Puritan Opti-Tranz Cary-Blair Collection and Transport System

K160082 · Puritan Medical Products, LLC · JSM · Jul 29, 2016 · Microbiology

Device Facts

• Record ID: K160082
• Device Name: Puritan Opti-Tranz Cary-Blair Collection and Transport System
• Applicant: Puritan Medical Products, LLC
• Product Code: JSM · Microbiology
• Decision Date: Jul 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2390
• Device Class: Class 1

Indications for Use

The Puritan Opti-Tranz Cary-Blair 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

System consists of sterile peel pouch containing rayon-tipped swab applicator and polypropylene tube with 5 ml Cary-Blair medium. Medium is nonnutritive balanced salt solution (disodium phosphate, sodium chloride, calcium chloride, agar, sodium thioglycollate) providing reduced environment and osmotic balance. Used at collection site by healthcare personnel to collect fecal/rectal specimens; specimens transported to laboratory. Device maintains viability of enteric bacteria during transit. Healthcare providers use recovered samples for standard bacteriological examination and culture. Benefits include preservation of specimen integrity for accurate diagnostic testing.

Clinical Evidence

Bench testing only. Performance evaluated per CLSI M40-A2 using quantitative colony enumeration (Roll-Plate and Swab Elution methods). Eight ATCC enteric bacterial strains tested in fecal matrix and saline. Results demonstrated viability maintenance within 2 log10 increase/decrease from time zero for 48 hours at 20-25°C and 72 hours at 2-8°C. Cytotoxicity testing (ISO Elution Method) showed no evidence of cytotoxicity.

Technological Characteristics

Materials: Rayon-tipped swab, polypropylene tube. Medium: Semi-solid Cary-Blair (sodium chloride, disodium phosphate, sodium thioglycollate, calcium chloride, bacteriological agar). Sterilization: Gamma irradiation per ANSI/AAMI/ISO 11137:2006. Single-use, non-nutritive transport system.

Indications for Use

Indicated for the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria for laboratory 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 Venturi Transystem Cary-Blair Medium product (132C) (k946286)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
K160082

B. Purpose for Submission:
To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair 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® Opti-Tranz™ Cary-Blair 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

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JTW: System, Transport, Aerobic

4. Panel:
83- Microbiology

H. Intended Use:

1. Intended use(s):
The Puritan Opti-Tranz Cary-Blair 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® Opti-Tranz™ Cary-Blair 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 5 ml of a semi-solid 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 a solidifying agent and gives a semisolid texture to the medium. Sodium thioglycollate helps maintain an oxygen-reduced environment to help maintain the viability of enteric bacteria during the transport to the laboratory.

The semi-solid Cary Blair medium is composed of the following components:
- Sodium chloride 5.0 g/L
- Disodium Phosphate, 1.1 g/L

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- Sodium thioglycollate 1.5 g/L
- Calcium chloride, 0.09 g/L
- Bacteriological agar, 5.6 g/L
- Deionized water 1 L

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Copan Venturi Transystem Cary-Blair Medium product (132C)

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

k946286

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System (k160082) | Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) |
| Intended Use | The Puritan Opti-Tranz Cary-Blair 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. | 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 |
| | Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System (k160082) | Copan Venturi Transystem Cary-Blair Medium product (132C) (k946286) |
| Specimen Storage | Up to 48 h at 20 – 25 °C and up to 72 h at refrigerated conditions 2 – 8 °C | Same |
| Tube | Polypropylene, round bottom | Same |
| Medium Volume | 5 mL | Same |
| Single Use Device | Yes | Same |
| Packaging | Peel pouch | Same |
| Swab | Rayon | Same |
| Medium Formulation | Sodium chloride 5.0 g/L
Disodium Phosphate, 1.1 g/L
Sodium thioglycollate 1.5 g/L
Calcium chloride, 0.09 g/L
Bacteriological agar, 5.6 g/L
Deionized water 1 L | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Organisms Tested | Campylobacter jejuni
Enterococcus faecalis
Escherichia coli
Salmonella typhimurium
Shigella sonnei
Vibrio parahaemolyticus
Yersinia enterocolitica | Campylobacter jejuni
Escherichia coli
Shigella flexneri
Yersinia enterocolitica |
| pH | 6.9 – 7.5 | 8.4 ± 0.2 |
| Shelf life | 20 months | 24 months |

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.

M. Performance Characteristics (if/when applicable):

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1. Analytical performance:

Analytical studies were conducted to determine the ability of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System to maintain the viability of enteric microorganisms.

The performance of the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System was determined using quantitative colony enumeration 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 100 μL of select bacterial concentrations prepared in a fecal matrix and/or 0.85% phosphate buffered saline (PBS). To facilitate testing, a homogeneous fecal matrix was prepared by diluting pre-screened negative fresh clinical fecal material in 0.85% PBS to a 30% concentration by volume.

Once inoculated, the 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 eight ATCC strains listed in Table 1 below were used to evaluate the performance of the Puritan Opti-Tranz Cary-Blair 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.

| Table 1: Enteric bacteria evaluated for stability in Puritan Opti-Tranz Cary-Blair Collection and Transport System | | | |
| --- | --- | --- | --- |
| Microorganism | ATCC # | Fecal Matrix* | 0.85% Saline* |
| Campylobacter jejuni | ATCC 33291 | 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 |
| Vancomycin-resistant Enterococcus faecalis (VRE) | ATCC 51299 | NO | 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 fecal matrix or 0.85% sterile saline to obtain 1.5 × 10⁸ CFU/mL suspensions. One log₁₀ serial dilutions were made and 100 μL aliquots of dilutions were absorbed into the swabs and immediately placed into the

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Puritan Opti-Tranz Cary-Blair medium. 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 nearest to zero (not to exceed 250 CFU) was reported. $\mathrm{Log_{10}}$ 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 $10~\mathrm{mL}$ of fecal matrix or $0.85\%$ sterile saline to obtain $1.5 \times 10^{8} \mathrm{CFU/mL}$ suspensions. The suspensions were diluted in $0.85\%$ saline or fecal matrix solution to obtain working suspensions of $1.5 \times 10^{7} \mathrm{CFU/mL}$, and then $100~\mu\mathrm{L}$ aliquots of dilutions were absorbed into the swabs and immediately placed into the Puritan Opti-Tranz Cary-Blair medium. After incubation at each time point, the swabs were removed from the transport tubes and $100~\mu\mathrm{L}$ of $1-\log_{10}$ serial dilutions were made in $0.85\%$ saline. $100~\mu\mathrm{L}$ 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 between 25 and 250 CFU was reported.

Recovery results from Roll Plate and Swab Elution experiments are shown in Tables 2-9 below for various strains and product lot numbers tested at the storage times, specimen matrix and temperature ranges indicated.

| Temperature Range | Plating Method | Fecal Matrix | Saline |
| --- | --- | --- | --- |
| 20-25 °C | Roll Plate | Table 2 | Table 6 |
| 2-8 °C | Swab Elution | Table 3 | Table 7 |
| 20-25 °C | Roll Plate | Table 4 | Table 8 |
| 2-8 °C | Swab Elution | Table 5 | Table 9 |

Acceptance criteria for recovery of microorganisms were as recommended in the CLSI document M40-A2 and defined as being within two $\log_{10}$ 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. The results from these studies demonstrated that the Puritan Opti-Tranz Cary-Blair Collection and Transport System can support the viability enteric bacteria for up to 48 hours at $20 - 25^{\circ}\mathrm{C}$ and 72 hours at $2 - 8^{\circ}\mathrm{C}$.

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| Table 2. Recovery results for Puritan Opti-Tranz Cary-Blair 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 | 94 | 202 | 266 |
| | | Puritan - 151026 | 79 | 181 | 262 |
| | | Puritan - 151105 | 83 | 190 | 279 |
| Salmonella typhimurium ATCC 14028 | Diluted 10^{-4} | Puritan - 151002 | 89 | 157 | 359 |
| | | Puritan - 151026 | 72 | 141 | 326 |
| | | Puritan - 151105 | 67 | 123 | 338 |
| Vibrio parahaemolyticus ATCC 17802 | Diluted 10^{-4} | Puritan - 151002 | 99 | 266 | 163 |
| | | Puritan - 151026 | 86 | 234 | 150 |
| | | Puritan - 151105 | 73 | 251 | 153 |
| Table 3. Recovery results for Puritan Opti-Tranz Cary-Blair 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 | 94 | 73 | 58 | 53 |
| | | Puritan - 151026 | 79 | 72 | 64 | 56 |
| | | Puritan - 151105 | 83 | 76 | 70 | 62 |
| Salmonella typhimurium ATCC 14028 | Diluted 10^{-4} | Puritan - 151002 | 89 | 97 | 88 | 123 |
| | | Puritan - 151026 | 72 | 85 | 87 | 93 |
| | | Puritan - 151105 | 67 | 76 | 82 | 111 |
| Vibrio parahaemolyticus ATCC 17802 | Diluted 10^{-4} | Puritan - 151002 | 99 | 52 | 27 | 31 |
| | | Puritan - 151026 | 86 | 59 | 38 | 24 |
| | | Puritan - 151105 | 73 | 40 | 25 | 19 |

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| Table 4. Recovery results for Puritan Opti-Tranz Cary-Blair 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 | Log10 Change (48h/0h) |
| Escherichia coli 0157:H7 ATCC 700728 | 1:10 | Puritan - 151002 | 8.3 x 10^{5} | 1.86 x 10^{6} | 2.62 x 10^{6} | 0.50 |
| | | Puritan - 151026 | 6.8 x 10^{5} | 1.59 x 10^{6} | 2.52 x 10^{6} | 0.57 |
| | | Puritan - 151105 | 7.5 x 10^{5} | 1.61 x 10^{6} | 2.46 x 10^{6} | 0.52 |
| Salmonella typhimurium ATCC 14028 | 1:10 | Puritan - 151002 | 7.6 x 10^{5} | 1.35 x 10^{6} | 3.18 x 10^{6} | 0.62 |
| | | Puritan - 151026 | 5.7 x 10^{5} | 1.21 x 10^{6} | 3.12 x 10^{6} | 0.74 |
| | | Puritan - 151105 | 6.8 x 10^{5} | 1.4 x 10^{6} | 3.05 x 10^{6} | 0.65 |
| Vibrio parahaemolyticus ATCC 17802 | 1:10 | Puritan - 151002 | 8.4 x 10^{5} | 2.43 x 10^{6} | 2.12 x 10^{6} | 0.40 |
| | | Puritan - 151026 | 7.1 x 10^{5} | 2.65 x 10^{6} | 2.26 x 10^{6} | 0.50 |
| | | Puritan - 151105 | 6.6 x 10^{5} | 2.31 x 10^{6} | 1.85 x 10^{6} | 0.45 |
| Table 5. Recovery results for Puritan Opti-Tranz Cary-Blair 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 | Log10 Change (72h/0h) |
| Escherichia coli 0157:H7 ATCC 700728 | 1:10 | Puritan - 151002 | 8.3 x 10^{5} | 6.7 x 10^{5} | 5.1 x 10^{5} | 4.6 x 10^{5} | -0.26 |
| | | Puritan - 151026 | 6.8 x 10^{5} | 6.2 x 10^{5} | 5.4 x 10^{5} | 4.7 x 10^{5} | -0.16 |
| | | Puritan - 151105 | 7.5 x 10^{5} | 5.8 x 10^{5} | 4.9 x 10^{5} | 3.9 x 10^{5} | -0.28 |
| Salmonella typhimurium ATCC 14028 | 1:10 | Puritan - 151002 | 7.6 x 10^{5} | 8.5 x 10^{5} | 9.2 x 10^{5} | 1.18 x 10^{6} | 0.19 |
| | | Puritan - 151026 | 5.7 x 10^{5} | 6.3 x 10^{5} | 7.5 x 10^{5} | 1.05 x 10^{5} | 0.27 |
| | | Puritan - 151105 | 6.8 x 10^{5} | 7.3 x 10^{5} | 8.7 x 10^{5} | 9.9 x 10^{5} | 0.16 |
| Vibrio parahaemolyticus ATCC 17802 | 1:10 | Puritan - 151002 | 8.4 x 10^{5} | 4.7 x 10^{5} | 2.9 x 10^{5} | 1.6 x 10^{5} | -0.72 |
| | | Puritan - 151026 | 7.1 x 10^{5} | 5.2 x 10^{5} | 3.4 x 10^{5} | 2.0 x 10^{5} | -0.55 |
| | | Puritan - 151105 | 6.6 x 10^{5} | 4.2 x 10^{5} | 3.1 x 10^{5} | 1.6 x 10^{5} | -0.62 |

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| Table 6. Recovery results for Puritan Opti-Tranz Cary-Blair 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 - 151002 | 195 | 132 | 15 |
| | | Puritan - 151026 | 241 | 193 | 37 |
| | | Puritan - 151105 | 243 | 181 | 23 |
| Escherichia coli ATCC 25922 | Diluted 10-4 | Puritan - 151002 | 32 | 168 | 270 |
| | | Puritan - 151026 | 57 | 185 | 320 |
| | | Puritan - 151105 | 44 | 159 | 284 |
| Escherichia coli 0157:H7 ATCC 700728 | Diluted 10-4 | Puritan - 151002 | 34 | 83 | 118 |
| | | Puritan - 151026 | 47 | 100 | 146 |
| | | Puritan - 151105 | 55 | 128 | 222 |
| Salmonella typhimurium ATCC 14028 | Diluted 10-4 | Puritan - 151002 | 31 | 103 | 182 |
| | | Puritan - 151026 | 43 | 117 | 196 |
| | | Puritan - 151105 | 55 | 152 | 269 |
| Shigella sonnei ATCC 12022 | Diluted 10-4 | Puritan - 151002 | 54 | 197 | 333 |
| | | Puritan - 151026 | 41 | 175 | 304 |
| | | Puritan - 151105 | 46 | 152 | 241 |
| Vibrio parahaemolyticus ATCC 17802 | Diluted 10-4 | Puritan - 151002 | 38 | 164 | 270 |
| | | Puritan - 151026 | 60 | 212 | 370 |
| | | Puritan - 151105 | 49 | 147 | 251 |
| Vancomycin-resistant Enterococcus faecalis (VRE) ATCC 51299 | Diluted 10-4 | Puritan - 151002 | 27 | 47 | 59 |
| | | Puritan - 151026 | 31 | 54 | 91 |
| | | Puritan - 151105 | 35 | 40 | 98 |
| Yersinia enterocolitica ATCC 9610 | Diluted 10-4 | Puritan - 151002 | 37 | 182 | 315 |
| | | Puritan - 151026 | 52 | 209 | 368 |
| | | Puritan - 151105 | 45 | 164 | 264 |

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| Table 7. Recovery results for Puritan Opti-Tranz Cary-Blair 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 - 151002 | 195 | 117 | 74 | 19 |
| | | Puritan - 151026 | 241 | 166 | 98 | 26 |
| | | Puritan - 151105 | 243 | 172 | 92 | 27 |
| Escherichia coli ATCC 25922 | Diluted 10-4 | Puritan - 151002 | 32 | 45 | 22 | 8 |
| | | Puritan - 151026 | 57 | 72 | 43 | 22 |
| | | Puritan - 151105 | 44 | 59 | 30 | 16 |
| Escherichia coli 0157:H7 ATCC 700728 | Diluted 10-4 | Puritan - 151002 | 34 | 25 | 17 | 9 |
| | | Puritan - 151026 | 47 | 37 | 22 | 11 |
| | | Puritan - 151105 | 55 | 53 | 29 | 15 |
| Salmonella typhimurium ATCC 14028 | Diluted 10-4 | Puritan - 151002 | 31 | 56 | 34 | 20 |
| | | Puritan - 151026 | 43 | 67 | 40 | 29 |
| | | Puritan - 151105 | 55 | 72 | 49 | 39 |
| Shigella sonnei ATCC 12022 | Diluted 10-4 | Puritan - 151002 | 54 | 69 | 43 | 32 |
| | | Puritan - 151026 | 41 | 71 | 39 | 28 |
| | | Puritan - 151105 | 46 | 82 | 42 | 39 |
| Vibrio parahaemolyticus ATCC 17802 | Diluted 10-4 | Puritan - 151002 | 38 | 62 | 44 | 27 |
| | | Puritan - 151026 | 60 | 77 | 58 | 41 |
| | | Puritan - 151105 | 49 | 66 | 45 | 34 |
| Vancomycin-resistant Enterococcus faecalis (VRE) ATCC 51299 | Diluted 10-4 | Puritan - 151002 | 27 | 21 | 17 | 12 |
| | | Puritan - 151026 | 31 | 24 | 19 | 13 |
| | | Puritan - 151105 | 35 | 22 | 18 | 16 |
| Yersinia enterocolitica ATCC 9610 | Diluted 10-4 | Puritan - 151002 | 37 | 61 | 42 | 28 |
| | | Puritan - 151026 | 52 | 78 | 56 | 43 |
| | | Puritan - 151105 | 45 | 73 | 51 | 41 |

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| Table 8. Recovery results for Puritan Opti-Tranz Cary-Blair 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 | Log10Change(48h/0h) |
| Campylobacter jejuniATCC 33291 | 1:10 | Puritan - 151002 | 1.99 X 10^6 | 1.29 X 10^6 | 1.0 X 10^5 | -1.30 |
| | | Puritan - 151026 | 2.48 X 10^6 | 1.83 X 10^6 | 1.8 X 10^5 | -1.14 |
| | | Puritan - 151105 | 2.5 X 10^6 | 1.72 X 10^6 | 1.4 X 10^5 | -1.25 |
| Escherichia coliATCC 25922 | 1:10 | Puritan - 151002 | 4.1 X 10^5 | 1.54 X 10^6 | 2.59 X 10^6 | 0.80 |
| | | Puritan - 151026 | 6.2 X 10^5 | 1.72 X 10^6 | 3.0 X 10^6 | 0.68 |
| | | Puritan - 151105 | 5.1 X 10^5 | 1.47 X 10^6 | 2.66 X 10^6 | 0.72 |
| Escherichia coli0157:H7ATCC 700728 | 1:10 | Puritan - 151002 | 3.3 X 10^5 | 7.6 X 10^5 | 1.11 X 10^6 | 0.53 |
| | | Puritan - 151026 | 4.7 X 10^5 | 9.4 X 10^5 | 1.34 X 10^6 | 0.46 |
| | | Puritan - 151105 | 5.5 X 10^5 | 1.19 X 10^6 | 2.14 X 10^6 | 0.59 |
| Salmonella typhimuriumATCC 14028 | 1:10 | Puritan - 151002 | 3.9 X 10^5 | 9.6 X 10^5 | 1.75 X 10^6 | 0.65 |
| | | Puritan - 151026 | 4.8 X 10^5 | 1.05 X 10^6 | 1.84 X 10^6 | 0.58 |
| | | Puritan - 151105 | 6.0 X 10^5 | 1.49 X 10^6 | 2.61 X 10^6 | 0.64 |
| Shigella sonneiATCC 12022 | 1:10 | Puritan - 151002 | 6.0 X 10^5 | 1.81 X 10^6 | 1.16 X 10^6 | 0.72 |
| | | Puritan - 151026 | 4.7 X 10^5 | 1.63 X 10^6 | 2.94 X 10^6 | 0.80 |
| | | Puritan - 151105 | 5.3 X 10^5 | 1.33 X 10^6 | 2.28 X 10^6 | 0.63 |
| Vibrio parahaemolyticusATCC 17802 | 1:10 | Puritan - 151002 | 4.6 X 10^5 | 1.51 X 10^6 | 2.59 X 10^6 | 0.75 |
| | | Puritan - 151026 | 6.9 X 10^5 | 1.98 X 10^6 | 3.04 X 10^6 | 0.64 |
| | | Puritan - 151105 | 5.7 X 10^5 | 1.32 X 10^6 | 2.44 X 10^6 | 0.63 |
| Vancomycin-resistantEnterococcus faecalis(VRE)ATCC 51299 | 1:10 | Puritan - 151002 | 3.3 X 10^5 | 4.4 X 10^5 | 5.4 X 10^5 | 0.21 |
| | | Puritan - 151026 | 3.7 X 10^5 | 4.8 X 10^5 | 8.9 X 10^5 | 0.38 |
| | | Puritan - 151105 | 4.0 X 10^5 | 4.2 X 10^5 | 9.0 X 10^5 | 0.35 |
| Yersinia enterocoliticaATCC 9610 | 1:10 | Puritan - 151002 | 4.3 X 10^5 | 1.74 X 10^6 | 2.99 X 10^6 | 0.84 |
| | | Puritan - 151026 | 5.7 X 10^5 | 1.98 X 10^6 | 3.24 X 10^6 | 0.75 |
| | | Puritan - 151105 | 4.9 X 10^5 | 1.57 X 10^6 | 2.55 X 10^6 | 0.72 |

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| Table 9. Recovery results for Puritan Opti-Tranz Cary-Blair 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 jejuniATCC 33291 | 1:10 | Puritan - 151002 | 1.99 X 10^6 | 1.14 X 10^6 | 6.5 X 10^5 | 1.1 X 10^5 | -1.26 |
| | | Puritan - 151026 | 2.48 X 10^6 | 1.52 X 10^6 | 9.4 X 10^5 | 2.1 X 10^5 | -1.07 |
| | | Puritan - 151105 | 2.5 X 10^6 | 1.59 X 10^6 | 8.6 X 10^5 | 1.9 X 10^5 | -1.12 |
| Escherichia coliATCC 25922 | 1:10 | Puritan - 151002 | 4.1 X 10^5 | 3.5 X 10^5 | 1.8 X 10^5 | 7.0 X 10 | -0.77 |
| | | Puritan - 151026 | 6.2 X 10^5 | 6.8 X 10^5 | 4.0 X 10^5 | 1.6 X 10^5 | -0.59 |
| | | Puritan - 151105 | 5.1 X 10^5 | 5.2 X 10^5 | 2.4 X 10^5 | 1.1 X 10^5 | -0.67 |
| Escherichia coli0157:H7ATCC 700728 | 1:10 | Puritan - 151002 | 3.3 X 10^5 | 1.2 X 10^5 | 8.0 X 10^4 | 3.5 X 10^4 | -0.97 |
| | | Puritan - 151026 | 4.7 X 10^5 | 3.4 X 10^5 | 1.9 X 10^5 | 4.0 X 10^4 | -1.07 |
| | | Puritan - 151105 | 5.5 X 10^5 | 4.8 X 10^5 | 2.2 X 10^5 | 5.0 X 10^4 | -1.04 |
| Salmonella typhimuriumATCC 14028 | 1:10 | Puritan - 151002 | 3.9 X 10^5 | 4.3 X 10^5 | 2.7 X 10^5 | 1.9 X 10^5 | -0.31 |
| | | Puritan - 151026 | 4.8 X 10^5 | 6.1 X 10^5 | 3.6 X 10^5 | 2.1 X 10^5 | -0.36 |
| | | Puritan - 151105 | 6.0 X 10^5 | 6.7 X 10^5 | 4.1 X 10^5 | 3.3 X 10^5 | -0.26 |
| Shigella sonneiATCC 12022 | 1:10 | Puritan - 151002 | 6.0 X 10^5 | 5.8 X 10^5 | 4.1 X 10^5 | 3.0 X 10^5 | -0.30 |
| | | Puritan - 151026 | 4.7 X 10^5 | 6.5 X 10^5 | 3.3 X 10^5 | 2.1 X 10^5 | -0.35 |
| | | Puritan - 151105 | 5.3 X 10^5 | 7.4 X 10^5 | 3.6 X 10^5 | 2.7 X 10^5 | -0.29 |
| Vibrio parahaemolyticusATCC 17802 | 1:10 | Puritan - 151002 | 4.6 X 10^5 | 5.8 X 10^5 | 3.7 X 10^5 | 2.0 X 10^5 | -0.36 |
| | | Puritan - 151026 | 6.9 X 10^5 | 7.2 X 10^5 | 5.4 X 10^5 | 3.7 X 10^5 | -0.27 |
| | | Puritan - 151105 | 5.7 X 10^5 | 6.0 X 10^5 | 4.0 X 10^5 | 2.8 X 10^5 | -0.31 |
| Vancomycin-resistantEnterococcus faecalis (VRE)ATCC 51299 | 1:10 | Puritan - 151002 | 3.3 X 10^5 | 1.6 X 10^5 | 1.3 X 10^5 | 9.0 X 10^4 | -0.56 |
| | | Puritan - 151026 | 3.7 X 10^5 | 1.9 X 10^5 | 1.2 X 10^5 | 6.0 X 10^4 | -0.79 |
| | | Puritan - 151105 | 4.0 X 10^5 | 2.0 X 10^5 | 1.5 X 10^5 | 1.2 X 10^5 | -0.52 |
| Yersinia enterocoliticaATCC 9610 | 1:10 | Puritan - 151002 | 4.3 X 10^5 | 5.4 X 10^5 | 3.8 X 10^5 | 2.3 X 10^5 | -0.27 |
| | | Puritan - 151026 | 5.7 X 10^5 | 7.1 X 10^5 | 4.7 X 10^5 | 3.5 X 10^5 | -0.21 |
| | | Puritan - 151105 | 4.9 X 10^5 | 6.7 X 10^5 | 4.2 X 10^5 | 3.4 X 10^5 | -0.16 |

a. Precision/Reproducibility:

Not applicable.

b. Linearity/assay reportable range:

Not applicable.

{12}

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

Shelf-life Stability: Shelf life stability tests were performed successfully on three lots of products stored for 20 months at room temperature. Recovery of microorganisms from fecal matrix was assessed by the Roll Plate method, as described in section M.1 above (see Table 10 below for results).

| Table 10. Roll plate recovery results for Puritan Opti-Tranz Cary-Blair Collection and Transport System stored for 20 months then inoculated with specified organism in fecal matrix and stored 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 | 86 | 183 | 260 |
| | | Puritan - 151026 | 91 | 198 | 257 |
| | | Puritan - 151105 | 77 | 186 | 249 |
| Salmonella typhimurium ATCC 14028 | Diluted 10-4 | Puritan - 151002 | 82 | 151 | 303 |
| | | Puritan - 151026 | 68 | 135 | 294 |
| | | Puritan - 151105 | 61 | 129 | 288 |
| Vibrio parahaemolyticus ATCC 17802 | Diluted 10-4 | Puritan - 151002 | 93 | 258 | 117 |
| | | Puritan - 151026 | 82 | 232 | 111 |
| | | Puritan - 151105 | 59 | 226 | 104 |

pH Stability: The pH of the test device was measured at predetermined time intervals for up to 20 months after manufacturing date. The test was performed using calibrated pH meter with random samples from three different lots of Puritan Opti-Tranz Cary-Blair 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 testing was conducted to evaluate the glue, shaft and rayon tipped swabs for potential cytotoxicity effects following ISO Elution Method-1X MEM Extract. No evidence of cytotoxicity was detected.

Sterilization: Puritan Opti-Tranz Cary-Blair 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:

{13}

Not applicable.

f. Assay cut-off:
Not applicable.

2. Comparison studies:
a. Method comparison with predicate device:
Not applicable.
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.

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