collection and Transport System was determined using roll plate and swab elution techniques outlined in the Clinical and Laboratory Standards Institute (CLSI) M40-A2 document. Bacterial viability studies were performed. The swabs from each transport system were inoculated with a specified volume of bacterial concentrations prepared in a fecal matrix and/or 0.85% phosphate buffered saline (PBS). A select group of organisms were also tested in a fecal matrix (See Table 1). Fecal matrix was made by diluting pre-screened negative fresh clinical fecal material in 0.85% PBS to a 30% concentration by volume.

These swabs were then placed in their respective transport tubes and held at various time intervals; at the designated time intervals the swabs were removed and processed. To test the viability at various time intervals the inoculated swabs were held at room temperature for 0, 24, and 48 hours and refrigerated for 0, 24, 48, and 72 hours.

The nine ATCC strains listed in Table 1 below were used in this study to evaluate the performance of the Puritan Fecal Opti-Swab Collection and Transport System. This device was tested using the swabs included with the transport kit. Viability studies were conducted in duplicate at 0, 24, and 48 at room temperature (20-25°C) and at 0, 24, 48, and 72 hours at refrigerated temperatures (2-8°C) using the Roll-Plate and Swab Elution Methods for all strains except C. difficile. For C. difficile, viability studies were conducted in duplicate at 0 and 48 at room temperature (20-25°C) and at 0, 24 and 48 hours at refrigerated temperatures (2-8°C) using the Roll-Plate and Swab Elution Methods.

| Table 1: Enteric bacteria evaluated for stability in Puritan Fecal Opti-Swab Collection and Transport System | | | |
| --- | --- | --- | --- |
| Microorganism | ATCC # | Fecal Matrix* | 0.85% Saline* |
| Campylobacter jejuni | ATCC 33291 | NO | YES |
| Clostridium difficile | ATCC 9689 | NO | YES |
| Enterococcus faecalis, Vancomycin-resistant (VRE) | ATCC 51299 | NO | YES |
| Escherichia coli | ATCC 25922 | NO | YES |
| Escherichia coli 0157:H7 | ATCC 700728 | YES | YES |
| Salmonella typhimurium | ATCC 14028 | YES | YES |
| Shigella sonnei | ATCC 12022 | NO | YES |
| Vibrio parahaemolyticus | ATCC 17802 | YES | YES |
| Yersinia enterocolitica | ATCC 9610 | NO | YES |

* 'NO' indicates that strain was not tested in the column heading matrix; 'YES' indicates that the strain was tested in the column heading matrix.

Roll-Plate Method:

Bacterial suspensions were prepared from fresh 18-24 hour cultures of each microorganism in a separate vial containing 10 mL of 0.85% sterile saline to obtain 1.5 x 10⁸ CFU/mL suspensions. A select group of organisms were also tested in a separate vial

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containing 10 mL fecal matrix. One log₁₀ serial dilutions were made and 100 μL aliquots of dilutions were absorbed into the swabs and immediately placed into the Puritan Fecal Opti-Swab Collection and Transport System. For fecal specimens, the final dilution prior to swab inoculation was done with fecal matrix to maximize the amount of fecal material on the swab.

After incubation at each time point, the swabs were removed from the transport tubes and used to inoculate the entire surface of the appropriate agar plate. The plates were incubated in appropriate culture conditions for 24-48 hours or until countable colonies were visible. Manual colony counts were conducted for each time interval for each swab-organism combination. The dilution yielding colony counts within the countable tolerance zone (approximately between 25 and 250 colonies) was reported. Log₁₀ increases or decreases in survival are based on a comparison between time-zero and the last time point collected for each temperature.

## Swab Elution Method:

Bacterial suspensions were prepared from fresh 18-24 hour cultures of each microorganism in a separate vial containing 10 mL of fecal matrix or 0.85% sterile saline to obtain 1.5 × 10⁸ CFU/mL suspensions. The suspensions were diluted in 0.85% saline or fecal matrix solution to obtain working suspensions of 1.5 × 10⁷ CFU/mL, and then 100 μL aliquots of dilutions were absorbed into the swabs and immediately placed into the Puritan Fecal Opti-Swab Collection and Transport System medium. After incubation at each time point, the swabs were removed from the transport tubes and 100 μL of 1-log₁₀ serial dilutions were made in 0.85% saline. 100 μL of each dilution was plated on the appropriate agar plate for each temperature and time point. The plates were incubated in appropriate culture conditions for 24-48 hours or until countable colonies were visible. Manual colony counts were conducted for each time interval for each swab-organism combination. The dilution yielding zero-time colony counts approximately between 25 and 250 CFU was reported.

Results from the Roll Plate and Swab Elution experiments as determined at various storage times and temperature ranges are shown in Tables 2-9 below.

Acceptance criteria for recovery of microorganisms is defined as being within one log₁₀ increase or decrease from the starting titer at time zero. Manual colony counts were conducted for each of the time intervals for each microorganism held at each temperature.

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| Table 2. Recovery results for Puritan Fecal Opti-Swab Collection and Transport System from fecal matrix using Roll-Plate Method at 20-25°C | | | | | |
| --- | --- | --- | --- | --- | --- |
| Microorganism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFUs Recovered: Time 0 h | Average CFUs Recovered: Time 24 h | Average CFUs Recovered: Time 48 h |
| Escherichia coli 0157:H7 ATCC 700728 | Diluted 10^{-4} | Puritan - 151002 | 51 | 145 | 269 |
| | | Puritan - 151026 | 38 | 118 | 244 |
| | | Puritan - 151105 | 44 | 126 | 257 |
| Salmonella typhimurium ATCC 14028 | Diluted 10^{-4} | Puritan - 151002 | 63 | 148 | 355 |
| | | Puritan - 151026 | 57 | 139 | 337 |
| | | Puritan - 151105 | 45 | 123 | 314 |
| Vibrio parahaemolyticus ATCC 17802 | Diluted 10^{-4} | Puritan - 151002 | 80 | 258 | 195 |
| | | Puritan - 151026 | 57 | 234 | 152 |
| | | Puritan - 151105 | 65 | 243 | 208 |
| Table 3. Recovery results for Puritan Fecal Opti-Swab Collection and Transport System from fecal matrix using Roll-Plate Method at 2-8°C | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Microorganism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFUs Recovered: Time 0 h | Average CFUs Recovered: Time 24 h | Average CFUs Recovered: Time 48 h | Average CFUs Recovered: Time 72 h |
| Escherichia coli 0157:H7 ATCC 700728 | Diluted 10^{-4} | Puritan - 151002 | 51 | 44 | 29 | 23 |
| | | Puritan - 151026 | 38 | 31 | 25 | 16 |
| | | Puritan - 151105 | 44 | 36 | 26 | 14 |
| Salmonella typhimurium ATCC 14028 | Diluted 10^{-4} | Puritan - 151002 | 63 | 49 | 37 | 21 |
| | | Puritan - 151026 | 57 | 51 | 42 | 33 |
| | | Puritan - 151105 | 45 | 36 | 29 | 22 |
| Vibrio parahaemolyticus ATCC 17802 | Diluted 10^{-4} | Puritan - 151002 | 80 | 125 | 69 | 53 |
| | | Puritan - 151026 | 57 | 93 | 46 | 39 |
| | | Puritan - 151105 | 65 | 109 | 61 | 47 |

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| Table 4. Recovery results for Puritan Fecal Opti-Swab Collection and Transport System from fecal matrix using Swab-Elution Method at 20-25°C | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Microorganism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFU/ml Recovered: Time 0 h | Average CFU/ml Recovered: Time 24 h | Average CFU/ml Recovered: Time 48 h | Growth/Death: Log10(48h/0h) |
| Escherichia coli 0157:H7 ATCC 700728 | 1:10 | Puritan - 151002 | 4.7 x 105 | 1.21 x 106 | 2.48 x 106 | 0.72 |
| | | Puritan - 151026 | 3.2 x 105 | 1.06 x 106 | 2.16x 106 | 0.83 |
| | | Puritan - 151105 | 3.9 x 105 | 1.17 x 106 | 2.22 x 106 | 0.76 |
| Salmonella typhimurium ATCC 14028 | 1:10 | Puritan - 151002 | 2.9 x 105 | 8.4 x 106 | 1.51 x 106 | 0.72 |
| | | Puritan - 151026 | 7.1 x 105 | 1.41x 106 | 3.14 x 106 | 0.65 |
| | | Puritan - 151105 | 6.7 x 105 | 1.46 x 106 | 3.29 x 106 | 0.69 |
| Vibrio parahaemolyticus ATCC 17802 | 1:10 | Puritan - 151002 | 5.8 x 105 | 1.37 x 106 | 3.12 x 106 | 0.73 |
| | | Puritan - 151026 | 5.4 x 105 | 1.28 x 106 | 2.46 x 106 | 0.66 |
| | | Puritan - 151105 | 4.9 x 105 | 1.14 x 106 | 2.59 x 106 | 0.72 |
| Table 5. Recovery results for Puritan Fecal Opti-Swab Collection and Transport System from fecal matrix using Swab-Elution Method at 2-8°C | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Microorganism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFU/ml Recovered: Time 0 h | Average CFU/ml Recovered: Time 24 h | Average CFU/ml Recovered: Time 48 h | Average CFU/ml Recovered: Time 72 h | Growth/Death: Log10(72h/0h) |
| Escherichia coli 0157:H7 ATCC 700728 | 1:10 | Puritan - 151002 | 4.7 x 105 | 4.0 x 105 | 3.1 x 105 | 1.9 x 105 | -0.39 |
| | | Puritan - 151026 | 3.2 x 105 | 2.7 x 105 | 2.0 x 105 | 1.5 x 105 | -0.33 |
| | | Puritan - 151105 | 3.9 x 105 | 3.2 x 105 | 2.5 x 105 | 1.4 x 105 | -0.44 |
| Salmonella typhimurium ATCC 14028 | 1:10 | Puritan - 151002 | 2.9 x 105 | 1.8 x 105 | 1.1 x 105 | 8.0 x 104 | -0.56 |
| | | Puritan - 151026 | 7.1 x 105 | 6.3 x 105 | 4.8 x 105 | 3.6 x 105 | -0.29 |
| | | Puritan - 151105 | 6.7 x 105 | 5.7 x 105 | 4.1x 105 | 2.9 x 105 | -0.36 |
| Vibrio parahaemolyticus ATCC 17802 | 1:10 | Puritan - 151002 | 5.8 x 105 | 4.8 x 105 | 3.9 x 105 | 3.1 x 105 | -0.27 |
| | | Puritan - 151026 | 5.4 x 105 | 4.5 x 105 | 3.2 x 105 | 2.4 x 105 | -0.35 |
| | | Puritan - 151105 | 4.9 x 105 | 3.8 x 105 | 3.0 x 105 | 2.4 x 105 | -0.31 |

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| Table 6. Recovery results for Puritan Fecal Opti-Swab Collection and Transport System from saline using Roll-Plate Method at 20-25°C | | | | | |
| --- | --- | --- | --- | --- | --- |
| Microorganism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFUs Recovered: Time 0 h | Average CFUs Recovered: Time 24 h | Average CFUs Recovered: Time 48 h |
| Campylobacter jejuni ATCC 33291 | Diluted 10-4 | Puritan - 160311 | 238 | 165 | 31 |
| | | Puritan - 160315 | 246 | 172 | 27 |
| | | Puritan - 160322 | 231 | 158 | 23 |
| Clostridium difficile ATCC 9689 | Diluted 10-4 | Puritan - 160311 | 88 | 18 | 18 |
| | | Puritan - 160315 | 62 | 13 | |
| | | Puritan - 160322 | 57 | 11 | |
| Enterococcus faecalis, Vancomycin-resistant (VRE) ATCC 51299 | Diluted 10-4 | Puritan - 160311 | 32 | 89 | 156 |
| | | Puritan - 160315 | 45 | 98 | 153 |
| | | Puritan - 160322 | 37 | 91 | 149 |
| Escherichia coli ATCC 25922 | Diluted 10-4 | Puritan - 160311 | 52 | 164 | 299 |
| | | Puritan - 160315 | 38 | 157 | 282 |
| | | Puritan - 160322 | 44 | 142 | 278 |
| Escherichia coli 0157:H7 ATCC 700728 | Diluted 10-4 | Puritan - 160311 | 56 | 137 | 254 |
| | | Puritan - 160315 | 43 | 123 | 209 |
| | | Puritan - 160322 | 34 | 116 | 196 |
| Salmonella typhimurium ATCC 14028 | Diluted 10-4 | Puritan - 160311 | 55 | 176 | 326 |
| | | Puritan - 160315 | 42 | 157 | 299 |
| | | Puritan - 160322 | 47 | 168 | 285 |
| Shigella sonnei ATCC 12022 | Diluted 10-4 | Puritan - 160311 | 40 | 153 | 275 |
| | | Puritan - 160315 | 56 | 269 | 314 |
| | | Puritan - 160322 | 30 | 146 | 251 |
| Vibrio parahaemolyticus ATCC 17802 | Diluted 10-4 | Puritan - 160311 | 80 | 236 | 328 |
| | | Puritan - 160315 | 73 | 224 | 316 |
| | | Puritan - 160322 | 67 | 215 | 311 |
| Yersinia enterocolitica ATCC 9610 | Diluted 10-4 | Puritan - 160311 | 58 | 216 | 315 |
| | | Puritan - 160315 | 65 | 228 | 356 |
| | | Puritan - 160322 | 51 | 209 | 318 |

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| Table 7. Recovery results for Puritan Fecal Opti-Swab Collection and Transport System from saline using Roll-Plate Method at 2-8°C | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Microorganism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFUs Recovered: Time 0 h | Average CFUs Recovered: Time 24 h | Average CFUs Recovered: Time 48 h | Average CFUs Recovered: Time 72 h |
| Campylobacter jejuni ATCC 33291 | Diluted 10-4 | Puritan - 160311 | 238 | 196 | 167 | 149 |
| | | Puritan - 160315 | 246 | 202 | 180 | 163 |
| | | Puritan - 160322 | 231 | 187 | 172 | 145 |
| Clostridium difficile ATCC 9689 | Diluted 10-4 | Puritan - 160311 | 88 | 31 | 12 | |
| | | Puritan - 160315 | 62 | 26 | 9 | |
| | | Puritan - 160322 | 57 | 21 | 5 | |
| Enterococcus faecalis, Vancomycin-resistant (VRE) ATCC 51299 | Diluted 10-4 | Puritan - 160311 | 32 | 25 | 19 | 14 |
| | | Puritan - 160315 | 45 | 39 | 27 | 20 |
| | | Puritan - 160322 | 37 | 29 | 23 | 18 |
| Escherichia coli ATCC 25922 | Diluted 10-4 | Puritan - 160311 | 52 | 48 | 31 | 19 |
| | | Puritan - 160315 | 38 | 32 | 25 | 16 |
| | | Puritan - 160322 | 44 | 36 | 29 | 17 |
| Escherichia coli 0157:H7 ATCC 700728 | Diluted 10-4 | Puritan - 160311 | 56 | 47 | 34 | 26 |
| | | Puritan - 160315 | 43 | 38 | 31 | 23 |
| | | Puritan - 160322 | 34 | 29 | 24 | 19 |
| Salmonella typhimurium ATCC 14028 | Diluted 10-4 | Puritan - 160311 | 55 | 71 | 48 | 43 |
| | | Puritan - 160315 | 42 | 57 | 36 | 29 |
| | | Puritan - 160322 | 47 | 62 | 44 | 37 |
| Shigella sonnei ATCC 12022 | Diluted 10-4 | Puritan - 160311 | 40 | 34 | 28 | 22 |
| | | Puritan - 160315 | 56 | 47 | 42 | 33 |
| | | Puritan - 160322 | 30 | 23 | 19 | 14 |
| Vibrio parahaemolyticus ATCC 17802 | Diluted 10-4 | Puritan - 160311 | 80 | 92 | 65 | 42 |
| | | Puritan - 160315 | 73 | 85 | 57 | 45 |
| | | Puritan - 160322 | 67 | 78 | 49 | 38 |
| Yersinia enterocolitica ATCC 9610 | Diluted 10-4 | Puritan - 160311 | 58 | 74 | 50 | 43 |
| | | Puritan - 160315 | 65 | 86 | 53 | 47 |
| | | Puritan - 160322 | 51 | 68 | 38 | 31 |

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| Table 8. Recovery results for Puritan Fecal Opti-Swab Collection and Transport System from saline using Swab Elution Method at 20-25°C | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Microorganism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFU/ml Recovered: Time 0 h | Average CFU/ml Recovered: Time 24 h | Average CFU/ml Recovered: Time 48 h | Growth/ Death: Log10(48h/0h) |
| Campylobacter jejuni ATCC 33291 | 1:10 | Puritan - 160311 | 2.09 X 10^6 | 1.57 x 10^6 | 2.1 x 10^5 | -1.00 |
| | | Puritan - 160315 | 2.24 X 10^6 | 1.64 x 10^6 | 2.4 x 10^5 | -0.97 |
| | | Puritan - 160322 | 2.15 x 10^6 | 1.43 x 10^6 | 2.6 x 10^5 | -0.92 |
| Clostridium difficile ATCC 9689 | 1:10 | Puritan - 160311 | 9.7 x 10^5 | 1.1 x 10^5 | | -0.95 |
| | | Puritan - 160315 | 7.4 x 10^5 | 6.0 x 10^4 | | -1.09 |
| | | Puritan - 160322 | 6.6 x 10^5 | 8.0 x 10^4 | | -0.92 |
| Enterococcus faecalis, Vancomycin-resistant (VRE) ATCC 51299 | 1:10 | Puritan - 160311 | 3.7 x 10^5 | 9.5 x 10^5 | 1.55 x 10^6 | 0.62 |
| | | Puritan - 160315 | 4.0 x 10^5 | 1.14 x 10^6 | 1.78 x 10^6 | 0.65 |
| | | Puritan - 160322 | 3.3 x 10^5 | 1.01 x 10^6 | 1.69 x 10^6 | 0.71 |
| Escherichia coli ATCC 25922 | 1:10 | Puritan - 160311 | 4.1 x 10^5 | 1.58 x 10^6 | 2.73 x 10^6 | 0.82 |
| | | Puritan - 160315 | 3.3 x 10^5 | 1.51 x 10^6 | 2.65 x 10^6 | 0.90 |
| | | Puritan - 160322 | 3.8 x 10^5 | 1.37 x 10^6 | 2.48 x 10^6 | 0.81 |
| Escherichia coli 0157:H7 ATCC 700728 | 1:10 | Puritan - 160311 | 4.6 x 10^5 | 1.53 x 10^6 | 2.39 x 10^6 | 0.72 |
| | | Puritan - 160315 | 3.8 x 10^5 | 1.45 x 10^6 | 1.95 x 10^6 | 0.71 |
| | | Puritan - 160322 | 3.4 x 10^5 | 1.30 x 10^6 | 2.18 x 10^6 | 0.81 |
| Salmonella typhimurium ATCC 14028 | 1:10 | Puritan - 160311 | 4.5 x 10^5 | 1.96 x 10^6 | 3.25 x 10^6 | 0.86 |
| | | Puritan - 160315 | 3.6 x 10^5 | 1.83 x 10^6 | 2.99 x 10^6 | 0.92 |
| | | Puritan - 160322 | 4.1 x 10^5 | 1.71 x 10^6 | 3.06 x 10^6 | 0.87 |
| Shigella sonnei ATCC 12022 | 1:10 | Puritan - 160311 | 3.4 x 10^5 | 1.42 x 10^6 | 2.56 x 10^6 | 0.88 |
| | | Puritan - 160315 | 4.2 x 10^5 | 1.57 x 10^6 | 2.79 x 10^6 | 0.82 |
| | | Puritan - 160322 | 2.9 x 10^5 | 1.39 x 10^6 | 2.38 x 10^6 | 0.91 |
| Vibrio parahaemolyticus ATCC 17802 | 1:10 | Puritan - 160311 | 5.7 x 10^5 | 2.61 x 10^6 | 3.57 x 10^6 | 0.80 |
| | | Puritan - 160315 | 4.8 x 10^5 | 2.53 x 10^6 | 3.72 x 10^6 | 0.89 |
| | | Puritan - 160322 | 3.6 x 10^5 | 2.28 x 10^6 | 3.02 x 10^6 | 0.92 |
| Yersinia enterocolitica ATCC 9610 | 1:10 | Puritan - 160311 | 4.9 x 105 | 2.21 x 10^6 | 3.27 x 10^6 | 0.82 |
| | | Puritan - 160315 | 5.0 x 10^5 | 2.39 x 10^6 | 3.56 x 10^6 | 0.85 |
| | | Puritan - 160322 | 3.5 x 10^5 | 2.16 x 10^6 | 3.02 x 10^6 | 0.94 |

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| Table 9. Recovery results for Puritan Fecal Opti-Swab Collection and Transport System from saline using Swab Elution Method at 2-8°C | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Microorganism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFU/ml Recovered: Time 0 h | Average CFU/ml Recovered: Time 24 h | Average CFU/ml Recovered: Time 48 h | Average CFU/ml Recovered: Time 72 h | Growth/ Death: Log10(72h/0h) |
| Campylobacter jejuni ATCC 33291 | 1:10 | Puritan - 160311 | 2.09 x 106 | 1.76 x 106 | 1.52 x 106 | 1.37 x 106 | -0.18 |
| | | Puritan - 160315 | 2.24 x 106 | 1.91 x 106 | 1.75 x 106 | 1.54 x 106 | -0.16 |
| | | Puritan - 160322 | 2.15 x 106 | 1.83 x 106 | 1.67 x 106 | 1.45 x 106 | -0.17 |
| Clostridium difficile ATCC 9689 | 1:10 | Puritan - 160311 | 9.7 x 105 | 2.8 x 105 | 1.0 x 105 | | -0.99 |
| | | Puritan - 160315 | 7.4 x 105 | 2.3 x 105 | 7.0 x 104 | | -1.02 |
| | | Puritan - 160322 | 6.6 x 105 | 1.7 x 105 | 5.0 x 104 | | -1.12 |
| Enterococcus faecalis, Vancomycin-resistant (VRE) ATCC 51299 | 1:10 | Puritan - 160311 | 3.7 x 105 | 3.0 x 105 | 2.2 x 105 | 1.4 x 105 | -0.42 |
| | | Puritan - 160315 | 4.0 x 105 | 2.9 x 105 | 2.0 x 105 | 1.2 x 105 | -0.52 |
| | | Puritan - 160322 | 3.3 x 105 | 2.7 x 105 | 1.9 x 105 | 1.1 x 105 | -0.48 |
| Escherichia coli ATCC 25922 | 1:10 | Puritan - 160311 | 4.1 x 105 | 3.4 x 105 | 1.6 x 105 | 1.1 x 105 | -0.57 |
| | | Puritan - 160315 | 3.3 x 105 | 2.5 x 105 | 1.8 x 105 | 1.3 x 105 | -0.40 |
| | | Puritan - 160322 | 3.8 x 105 | 3.1 x 105 | 2.1 x 105 | 1.7 x 105 | -0.35 |
| Escherichia coli 0157:H7 ATCC 700728 | 1:10 | Puritan - 160311 | 4.6 x 105 | 3.9 x 105 | 2.7 x 105 | 1.9 x 105 | -0.38 |
| | | Puritan - 160315 | 3.8 x 105 | 3.1 x 105 | 2.4 x 105 | 1.7 x 105 | -0.35 |
| | | Puritan - 160322 | 3.4 x 105 | 2.6 x 105 | 1.9 x 105 | 1.2 x 105 | -0.45 |
| Salmonella typhimurium ATCC 14028 | 1:10 | Puritan - 160311 | 4.5 x 105 | 3.8 x 105 | 2.6 x 105 | 1.8 x 105 | -0.40 |
| | | Puritan - 160315 | 3.6 x 105 | 3.2 x 105 | 2.3 x 105 | 1.6 x 105 | -0.35 |
| | | Puritan - 160322 | 4.1 x 105 | 3.4 x 105 | 2.8 x 105 | 2.0 x 105 | -0.31 |
| Shigella sonnei ATCC 12022 | 1:10 | Puritan - 160311 | 3.4 x 105 | 2.6 x 105 | 1.8 x 105 | 1.2 x 105 | -0.45 |
| | | Puritan - 160315 | 4.2 x 105 | 3.7 x 105 | 2.9 x 105 | 2.1 x 105 | -0.30 |
| | | Puritan - 160322 | 2.9 x 105 | 2.3 x 105 | 1.7 x 105 | 1.0 x 105 | -0.46 |
| Vibrio parahaemolyticus ATCC 17802 | 1:10 | Puritan - 160311 | 5.7 x 105 | 7.2 x 105 | 4.5 x 105 | 3.8 x 105 | -0.18 |
| | | Puritan - 160315 | 4.8 x 105 | 6.6 x 105 | 4.1 x 105 | 3.3 x 105 | -0.16 |
| | | Puritan - 160322 | 3.6 x 105 | 5.2 x 105 | 3.2 x 105 | 2.7 x 105 | -0.12 |
| Yersinia enterocolitica ATCC 9610 | 1:10 | Puritan - 160311 | 4.9 x 105 | 6.4 x 105 | 3.8 x 105 | 2.5 x 105 | -0.29 |
| | | Puritan - 160315 | 5.0 x 105 | 6.7 x 105 | 4.3 x 105 | 3.3 x 105 | -0.18 |
| | | Puritan - 160322 | 3.5 x 105 | 5.2 x 105 | 3.1 x 105 | 2.0 x 105 | -0.24 |

These results demonstrate that the pre-defined acceptance criteria were met for each bacterial strain tested by both the Roll-Plate and Swab Elution Methods. Those results are described in labeling.

a. Precision/Reproducibility:

{12}

Not applicable.

b. Linearity/assay reportable range:
Not applicable.

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

Shelf-life Stability: Shelf life stability test were performed successfully on three lots of product demonstrating stability for up to 15 months at room temperature. Recovery of microorganisms from fecal matrix was assessed by the Roll Plate method, as described in M.1 above.

pH Stability: The pH of the test device was measured at predetermined time intervals up to 20 months after manufacturing date. The test was performed using calibrated pH meter with random samples from three different lots of Puritan Fecal Opti-Swab Collection and Transport System. All samples tested were found to maintain pH within the specified range of pH 6.90 to 7.50.

Cytotoxicity: Cytotoxicity test was conducted to evaluate glue, shaft and the rayon tipped swabs for potential cytotoxicity effect following ISO Elution Method-1X MEM Extract. No evidence of cytotoxicity was detected.

Sterilization: Puritan Fecal Opti-Swab Collection and Transport System are sterilized by gamma irradiation and validated following ANSI/AAMI/ISO 11137:2006, Sterilization of health care products Radiation guidelines.

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:
Not applicable.

b. Matrix comparison:

{13}

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.

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
Not applicable.

N. Proposed Labeling:
The labeling is sufficient and it 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.

14