Puritan OptiTranz Liquid Stuart Collection and Transport System

K142366 · Puritan Medical Products, LLC · JSM · Jan 9, 2015 · Microbiology

Device Facts

• Record ID: K142366
• Device Name: Puritan OptiTranz Liquid Stuart Collection and Transport System
• Applicant: Puritan Medical Products, LLC
• Product Code: JSM · Microbiology
• Decision Date: Jan 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2390
• Device Class: Class 1

Indications for Use

Puritan OptiTranz Liquid Stuart Collection and Transport System is intended for use in the collection and transport of clinical specimen containing aerobic and fastidious bacteria from patient to the laboratory for bacteriological examination and culture.

Device Story

System consists of sterile peel pouch containing rayon or flock tipped swab and polypropylene tube with 1 ml liquid Stuart medium; medium is nonnutritive balanced salt solution with phosphates, calcium chloride, and mercaptoacetic acid to maintain osmotic balance and reduced environment. Used in clinical settings for specimen collection; swab used to collect sample, then placed in tube for transport to laboratory. Maintains viability of aerobic and fastidious bacteria during transport. Healthcare providers use the system to ensure specimen integrity for subsequent culture and bacteriological examination, facilitating accurate diagnosis of bacterial infections.

Clinical Evidence

Bench testing only. Recovery testing performed per CLSI M40-A2 guidelines comparing subject device to predicate using ATCC type cultures and clinically significant microorganisms. No significant differences in recovery detected. Stability testing confirmed microbial recovery up to 18-month expiry. pH stability verified over 18 months. Cytotoxicity testing (ISO Elution Method-1X MEM Extract) showed no evidence of cytotoxicity.

Technological Characteristics

Materials: Rayon or flock tipped swabs, plastic shaft, polypropylene tube. Medium: Nonnutritive balanced salt solution (calcium chloride 0.1g/L, mercaptoacetic acid 1.0g/L, sodium glycerophosphate 10.0g/L). pH: 7.3 ± 0.2. Sterilization: Gamma irradiation per ANSI/AAMI/ISO 11137:2006. Shelf life: 18 months at room temperature.

Indications for Use

Indicated for the collection and transport of clinical specimens containing aerobic and fastidious bacteria from patients to the laboratory for bacteriological examination and 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

• BD CultureSwab Collection and Transport System (K946283)

Submission Summary (Full Text)

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

A. 510(k) Number:
K142366

B. Purpose for Submission:
To make a substantial equivalence determination for the Puritan Optitranz Liquid Stuart Collection and Transport System intended for the collection and transport of clinical specimens containing aerobic and fastidious microorganisms from the clinic to the laboratory.

C. Measurand:
Not applicable

D. Type of Test:
Collection and transport culture media system

E. Applicant:
Puritan Medical Products LLC

F. Proprietary and Established Names:
Puritan® Optitranz™ Liquid Stuart Collection and Transport System

G. Regulatory Information:
1. Regulation section:
21 CFR 866.2390 – Transport culture medium
2. Classification:
Class I (general controls)
3. Product code:
JSM: Transport culture media

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LIO: Device, Specimen Collection

JTW: System transport aerobic

4. Panel:

Microbiology (83)

H. Intended Use:

1. Intended use(s):

Puritan OptiTranz Liquid Stuart Collection and Transport System is intended for use in the collection and transport of clinical specimen containing aerobic and fastidious bacteria from patient to the laboratory for bacteriological examination and culture.

2. Indication(s) for use:

Same as intended use.

3. Special conditions for use statement(s):

For in vitro diagnostic use only

For prescription use only

4. Special instrument requirements:

None

I. Device Description:

Puritan OptiTranz Liquid Stuart Collection and Transport System is comprised of a sterile peel pouch containing a rayon or flock tipped swab applicator for collecting specimen and a polypropylene tube containing 1 ml of liquid Stuart medium.

Puritan OptiTranz Liquid Stuart Medium is a nonnutritive balanced salt solution containing phosphates to provide buffering capability and calcium chloride to provide essential ions that help maintain osmotic balance. Mercaptoacetic acid provides a reduced environment. It is recommended for maintaining the viability of aerobic and fastidious bacteria during the transport to the laboratory.

Approximate Puritan OptiTranz liquid Stuart medium formulation per liter

| Calcium Chloride | 0.1g |
| --- | --- |
| Mercaptoacetic Acid | 1.0g |
| Sodium Glycerophosphate | 10.0g |

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J. Substantial Equivalence Information:

1. Predicate device name(s):
BD Culture Swab collection and transport system, manufactured by Copan Venturi, Transystem Liquid Stuarts Medium

2. Predicate 510(k) number(s):
K946283

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Puritan OptiTranz Liquid Stuart Collection and Transport System K142366 | BD CultureSwab™ Collection and Transport K946283 |
| Intended USE | Puritan OptiTranz Liquid Stuart Collection and Transport System is intended for use in the collection and transport of clinical specimen containing aerobic and fastidious bacteria from patient to the laboratory for bacteriological examination and culture. | Copan Venturi Transystem Liquid Stuarts Medium products (141C, 143C & 139C) are sterile ready-to-use systems intended for the safe collection, transport, and preservation of clinical specimens for bacteriological examination. Product 141C (plastic applicator) is intended for collecting samples from the throat, vagina or from wounds. Product 143C (aluminum applicator) is intended for collection of specimens from small or less accessible areas such as the eye, ear, nose, throat, urogenital tract and for pediatric use. Product 139C (two plastic applicators) is used for throat, vaginal or wound sampling. The double swab permits use of the second sample in the laboratory for gram stain analysis or as a backup for verification of initial culture. |

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| Similarities | | |
| --- | --- | --- |
| Item | Puritan OptiTranz Liquid Stuart Collection and Transport System K142366 | BD CultureSwab™ Collection and Transport K946283 |
| Single-use Device | Yes | Same |
| Medium Formulation | Sodium Glycerophosphate Calcium Chloride Mercaptoacetic acid | Same |
| pH | 7.3 ± 0.2 | Same |
| Storage Temperature | 2-25°C (refrigerated and room temperature) | 5-25°C (refrigerated and room temperature) |
| Container | Plastic round bottom tube | Same |
| Product Configuration | Medium in tubes, Plug & polyurethane foam System including medium and swab in peel pouch option. | Same |
| Swab Shaft | Plastic | Same |
| Shelf Life | 18 months | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Swab Tip | Rayon or flock tipped swab | Rayon tipped swab |

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

Quality Control of Microbiological Transport Systems; Approved Standard-Second Edition. CLSI Standard M40-A2.

# L. Test Principle:

Not applicable

# M. Performance Characteristics (if/when applicable):

# 1. Analytical performance:

The performance characteristics of Puritan® OptiTranz Liquid Stuart Medium was determined using roll plate and swab elution methods outlined in The Clinical and Laboratory Standards Institute (CLSI) M40-A2 document. Rayon or flock tipped swabs designed for different applications were used. A variety of aerobic and one facultative organism were included in this study. The test organisms comprised of the ten ATCC strains five of which are recommended in the CLSI M40-A2 document for determining performance characteristics of swab transport systems. To determine the performance characteristics of Puritan OptiTranz Liquid Stuart Medium bacterial viability studies were performed. These

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studies were conducted under refrigerated (2-8°C) and room temperature (20-25°C) conditions. Rayon and flocked tipped swabs were inoculated in duplicate with specified volume of selective bacterial concentrations. These swabs were then placed in the transport vials containing Liquid Stuarts Media and held for 0, 24, and 48 hours; at the designated time intervals the swabs were removed and processed.

Organisms evaluated:

A. Aerobes

1. Pseudomonas aeruginosa ATCC BAA-427
2. Streptococcus pyogenes ATCC 19615
3. Streptococcus pneumoniae ATCC 6305
4. Haemophilus influenzae ATCC 10211

B. Fastidious

1. Neisseria gonorrhoeae ATCC 43069.

C. Additional organisms

1. Streptococcus agalactiae (Group B Strep) ATCC 13813,
2. Enterococcus faecalis(VRE) ATCC 51299,
3. Staphylococcus aureus (MRSA) ATCC 43300,
4. Bordetella parapertussis ATCC 15311
5. Bordetella pertussis ATCC 8467

Acceptance criteria for recovery of bacteria as recommended in the CLSI document M40-A2 are followed. Manual colony counts were conducted for the Roll-Plate Method and the Swab Elution Method at all three time intervals for each swab-organism combination, except Neisseria gonorrhoeae, and the average for each lot was recorded. Three dilutions were analyzed for each test organism and the dilution yielding zero-time colony counts between 94 to 300 CFU was reported. These viability results are acceptable.

Roll-Plate Method:

The results of the study by Roll-Plate Method are presented in Tables 1-4 below for 3 lots of Puritan OptiTranz Liquid Stuart Collection and Transport System. The results demonstrate that the Puritan OptiTranz Liquid Stuart Collection and Transport System were able to maintain acceptable viability of all organisms up to 48 hours at room temperature (20-25°C) and under refrigerated (4-8°C) conditions based on the acceptance criteria in CLSI M40-A2. For the transport system to demonstrate acceptable viability by the Roll Plate method, ≥5 CFU should be recovered following the specified maintenance time from the specific dilution that yielded time-zero plate counts closest to 300 CFU. Neisseria gonorrhoeae results support acceptable recoveries up to 24 h, as recommended in the CLSI guidance M40-A2. There is no CLSI M40-A2 interpretation for N. gonorrhoeae beyond 24 h of storage using the Roll Plate Method.

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Table 1. Bacterial recovery results for Puritan Liquid Stuart Medium using Rayon swabs and the Roll-Plate Method at room temperature conditions.

| Organism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFU's Recovered: Time 0 hrs | Average CFU's Recovered: Time 24 hrs | Average CFU's Recovered: Time 48 hrs |
| --- | --- | --- | --- | --- | --- |
| Pseudomonas aeruginosa ATCC BAA-427 | Diluted 10-4 | Puritan - 140609 | 188 | 104 | 68 |
| | | Puritan - 140610 | 270 | 147 | 54 |
| | | Puritan -140611 | 160 | 94 | 86 |
| Streptococcus pyogenes ATCC 19615 | Diluted 10-4 | Puritan - 140609 | 156 | 128 | 65 |
| | | Puritan - 140610 | 119 | 20 | 10 |
| | | Puritan -140611 | 178 | 100 | 44 |
| Streptococcus pneumoniae ATCC 6305 | Diluted 10-4 | Puritan - 140609 | 200 | 113 | 76 |
| | | Puritan - 140610 | 173 | 109 | 70 |
| | | Puritan -140611 | 148 | 100 | 49 |
| Haemophilus influenzae ATCC 10211 | Diluted 10-4 | Puritan - 140609 | 172 | 114 | 91 |
| | | Puritan - 140610 | 127 | 60 | 36 |
| | | Puritan -140611 | 138 | 107 | 27 |
| Bordetella parapertussis ATCC 15311 | Diluted 10-4 | Puritan - 140609 | 288 | 225 | 150 |
| | | Puritan - 140610 | 235 | 167 | 112 |
| | | Puritan -140611 | 240 | 152 | 120 |
| Bordetella pertussis ATCC 9797 | Diluted 10-4 | Puritan - 140609 | 167 | 79 | 70 |
| | | Puritan - 140610 | 175 | 132 | 92 |
| | | Puritan -140611 | 203 | 140 | 86 |
| Staphylococcus aureus (MRSA) ATCC 43300 | Diluted 10-4 | Puritan - 140609 | 166 | 125 | 99 |
| | | Puritan - 140610 | 286 | 263 | 114 |
| | | Puritan -140611 | 115 | 32 | 24 |
| Enterococcus faecalis (VRE) ATCC 51299 | Diluted 10-4 | Puritan - 140609 | 223 | 87 | 61 |
| | | Puritan - 140610 | 256 | 192 | 104 |
| | | Puritan -140611 | 216 | 112 | 80 |
| Streptococcus agalactiae (Group B Strep) ATCC 13813 | Diluted 10-4 | Puritan - 140609 | 158 | 117 | 82 |
| | | Puritan - 140610 | 252 | 107 | 80 |
| | | Puritan -140611 | 110 | 94 | 68 |
| Neisseria gonorrhoeae ATCC 43069 | Diluted 10-4 | Puritan - 140609 | 198 | 49 | |
| | | Puritan - 140610 | 199 | 17 | |
| | | Puritan -140611 | 280 | 80 | |

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Table 2. Bacterial recovery results for Puritan Liquid Stuart Medium using Rayon swabs and the Roll-Plate Method at refrigerated (2-8°C) conditions.

| Organism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFU's Recovered: Time 0 hrs | Average CFU's Recovered: Time 24 hrs | Average CFU's Recovered: Time 48 hrs |
| --- | --- | --- | --- | --- | --- |
| Pseudomonas aeruginosa ATCC BAA-427 | Diluted 10-4 | Puritan - 140609 | 188 | 175 | 179 |
| | | Puritan - 140610 | 270 | 246 | 223 |
| | | Puritan -140611 | 160 | 146 | 139 |
| Streptococcus pyogenes ATCC 19615 | Diluted 10-4 | Puritan - 140609 | 156 | 143 | 133 |
| | | Puritan - 140610 | 119 | 64 | 44 |
| | | Puritan -140611 | 178 | 168 | 96 |
| Streptococcus pneumoniae ATCC 6305 | Diluted 10-4 | Puritan - 140609 | 200 | 129 | 121 |
| | | Puritan - 140610 | 173 | 130 | 112 |
| | | Puritan -140611 | 148 | 113 | 70 |
| Haemophilus influenzae ATCC 10211 | Diluted 10-4 | Puritan - 140609 | 172 | 130 | 118 |
| | | Puritan - 140610 | 127 | 96 | 75 |
| | | Puritan -140611 | 138 | 99 | 62 |
| Bordetella parapertussis ATCC 15311 | Diluted 10-4 | Puritan - 140609 | 288 | 254 | 200 |
| | | Puritan - 140610 | 235 | 211 | 187 |
| | | Puritan -140611 | 240 | 208 | 172 |
| Bordetella pertussis ATCC 9797 | Diluted 10-4 | Puritan - 140609 | 167 | 100 | 96 |
| | | Puritan - 140610 | 175 | 155 | 128 |
| | | Puritan -140611 | 203 | 182 | 142 |
| Staphylococcus aureus (MRSA) ATCC 43300 | Diluted 10-4 | Puritan - 140609 | 166 | 145 | 120 |
| | | Puritan - 140610 | 286 | 275 | 271 |
| | | Puritan -140611 | 115 | 89 | 59 |
| Enterococcus faecalis (VRE) ATCC 51299 | Diluted 10-4 | Puritan - 140609 | 223 | 184 | 144 |
| | | Puritan - 140610 | 256 | 207 | 147 |
| | | Puritan -140611 | 216 | 188 | 177 |
| Streptococcus agalactiae (Group B Strep) ATCC 13813 | Diluted 10-4 | Puritan - 140609 | 158 | 127 | 101 |
| | | Puritan - 140610 | 252 | 243 | 132 |
| | | Puritan -140611 | 110 | 108 | 83 |
| Neisseria gonorrhoeae ATCC 43069 | Diluted 10-4 | Puritan - 140609 | 198 | 83 | |
| | | Puritan - 140610 | 199 | 124 | |
| | | Puritan -140611 | 280 | 150 | |

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Table 3. Bacterial recovery results for Puritan Liquid Stuart Medium using HydraFlock swabs and the Roll-Plate Method at room temperature conditions.

| Organism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFU's Recovered: Time 0 hrs | Average CFU's Recovered: Time 24 hrs | Average CFU's Recovered: Time 48 hrs |
| --- | --- | --- | --- | --- | --- |
| Pseudomonas aeruginosa ATCC BAA-427 | Diluted 10-4 | Puritan - 140609 | 236 | 49 | 56 |
| | | Puritan - 140610 | 223 | 150 | 79 |
| | | Puritan -140611 | 130 | 78 | 77 |
| Streptococcus pyogenes ATCC 19615 | Diluted 10-4 | Puritan - 140609 | 206 | 136 | 70 |
| | | Puritan - 140610 | 182 | 76 | 54 |
| | | Puritan -140611 | 151 | 95 | 59 |
| Streptococcus pneumoniae ATCC 6305 | Diluted 10-4 | Puritan - 140609 | 134 | 113 | 79 |
| | | Puritan - 140610 | 141 | 111 | 88 |
| | | Puritan -140611 | 217 | 157 | 116 |
| Haemophilus influenzae ATCC 10211 | Diluted 10-4 | Puritan - 140609 | 125 | 64 | 16 |
| | | Puritan - 140610 | 131 | 44 | 31 |
| | | Puritan -140611 | 164 | 104 | 46 |
| Bordetella parapertussis ATCC 15311 | Diluted 10-4 | Puritan - 140609 | 270 | 220 | 150 |
| | | Puritan - 140610 | 294 | 213 | 185 |
| | | Puritan -140611 | 256 | 216 | 160 |
| Bordetella pertussis ATCC 9797 | Diluted 10-4 | Puritan - 140609 | 114 | 32 | 13 |
| | | Puritan - 140610 | 136 | 45 | 24 |
| | | Puritan -140611 | 152 | 43 | 20 |
| Staphylococcus aureus (MRSA) ATCC 43300 | Diluted 10-4 | Puritan - 140609 | 137 | 101 | 76 |
| | | Puritan - 140610 | 300 | 184 | 145 |
| | | Puritan -140611 | 167 | 133 | 90 |
| Enterococcus faecalis (VRE) ATCC 51299 | Diluted 10-4 | Puritan - 140609 | 225 | 134 | 28 |
| | | Puritan - 140610 | 262 | 187 | 43 |
| | | Puritan -140611 | 160 | 98 | 49 |
| Streptococcus agalactiae (Group B Strep) ATCC 13813 | Diluted 10-4 | Puritan - 140609 | 177 | 131 | 81 |
| | | Puritan - 140610 | 117 | 63 | 35 |
| | | Puritan -140611 | 183 | 136 | 112 |
| Neisseria gonorrhoeae ATCC 43069 | Diluted 10-4 | Puritan - 140609 | 200 | 70 | |
| | | Puritan - 140610 | 106 | 22 | |
| | | Puritan -140611 | 230 | 83 | |

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Table 4. Bacterial recovery results for Puritan Liquid Stuart Medium using HydraFlock swabs and the Roll-Plate Method at refrigerated (2-8°C) conditions.

| Organism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFU's Recovered: Time 0 hrs | Average CFU's Recovered: Time 24 hrs | Average CFU's Recovered: Time 48 hrs |
| --- | --- | --- | --- | --- | --- |
| Pseudomonas aeruginosa ATCC BAA-427 | Diluted 10-4 | Puritan - 140609 | 236 | 190 | 164 |
| | | Puritan - 140610 | 223 | 199 | 176 |
| | | Puritan -140611 | 130 | 122 | 101 |
| Streptococcus pyogenes ATCC 19615 | Diluted 10-4 | Puritan - 140609 | 206 | 200 | 125 |
| | | Puritan - 140610 | 182 | 179 | 130 |
| | | Puritan -140611 | 151 | 107 | 82 |
| Streptococcus pneumoniae ATCC 6305 | Diluted 10-4 | Puritan - 140609 | 134 | 133 | 123 |
| | | Puritan - 140610 | 141 | 123 | 110 |
| | | Puritan -140611 | 217 | 155 | 121 |
| Haemophilus influenzae ATCC 10211 | Diluted 10-4 | Puritan - 140609 | 125 | 91 | 44 |
| | | Puritan - 140610 | 131 | 107 | 73 |
| | | Puritan -140611 | 164 | 109 | 58 |
| Bordetella parapertussis ATCC 15311 | Diluted 10-4 | Puritan - 140609 | 270 | 236 | 170 |
| | | Puritan - 140610 | 294 | 259 | 241 |
| | | Puritan -140611 | 256 | 232 | 200 |
| Bordetella pertussis ATCC 9797 | Diluted 10-4 | Puritan - 140609 | 114 | 41 | 36 |
| | | Puritan - 140610 | 136 | 92 | 55 |
| | | Puritan -140611 | 152 | 119 | 63 |
| Staphylococcus aureus (MRSA) ATCC 43300 | Diluted 10-4 | Puritan - 140609 | 137 | 122 | 106 |
| | | Puritan - 140610 | 300 | 281 | 223 |
| | | Puritan -140611 | 167 | 159 | 139 |
| Enterococcus faecalis (VRE) ATCC 51299 | Diluted 10-4 | Puritan - 140609 | 225 | 186 | 90 |
| | | Puritan - 140610 | 262 | 241 | 106 |
| | | Puritan -140611 | 160 | 129 | 91 |
| Streptococcus agalactiae (Group B Strep) ATCC 13813 | Diluted 10-4 | Puritan - 140609 | 177 | 144 | 98 |
| | | Puritan - 140610 | 117 | 92 | 60 |
| | | Puritan -140611 | 183 | 160 | 150 |
| Neisseria gonorrhoeae ATCC 43069 | Diluted 10-4 | Puritan - 140609 | 200 | 136 | |
| | | Puritan - 140610 | 106 | 55 | |
| | | Puritan -140611 | 230 | 116 | |

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# Swab Elution Method:

The results of the study by Swab Elution Method are presented in Tables 5-8 below for 3 lots of Puritan OptiTranz Liquid Stuart Collection and Transport System. The results demonstrate that the swabs from Puritan OptiTranz Liquid Stuart Collection and Transport System were able to maintain acceptable viability levels for all organisms up to 48 hours at room temperature (20-25°C) and under refrigerated (4-8°C) conditions based on the acceptance recovery criteria in CLSI M40-A2. For viability in the Swab Elution Method to be considered acceptable there shall be no more than a 3 log₁₀ (1 × 10³ +/- 10%) decline in CFU between the zero-time CFU count and the CFU of the swabs that were stored. *Neisseria gonorrhoeae* results support acceptable recoveries up to 24 h, as recommended in the CLSI guidance M40-A2. There is no CLSI M40-A2 interpretation for *N. gonorrhoeae* beyond 24 h of storage using the Swab Elution Method.

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Table 5. Bacterial recovery results for Puritan Liquid Stuart Medium using Rayon swabs and the Swab Elution Method at room temperature conditions.

| Organism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFU's Recovered: Time 0 hrs | Average CFU's Recovered: Time 24 hrs | Average CFU's Recovered: Time 48 hrs | Log10 Decline |
| --- | --- | --- | --- | --- | --- | --- |
| Pseudomonas aeruginosa ATCC BAA-427 | Diluted 1:10 | Puritan - 140609 | 1.5 x 106 | 6.8 x 105 | 3.3 x 105 | -0.66 |
| | | Puritan - 140610 | 2.2 x 106 | 5.3 x 105 | 2.8 x 105 | -0.90 |
| | | Puritan -140611 | 2.0 x 106 | 6.0 x 105 | 1.9 x 105 | -1.02 |
| Streptococcus pyogenes ATCC 19615 | Diluted 1:10 | Puritan - 140609 | 2.1 x 106 | 7.5 x 105 | 6.7 x 105 | -0.50 |
| | | Puritan - 140610 | 1.8 x 106 | 4.4 x 105 | 3.5 x 105 | -0.71 |
| | | Puritan -140611 | 2.1 x 106 | 9.7 x 105 | 7.4 x 105 | -0.45 |
| Streptococcus pneumoniae ATCC 6305 | Diluted 1:10 | Puritan - 140609 | 1.8 x 106 | 6.0 x 105 | 4.4 x 105 | -0.61 |
| | | Puritan - 140610 | 1.7 x 106 | 8.8 x 105 | 5.0 x 105 | -0.53 |
| | | Puritan -140611 | 2.0 x 106 | 8.6 x 105 | 4.1 x 105 | -0.69 |
| Haemophilus influenzae ATCC 10211 | Diluted 1:10 | Puritan - 140609 | 1.0 x 106 | 2.4 x 105 | 7.6 x 104 | -1.12 |
| | | Puritan - 140610 | 9.6 x 105 | 3.9 x 105 | 9.8 x 104 | -0.99 |
| | | Puritan -140611 | 1.3 x 106 | 3.3 x 105 | 8.8 x 104 | -1.17 |
| Bordetella parapertussis ATCC 15311 | Diluted 1:10 | Puritan - 140609 | 1.1 x 106 | 2.9 x 105 | 9.1 x 104 | -1.08 |
| | | Puritan - 140610 | 1.4 x 106 | 3.9 x 105 | 1.2 x 105 | -1.07 |
| | | Puritan -140611 | 1.1 x 106 | 3.8 x 105 | 9.7 x 104 | -1.05 |
| Bordetella pertussis ATCC 9797 | Diluted 1:10 | Puritan - 140609 | 1.4 x 106 | 7.9 x 105 | 5.3 x 104 | -1.42 |
| | | Puritan - 140610 | 1.6 x 106 | 6.1 x 105 | 8.8 x 104 | -1.26 |
| | | Puritan -140611 | 1.8 x 106 | 6.2 x 105 | 2.2 x 105 | -0.91 |
| Staphylococcus aureus (MRSA) ATCC 43300 | Diluted 1:10 | Puritan - 140609 | 2.2 x 106 | 5.5 x 105 | 1.7 x 105 | -1.11 |
| | | Puritan - 140610 | 2.5 x 106 | 5.1 x 105 | 3.9 x 105 | -0.81 |
| | | Puritan -140611 | 2.4 x 106 | 6.4 x 105 | 1.4 x 105 | -1.23 |
| Enterococcus faecalis (VRE) ATCC 51299 | Diluted 1:10 | Puritan - 140609 | 2.0 x 106 | 6.0 x 105 | 4.1 x 105 | -0.69 |
| | | Puritan - 140610 | 2.2 x 106 | 6.3 x 105 | 5.4 x 105 | -0.61 |
| | | Puritan -140611 | 1.9 x 106 | 5.6 x 105 | 3.3 x 105 | -0.76 |
| Streptococcus agalactiae (Group B Strep) ATCC 13813 | Diluted 1:10 | Puritan - 140609 | 1.4 x 106 | 5.9 x 105 | 1.0 x 105 | -1.15 |
| | | Puritan - 140610 | 1.2 x 106 | 5.0 x 105 | 7.2 x 104 | -1.22 |
| | | Puritan -140611 | 9.4 x 105 | 4.5 x 105 | 5.9 x 104 | -1.20 |
| Neisseria gonorrhoeae ATCC 43069 | Diluted 1:10 | Puritan - 140609 | 2.1 x 106 | 1.1 x 105 | | -1.28 |
| | | Puritan - 140610 | 2.4 x 106 | 9.0 x 104 | | -1.43 |
| | | Puritan -140611 | 2.0 x 106 | 8.3 x 104 | | -1.38 |

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Table 6. Bacterial recovery results for Puritan Liquid Stuart Medium using Rayon swabs and the Swab Elution Method at refrigerated (2-8°C) conditions.

| Organism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFU's Recovered: Time 0 hrs | Average CFU's Recovered: Time 24 hrs | Average CFU's Recovered: Time 48 hrs | Log10 Decline |
| --- | --- | --- | --- | --- | --- | --- |
| Pseudomonas aeruginosa ATCC BAA-427 | Diluted 1:10 | Puritan - 140609 | 1.5 x 106 | 1.6 x 106 | 8.5 x 105 | -0.25 |
| | | Puritan - 140610 | 2.2 x 106 | 2.5 x 106 | 9.2 x 105 | -0.38 |
| | | Puritan -140611 | 2.0 x 106 | 2.4 x 106 | 7.9 x 105 | -0.40 |
| Streptococcus pyogenes ATCC 19615 | Diluted 1:10 | Puritan - 140609 | 2.1 x 106 | 2.0 x 106 | 5.6 x 105 | -0.57 |
| | | Puritan - 140610 | 1.8 x 106 | 1.5 x 106 | 7.0 x 105 | -0.41 |
| | | Puritan -140611 | 2.1 x 106 | 1.7 x 106 | 9.5 x 105 | -0.34 |
| Streptococcus pneumoniae ATCC 6305 | Diluted 1:10 | Puritan - 140609 | 1.8 x 106 | 1.5 x 106 | 3.0 x 105 | -0.78 |
| | | Puritan - 140610 | 1.7 x 106 | 1.2 x 106 | 5.8 x 105 | -0.47 |
| | | Puritan -140611 | 2.0 x 106 | 1.5 x 106 | 9.3 x 105 | -0.33 |
| Haemophilus influenzae ATCC 10211 | Diluted 1:10 | Puritan - 140609 | 1.0 x 106 | 9.9 x 105 | 4.1 x 105 | -0.39 |
| | | Puritan - 140610 | 9.6 x 105 | 9.0 x 105 | 2.6 x 105 | -0.57 |
| | | Puritan -140611 | 1.3 x 106 | 1.1 x 106 | 7.8 x 105 | -0.22 |
| Bordetella parapertussis ATCC 15311 | Diluted 1:10 | Puritan - 140609 | 1.1 x 106 | 1.0 x 106 | 7.7 x 105 | -0.15 |
| | | Puritan - 140610 | 1.4 x 106 | 1.3 x 106 | 6.9 x 105 | -0.31 |
| | | Puritan -140611 | 1.1 x 106 | 1.1 x 106 | 7.0 x 105 | -0.20 |
| Bordetella pertussis ATCC 9797 | Diluted 1:10 | Puritan - 140609 | 1.4 x 106 | 1.2 x 106 | 8.1 x 105 | -0.24 |
| | | Puritan - 140610 | 1.6 x 106 | 1.5 x 106 | 6.6 x 105 | -0.38 |
| | | Puritan -140611 | 1.8 x 106 | 1.4 x 106 | 7.9 x 105 | -0.36 |
| Staphylococcus aureus (MRSA) ATCC 43300 | Diluted 1:10 | Puritan - 140609 | 2.2 x 106 | 2.0 x 106 | 5.5 x 105 | -0.60 |
| | | Puritan - 140610 | 2.5 x 106 | 2.4 x 106 | 5.1 x 105 | -0.69 |
| | | Puritan -140611 | 2.4 x 106 | 2.1 x 106 | 8.5 x 105 | -0.45 |
| Enterococcus faecalis (VRE) ATCC 51299 | Diluted 1:10 | Puritan - 140609 | 2.0 x 106 | 1.7 x 106 | 8.6 x 105 | -0.37 |
| | | Puritan - 140610 | 2.2 x 106 | 2.0 x 106 | 5.9x 105 | -0.57 |
| | | Puritan -140611 | 1.9 x 106 | 1.8 x 106 | 3.9 x 105 | -0.69 |
| Streptococcus agalactiae (Group B Strep) ATCC 13813 | Diluted 1:10 | Puritan - 140609 | 1.4 x 106 | 1.3 x 106 | 9.3 x 105 | -0.18 |
| | | Puritan - 140610 | 1.2 x 106 | 9.7 x 105 | 6.3 x 105 | -0.28 |
| | | Puritan -140611 | 9.4 x 105 | 8.2 x 105 | 3.9 x 105 | -0.38 |
| Neisseria gonorrhoeae ATCC 43069 | Diluted 1:10 | Puritan - 140609 | 2.1 x 106 | 8.5 x 105 | | -0.39 |
| | | Puritan - 140610 | 2.4 x 106 | 7.8 x 105 | | -0.49 |
| | | Puritan -140611 | 2.0 x 106 | 1.3 x 106 | | -0.19 |

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Table 7. Bacterial recovery results for Puritan Liquid Stuart Medium using HydraFlock swabs and the Swab Elution Method at room temperature conditions.

| Organism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFU's Recovered: Time 0 hrs | Average CFU's Recovered: Time 24 hrs | Average CFU's Recovered: Time 48 hrs | Log10 Decline |
| --- | --- | --- | --- | --- | --- | --- |
| Pseudomonas aeruginosa ATCC BAA-427 | Diluted 1:10 | Puritan - 140609 | 2.7 x 106 | 8.9 x 105 | 3.6 x 105 | -0.88 |
| | | Puritan - 140610 | 2.4 x 106 | 7.5 x 105 | 1.9 x 105 | -1.10 |
| | | Puritan -140611 | 2.6 x 106 | 7.4 x 105 | 5.1 x 105 | -0.71 |
| Streptococcus pyogenes ATCC 19615 | Diluted 1:10 | Puritan - 140609 | 2.1 x 106 | 6.9 x 105 | 2.9 x 105 | -0.86 |
| | | Puritan - 140610 | 2.4 x 106 | 7.4 x 105 | 3.5 x 105 | -0.84 |
| | | Puritan -140611 | 2.5 x 106 | 8.3 x 105 | 4.1 x 105 | -0.79 |
| Streptococcus pneumoniae ATCC 6305 | Diluted 1:10 | Puritan - 140609 | 2.3 x 106 | 5.5 x 105 | 1.2 x 105 | -1.28 |
| | | Puritan - 140610 | 2.2 x 106 | 6.2 x 105 | 2.0 x 105 | -1.04 |
| | | Puritan -140611 | 2.7 x 106 | 7.3 x 105 | 3.0 x 105 | -0.95 |
| Haemophilus influenzae ATCC 10211 | Diluted 1:10 | Puritan - 140609 | 2.1 x 106 | 8.1 x 105 | 2.6 x 105 | -0.91 |
| | | Puritan - 140610 | 2.3 x 106 | 7.8 x 105 | 1.6 x 105 | -1.16 |
| | | Puritan -140611 | 1.9 x 106 | 7.5 x 105 | 1.2 x 105 | -1.20 |
| Bordetella parapertussis ATCC 15311 | Diluted 1:10 | Puritan - 140609 | 1.8 x 106 | 8.3 x 105 | 6.8 x 105 | -0.42 |
| | | Puritan - 140610 | 1.9 x 106 | 8.8 x 105 | 5.2 x 105 | -0.56 |
| | | Puritan -140611 | 2.2 x 106 | 9.8 x 105 | 4.2 x 105 | -0.72 |
| Bordetella pertussis ATCC 9797 | Diluted 1:10 | Puritan - 140609 | 1.7 x 106 | 6.3 x 105 | 1.5 x 105 | -1.05 |
| | | Puritan - 140610 | 2.0 x 106 | 6.8 x 105 | 2.4 x 105 | -0.92 |
| | | Puritan -140611 | 1.6 x 106 | 7.2 x 105 | 1.1 x 105 | -1.16 |
| Staphylococcus aureus (MRSA) ATCC 43300 | Diluted 1:10 | Puritan - 140609 | 2.4 x 106 | 5.9 x 105 | 2.0 x 105 | -1.08 |
| | | Puritan - 140610 | 2.8 x 106 | 6.6 x 105 | 3.1 x 105 | -0.96 |
| | | Puritan -140611 | 2.8 x 106 | 5.8 x 105 | 2.7 x 105 | -1.02 |
| Enterococcus faecalis (VRE) ATCC 51299 | Diluted 1:10 | Puritan - 140609 | 2.3 x 106 | 9.3 x 105 | 3.3 x 105 | -0.84 |
| | | Puritan - 140610 | 2.0 x 106 | 8.8 x 105 | 4.6 x 105 | -0.64 |
| | | Puritan -140611 | 2.4 x 106 | 7.8 x 105 | 2.9 x 105 | -0.92 |
| Streptococcus agalactiae (Group B Strep) ATCC 13813 | Diluted 1:10 | Puritan - 140609 | 1.7 x 106 | 3.0 x 105 | 1.0 x 105 | -1.23 |
| | | Puritan - 140610 | 1.9 x 106 | 4.6 x 105 | 2.5 x 105 | -0.88 |
| | | Puritan -140611 | 1.6 x 106 | 4.9 x 105 | 2.8 x 105 | -0.76 |
| Neisseria gonorrhoeae ATCC 43069 | Diluted 1:10 | Puritan - 140609 | 1.3 x 106 | 2.8 x 105 | | -0.67 |
| | | Puritan - 140610 | 1.2 x 106 | 1.8 x 105 | | -0.82 |
| | | Puritan -140611 | 1.6 x 106 | 1.0 x 105 | | -1.20 |

{13}

Table 8. Bacterial recovery results for Puritan Liquid Stuart Medium using HydraFlock swabs and the Swab Elution Method at refrigerated (2-8°C) conditions.

| Organism | 0.5 McFarland microorganism suspension diluted with saline | Product Lot Numbers | Average CFU's Recovered: Time 0 hrs | Average CFU's Recovered: Time 24 hrs | Average CFU's Recovered: Time 48 hrs | Log10 Decline |
| --- | --- | --- | --- | --- | --- | --- |
| Pseudomonas aeruginosa ATCC BAA-427 | Diluted 1:10 | Puritan - 140609 | 2.7 x 106 | 1.9 x 106 | 1.2 x 106 | -0.35 |
| | | Puritan - 140610 | 2.4 x 106 | 9.5 x 105 | 8.3 x 105 | -0.46 |
| | | Puritan -140611 | 2.6 x 106 | 9.9 x 105 | 8.1 x 105 | -0.51 |
| Streptococcus pyogenes ATCC 19615 | Diluted 1:10 | Puritan - 140609 | 2.1 x 106 | 9.3 x 105 | 5.3 x 105 | -0.60 |
| | | Puritan - 140610 | 2.4 x 106 | 8.9 x 105 | 7.8 x 105 | -0.49 |
| | | Puritan -140611 | 2.5 x 106 | 8.3 x 105 | 6.0 x 105 | -0.62 |
| Streptococcus pneumoniae ATCC 6305 | Diluted 1:10 | Puritan - 140609 | 2.3 x 106 | 8.5 x 105 | 4.3 x 105 | -0.73 |
| | | Puritan - 140610 | 2.2 x 106 | 8.8 x 105 | 6.1 x 105 | -0.56 |
| | | Puritan -140611 | 2.7 x 106 | 9.0 x 105 | 6.0 x 105 | -0.65 |
| Haemophilus influenzae ATCC 10211 | Diluted 1:10 | Puritan - 140609 | 2.1 x 106 | 1.8 x 106 | 5.9 x 105 | -0.55 |
| | | Puritan - 140610 | 2.3 x 106 | 1.7 x 106 | 3.8 x 105 | -0.78 |
| | | Puritan -140611 | 1.9 x 106 | 1.9 x 106 | 6.5 x 105 | -0.47 |
| Bordetella parapertussis ATCC 15311 | Diluted 1:10 | Puritan - 140609 | 1.8 x 106 | 9.8 x 105 | 8.3 x 105 | -0.34 |
| | | Puritan - 140610 | 1.9 x 106 | 9.6 x 105 | 8.0 x 105 | -0.38 |
| | | Puritan -140611 | 2.2 x 106 | 1.3 x 106 | 7.6 x 105 | -0.46 |
| Bordetella pertussis ATCC 9797 | Diluted 1:10 | Puritan - 140609 | 1.7 x 106 | 9.4 x 105 | 6.9x 105 | -0.39 |
| | | Puritan - 140610 | 2.0 x 106 | 8.8 x 105 | 7.4 x 105 | -0.43 |
| | | Puritan -140611 | 1.6 x 106 | 9.0 x 105 | 7.5 x 105 | -0.33 |
| Staphylococcus aureus (MRSA) ATCC 43300 | Diluted 1:10 | Puritan - 140609 | 2.4 x 106 | 1.5 x 106 | 9.2 x 105 | -0.42 |
| | | Puritan - 140610 | 2.8 x 106 | 1.8 x 106 | 7.0 x 105 | -0.60 |
| | | Puritan -140611 | 2.8 x 106 | 2.0 x 106 | 8.7 x 105 | -0.51 |
| Enterococcus faecalis (VRE) ATCC 51299 | Diluted 1:10 | Puritan - 140609 | 2.3 x 106 | 9.9 x 105 | 8.9 x 105 | -0.41 |
| | | Puritan - 140610 | 2.0 x 106 | 9.2 x 105 | 6.5 x 105 | -0.49 |
| | | Puritan -140611 | 2.4 x 106 | 1.1 x 106 | 5.4 x 105 | -0.65 |
| Streptococcus agalactiae (Group B Strep) ATCC 13813 | Diluted 1:10 | Puritan - 140609 | 1.7 x 106 | 9.3 x 105 | 7.9 x 105 | -0.33 |
| | | Puritan - 140610 | 1.9 x 106 | 8.7 x 105 | 5.3 x 105 | -0.55 |
| | | Puritan -140611 | 1.6 x 106 | 8.1 x 105 | 5.9 x 105 | -0.43 |
| Neisseria gonorrhoeae ATCC 43069 | Diluted 1:10 | Puritan - 140609 | 1.3 x 106 | 4.9 x 105 | | -0.42 |
| | | Puritan - 140610 | 1.2 x 106 | 6.5 x 105 | | -0.27 |
| | | Puritan -140611 | 1.6 x 106 | 6.8 x 105 | | -0.37 |

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15

# Overgrowth Evaluation:

Viability performance studies on all of the organisms above also included an assessment of performance evaluation and overgrowth per CLSI M40-A2 8.12.4 for roll plate method. Overgrowth assessment as defined in CLSI M40-A2 guideline is greater than one-log10 increase in CFU between zero-time and the holding time point. There was no increase in bacterial count for all organisms tested when the samples were stored at room temperature. The data provided is in conformance with the guidelines in CLSI M40-A2 at room temperature.

a. Precision/Reproducibility:

Not applicable.

b. Linearity/assay reportable range:

Not applicable.

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

Accelerated shelf life stability test were performed successfully on 3 lots of product demonstrating stability for up to 18 months at room temperature.

pH Stability: The pH of the test device was measured at predetermined time intervals up to 18 month after manufacturing date. The test was performed using calibrated pH meter with random samples from three different lots of Puritan OptiTranz liquid Stuart Medium. All samples tested were found to maintain pH within the specified range of 7.3 +/- 0.2.

Cytotoxicity: Cytotoxicity test was conducted to evaluate glue, shaft, rayon or flock tipped swabs for potential cytotoxicity effect following ISO Elution Method-1X MEM Extract. Historically the ISO Elution method is used for cytotoxicity because cytotoxicity is not addressed in CLSI M40-A2 for swab transport devices. No evidence of cytotoxicity was detected as no cell lysis and no reduction in cell growth were observed.

Sterilization: Puritan OptiTranz liquid Stuart Medium 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:

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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 done to determine the ability of the Puritan OptiTranz Liquid Stuart Collection and Transport System to maintain viability of different strains of aerobic bacteria. It showed recovery of bacteria within the acceptance criteria recommended in the CLSI M40-A2 and similar to the predicate device. (See above under Performance Characteristics).

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.

16

{16}

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.

17