← Product Code [LIO](/submissions/MI/subpart-c%E2%80%94microbiology-devices/LIO) · K120846

# TRANSPORT CULTURE MEDIUM DEVICE (K120846)

_Puritan Medical Products, LLC · LIO · Jun 8, 2012 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/LIO/K120846

## Device Facts

- **Applicant:** Puritan Medical Products, LLC
- **Product Code:** [LIO](/submissions/MI/subpart-c%E2%80%94microbiology-devices/LIO.md)
- **Decision Date:** Jun 8, 2012
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.2900
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Indications for Use

The Puritan® Liquid Amies Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.

## Device Story

System for collecting/transporting bacteriological specimens; maintains viability of aerobes, anaerobes, and fastidious bacteria during transit. Components: sterile peel-open pouch, pre-scored HydraFlock® flocked swab (polyester fibers), and polypropylene screw-cap vial containing 1 ml modified liquid Amies medium. Medium is non-nutritive, phosphate-buffered; contains thioglycolate salt for reduced environment and chloride salts for osmotic balance. Used in clinical settings; operated by healthcare professionals. Swab collects specimen; placed in vial for transport to laboratory. Medium preserves bacterial viability until processing. Benefits: maintains specimen integrity during delays between collection and laboratory analysis.

## Clinical Evidence

Bench testing only. Recovery testing performed per CLSI M40-A guidelines using ATCC type cultures and clinically significant microorganisms to compare viability maintenance against predicate. Stability testing confirmed microbial recovery up to 18-month expiry. pH stability verified over 18 months. Cytotoxicity evaluated via ISO Elution Method-1X MEM Extract; no cytotoxicity detected.

## Technological Characteristics

System includes HydraFlock polyester flocked swab and 1 ml modified liquid Amies medium (sodium chloride, disodium phosphate, sodium thioglycolate, monopotassium phosphate, potassium chloride, calcium chloride, magnesium chloride). Sterilized by gamma irradiation per ANSI/AAMI/ISO 11137:2006. Non-nutritive, phosphate-buffered transport medium.

## Regulatory Identification

A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

## Predicate Devices

- BD Liquid Amies Elution Swab (ESwab) Collection and Transport System ([K061301](/device/K061301.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number: K120846

B. Purpose for Submission: New device

C. Measurand: Not applicable (N/A)

D. Type of Test: Transport culture medium device

E. Applicant: Puritan Medical Products LLC

F. Proprietary and Established Names: Puritan® Liquid Amies Collection and Transport System

G. Regulatory Information:

1. Regulation section: 21 CFR§866.2900; Microbiological specimen collection and transport device

2. Classification: Class I

3. Product code: LIO: Device, Specimen Collection
JTW: System, Transport, Aerobic
JTX: Transport Systems, Anaerobic

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4. Panel: 83 Microbiology

H. Intended Use:

1. Intended use(s):

The Puritan® Liquid Amies Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.

2. Indication(s) for use:

The Puritan® Liquid Amies Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture.

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

4. Special instrument requirements: None

I. Device Description:

Specialized systems for collecting and transporting bacteriological specimens are commonly used in laboratories to aid in the diagnosis of bacterial infections, especially when there is a delay between specimen collection and processing.

The Puritan® Liquid Amies Collection and Transport System consists of a sterile peel-open pouch containing a pre-scored HydraFlock® flocked swab and a polypropylene screw-cap vial containing 1 ml of modified liquid Amies medium. HydraFlock® multiple split polyester fibers facilitate quick absorption and release of clinical specimens. HydraFlock® flocked swabs are available in various score points and configurations to facilitate specimen collection from various sites on patients' bodies. Modified liquid Amies transport medium is a non-nutritive phosphate-buffered medium capable of maintaining the viability of aerobic, anaerobic, and fastidious bacteria such as Neisseria

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gonorrhoeae during transport to the laboratory. It also contains thioglycolate salt to provide a reduced environment and chloride salts to help maintain osmotic balance and control permeability of bacterial cells.

Approximate modified liquid Amies medium formulation per liter

|  Sodium chloride | 3.0g  |
| --- | --- |
|  Disodium phosphate | 1.2g  |
|  Sodium thioglycolate | 1.0g  |
|  Monopotassium phosphate | 0.2g  |
|  Potassium chloride | 0.2g  |
|  Calcium chloride | 0.1g  |
|  Magnesium chloride | 0.1g  |

# J. Substantial Equivalence Information:

1. Predicate device name(s): BD Liquid Amies Elution Swab (ESwab) Collection and Transport System
2. Predicate 510(k) number(s): K061301
3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Intended Use | The Puritan® Liquid Amies Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture. | BD™ Liquid Amies Elution Swab (ESwab) Collection and Transport System is intended for the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the collection site to the testing laboratory. In the laboratory, BD ESwab specimens are processed using standard clinical laboratory operating  |

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|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Base Medium | Liquid Amies medium | procedures for bacterial culture.  |
|  Product Configuration | Medium and swab in peel pouch | Same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Swab Tip | HydraFlock® Swab (Polyester) | Nylon Flock Swab  |

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

1. Quality Control of Microbiological Transport Systems, M40-A, Clinical Laboratory and Standards Institute (CLSI), Wayne, PA, 2003. [The standard was mentioned for informational purpose only. No claims were made]

## L. Test Principle: Not applicable (N/A)

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

### 1. Analytical performance:

The performance characteristics of Puritan® Liquid Amies Collection and Transport System were determined using the procedures outlined in the Clinical Laboratory Standards Institute (CLSI) M40-A document. A variety of aerobic, anaerobic, and fastidious organisms were included in this study. The test organisms comprised of the ten ATCC strains that are recommended in the CLSI M40-A document for determining performance characteristics of swab transport systems. To determine the performance characteristics of the Puritan® Liquid Amies Collection and Transport System, bacterial viability studies were performed. These studies were conducted at two different temperatures to reflect refrigerated (4-8°C) and room temperature (20-25°C) conditions. The swabs from each transport system were inoculated in duplicate with a specified volume of select bacterial concentrations. These swabs were then placed in their respective transport vial and held for 0, 24, and 48 hours; at the designated time intervals the swabs were removed and processed. These studies were conducted using both the Roll-Plate and Swab Elution Methods.

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Organisms evaluated:

A. Aerobes and Facultative Anaerobes:

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

B. Anaerobes

1. Bacteroides fragilis ATCC 25285,
2. Peptostreptococcus anaerobius ATCC 27337,
3. Fusobacterium nucleatum ATCC 25586,
4. Propionibacterium acnes ATCC 6919,
5. Prevotella melaninogenica ATCC 25845.

C. Fastidious

1. Neisseria gonorrhoeae ATCC 43069

Acceptance criteria for recovery of bacteria as recommended in the CLSI document M40-A are followed. For Roll-Plate Method viability results to be considered acceptable, there shall be $\geq 5$ CFU following the specified holding time from the specific dilution that yielded zero-time plate counts closest to 300 CFU. For results by Swab Elution Method to be considered acceptable there shall be no more than a 3 log$_{10}$ (1 x 10$^{3}$ +/- 10%) decline in CFU between the zero-time CFU count and the CFU of the swabs that were stored.

The results of the study by Roll-Plate Method and the Swab Elution Method are presented in Tables 1-4. The results demonstrate the ability of Puritan® Liquid Amies Collection and Transport System to sustain the viability and recovery of test bacteria within acceptance criteria for at least 48 h at refrigerated (4 - 8°C) and room temperatures (20 - 25°C). Neisseria gonorrhoeae results support acceptable recoveries up to 24 h as recommended in the CLSI guidance M40-A.

Viability performance studies also included an assessment of bacterial overgrowth at refrigerated temperature. Overgrowth assessment as defined in CLSI M40-A guideline is greater than 1 log10 increase in CFU between zero-time and the holding time point. There was no increase in bacterial count when the samples were stored at 4 - 8°C for 48 h and analyzed by the Roll-Plate Method (Table 2) and the Swab Elution Method (Table 4).

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Table 1. Bacterial recovery results for the Roll-Plate Method at room temperature.

|  Organism | 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  |
| --- | --- | --- | --- | --- | --- |
|  Pseudomonas aeruginosa ATCC BAA-427 | Diluted 10-4 | Puritan - 111101 | 308 | 310 | 81  |
|   |   |  Puritan - 110907 | 241 | 251 | 111  |
|   |   |  Puritan - 111209 | 267 | 260 | 106  |
|  Streptococcus pyogenes ATCC 19615 | Diluted 10-4 | Puritan - 111101 | 250 | 204 | 77  |
|   |   |  Puritan - 110907 | 194 | 210 | 131  |
|   |   |  Puritan - 111209 | 245 | 191 | 77  |
|  Streptococcus pneumoniae ATCC 6305 | Diluted 10-4 | Puritan - 111101 | 134 | 101 | 34  |
|   |   |  Puritan - 110907 | 200 | 88 | 65  |
|   |   |  Puritan - 111209 | 171 | 164 | 74  |
|  Haemophilus influenzae ATCC 10211 | Diluted 10-4 | Puritan - 111101 | 264 | 254 | 82  |
|   |   |  Puritan - 110907 | 236 | 136 | 48  |
|   |   |  Puritan - 111209 | 250 | 198 | 61  |
|  Bacteroides fragilis ATCC 25285 | Diluted 10-3 | Puritan - 111101 | 320 | 265 | 109  |
|   |   |  Puritan - 110907 | 200 | 117 | 64  |
|   |   |  Puritan - 111209 | 270 | 285 | 105  |
|  Peptostreptococcus anaerobius ATCC 27337 | Diluted 10-3 | Puritan - 111101 | 265 | 118 | 41  |
|   |   |  Puritan - 110907 | 260 | 130 | 85  |
|   |   |  Puritan - 111209 | 225 | 150 | 18  |
|  Fusobacterium nucleatum ATCC 25586 | Diluted 10-3 | Puritan - 111101 | 199 | 105 | 26  |
|   |   |  Puritan - 110907 | 265 | 109 | 40  |
|   |   |  Puritan - 111209 | 213 | 281 | 33  |
|  Propionibacterium acnes ATCC 6919 | Diluted 10-4 | Puritan - 111101 | 280 | 161 | 57  |
|   |   |  Puritan - 110907 | 279 | 96 | 29  |
|   |   |  Puritan - 111209 | 202 | 196 | 65  |
|  Prevotella melaninogenica ATCC 25845 | Diluted 10-3 | Puritan - 111101 | 271 | 121 | 29  |
|   |   |  Puritan - 110907 | 264 | 96 | 21  |
|   |   |  Puritan - 111209 | 289 | 165 | 16  |
|  Neisseria gonorrhoeae ATCC 43069 | Diluted 10-4 | Puritan - 111101 | 264 | 150 |   |
|   |   |  Puritan - 110907 | 226 | 131 |   |
|   |   |  Puritan - 111209 | 258 | 158 |   |

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Table 2. Bacterial recovery results for the Roll-Plate Method at refrigerated temperature.

|  Organism | 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  |
| --- | --- | --- | --- | --- | --- |
|  Pseudomonas aeruginosa ATCC BAA-427 | Diluted 10-4 | Puritan - 111101 | 308 | 240 | 46  |
|   |   |  Puritan - 110907 | 241 | 113 | 54  |
|   |   |  Puritan - 111209 | 267 | 281 | 128  |
|  Streptococcus pyogenes ATCC 19615 | Diluted 10-4 | Puritan - 111101 | 250 | 200 | 41  |
|   |   |  Puritan - 110907 | 194 | 111 | 78  |
|   |   |  Puritan - 111209 | 245 | 102 | 81  |
|  Streptococcus pneumoniae ATCC 6305 | Diluted 10-4 | Puritan - 111101 | 134 | 61 | 16  |
|   |   |  Puritan - 110907 | 200 | 35 | 35  |
|   |   |  Puritan - 111209 | 171 | 122 | 59  |
|  Haemophilus influenzae ATCC 10211 | Diluted 10-4 | Puritan - 111101 | 264 | 134 | 45  |
|   |   |  Puritan - 110907 | 236 | 83 | 38  |
|   |   |  Puritan - 111209 | 250 | 136 | 47  |
|  Bacteroides fragilis ATCC 25285 | Diluted 10-3 | Puritan - 111101 | 320 | 220 | 52  |
|   |   |  Puritan - 110907 | 200 | 103 | 33  |
|   |   |  Puritan - 111209 | 270 | 230 | 96  |
|  Peptostreptococcus anaerobius ATCC 27337 | Diluted 10-3 | Puritan - 111101 | 265 | 101 | 49  |
|   |   |  Puritan - 110907 | 260 | 96 | 39  |
|   |   |  Puritan - 111209 | 225 | 158 | 10  |
|  Fusobacterium nucleatum ATCC 25586 | Diluted 10-3 | Puritan - 111101 | 199 | 85 | 14  |
|   |   |  Puritan - 110907 | 265 | 67 | 21  |
|   |   |  Puritan - 111209 | 213 | 181 | 41  |
|  Propionibacterium acnes ATCC 6919 | Diluted 10-4 | Puritan - 111101 | 280 | 186 | 23  |
|   |   |  Puritan - 110907 | 279 | 77 | 25  |
|   |   |  Puritan - 111209 | 202 | 164 | 108  |
|  Prevotella melaninogenica ATCC 25845 | Diluted 10-3 | Puritan - 111101 | 271 | 114 | 19  |
|   |   |  Puritan - 110907 | 264 | 121 | 16  |
|   |   |  Puritan - 111209 | 289 | 77 | 46  |
|  Neisseria gonorrhoeae ATCC 43069 | Diluted 10-4 | Puritan - 111101 | 264 | 119 |   |
|   |   |  Puritan - 110907 | 226 | 90 |   |
|   |   |  Puritan - 111209 | 258 | 160 |   |

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Table 3. Bacterial recovery results for the Swab Elution Method at room temperature.

|  Organism | 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 | Log10 Decline  |
| --- | --- | --- | --- | --- | --- | --- |
|  Pseudomonas aeruginosa ATCC BAA-427 | Diluted 10-4 | Puritan - 111101 | 1.0x106 | 1.2x106 | 2.1x105 | -0.68  |
|   |   |  Puritan - 110907 | 1.2x106 | 1.3x106 | 6.1x105 | -0.29  |
|   |   |  Puritan - 111209 | 2.7x106 | 1.9x106 | 1.8x106 | -0.18  |
|  Streptococcus pyogenes ATCC 19615 | Diluted 10-4 | Puritan - 111101 | 2.1x106 | 2.7x106 | 7.4x105 | -0.45  |
|   |   |  Puritan - 110907 | 2.6x106 | 9.1x105 | 3.5x105 | -0.87  |
|   |   |  Puritan - 111209 | 7.6x105 | 1.0x106 | 2.5x105 | -0.48  |
|  Streptococcus pneumoniae ATCC 6305 | Diluted 10-4 | Puritan - 111101 | 2.2x106 | 1.8x106 | 5.5x105 | -0.60  |
|   |   |  Puritan - 110907 | 1.4x106 | 8.8x105 | 3.1x105 | -0.65  |
|   |   |  Puritan - 111209 | 2.1x106 | 1.1x106 | 9.1x105 | -0.36  |
|  Haemophilus influenzae ATCC 10211 | Diluted 10-4 | Puritan - 111101 | 2.6x106 | 7.8x105 | 7.1x105 | -0.56  |
|   |   |  Puritan - 110907 | 2.1x106 | 1.4x106 | 5.1x105 | -0.61  |
|   |   |  Puritan - 111209 | 3.1x106 | 2.0x106 | 1.5x106 | -0.32  |
|  Bacteroides fragilis ATCC 25285 | Diluted 10-3 | Puritan - 111101 | 1.7x106 | 1.2x106 | 2.1x105 | -0.91  |
|   |   |  Puritan - 110907 | 9.9x105 | 5.4x105 | 2.8x105 | -0.55  |
|   |   |  Puritan - 111209 | 2.9x106 | 2.1x106 | 1.3x106 | -0.35  |
|  Peptostreptococcus anaerobius ATCC 27337 | Diluted 10-3 | Puritan - 111101 | 3.1x106 | 1.5x106 | 4.1x105 | -0.88  |
|   |   |  Puritan - 110907 | 2.0x106 | 1.3x106 | 4.2x105 | -0.68  |
|   |   |  Puritan - 111209 | 1.9x106 | 7.0x105 | 3.9x105 | -0.69  |
|  Fusobacterium nucleatum ATCC 25586 | Diluted 10-3 | Puritan - 111101 | 2.0x106 | 8.6x105 | 2.5x105 | -0.90  |
|   |   |  Puritan - 110907 | 1.9x106 | 7.8x105 | 2.1x105 | -0.96  |
|   |   |  Puritan - 111209 | 2.6x106 | 6.1x105 | 3.0x105 | -0.94  |
|  Propionibacterium acnes ATCC 6919 | Diluted 10-4 | Puritan - 111101 | 2.3x106 | 1.2x106 | 7.7x105 | -0.48  |
|   |   |  Puritan - 110907 | 2.0x106 | 9.9x105 | 6.2x105 | -0.51  |
|   |   |  Puritan - 111209 | 1.0x106 | 6.2x105 | 2.1x105 | -0.68  |
|  Prevotella melaninogenica ATCC 25845 | Diluted 10-3 | Puritan - 111101 | 1.8x106 | 8.9x105 | 5.6x105 | -0.51  |
|   |   |  Puritan - 110907 | 1.5x106 | 5.3x105 | 3.5x105 | -0.63  |
|   |   |  Puritan - 111209 | 1.9x106 | 4.2x105 | 1.7x105 | -1.05  |
|  Neisseria gonorrhoeae ATCC 43069 | Diluted 10-4 | Puritan - 111101 | 1.1x106 | 1.0x105 |  | -1.04  |
|   |   |  Puritan - 110907 | 9.9x105 | 4.6x105 |  | -0.33  |
|   |   |  Puritan - 111209 | 1.3x106 | 1.3x105 |  | -1.00  |

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Table 4. Bacterial recovery results for the Swab Elution Method at refrigerated temperature.

|  Organism | 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 | Log10Decline  |
| --- | --- | --- | --- | --- | --- | --- |
|  Pseudomonas aeruginosa ATCC BAA-427 | Diluted 10-4 | Puritan - 111101 | 1.0x106 | 9.5x105 | 5.0x105 | -0.30  |
|   |   |  Puritan - 110907 | 1.2x106 | 9.5x105 | 3.0x105 | -0.60  |
|   |   |  Puritan - 111209 | 2.7x106 | 4.3x105 | 8.8x105 | -0.49  |
|  Streptococcus pyogenes ATCC 19615 | Diluted 10-4 | Puritan - 111101 | 2.1x106 | 7.7x105 | 2.5x105 | -0.92  |
|   |   |  Puritan - 110907 | 2.6x106 | 5.0x105 | 2.3x105 | -1.05  |
|   |   |  Puritan - 111209 | 7.6x105 | 1.0x106 | 6.1x105 | -0.10  |
|  Streptococcus pneumoniae ATCC 6305 | Diluted 10-4 | Puritan - 111101 | 2.2x106 | 1.1x106 | 1.3x105 | -1.23  |
|   |   |  Puritan - 110907 | 1.4x106 | 6.8x105 | 1.3x105 | -1.03  |
|   |   |  Puritan - 111209 | 2.1x106 | 1.1x106 | 1.6x106 | -0.12  |
|  Haemophilus influenzae ATCC 10211 | Diluted 10-4 | Puritan - 111101 | 2.6x106 | 4.1x105 | 3.4x105 | -0.88  |
|   |   |  Puritan - 110907 | 2.1x106 | 1.0x106 | 2.0x105 | -1.02  |
|   |   |  Puritan - 111209 | 3.1x106 | 3.8x105 | 4.2x105 | -0.87  |
|  Bacteroides fragilis ATCC 25285 | Diluted 10-3 | Puritan - 111101 | 1.7x106 | 8.1x105 | 7.8x105 | -0.34  |
|   |   |  Puritan - 110907 | 9.9x105 | 6.1x105 | 2.0x105 | -0.69  |
|   |   |  Puritan - 111209 | 2.9x106 | 7.9x105 | 9.9x105 | -0.47  |
|  Peptostreptococcus anaerobius ATCC 27337 | Diluted 10-3 | Puritan - 111101 | 3.1x106 | 5.5x105 | 1.3x105 | -1.38  |
|   |   |  Puritan - 110907 | 2.0x106 | 7.7x105 | 1.5x105 | -1.12  |
|   |   |  Puritan - 111209 | 1.9x106 | 6.1x105 | 9.7x105 | -0.29  |
|  Fusobacterium nucleatum ATCC 25586 | Diluted 10-3 | Puritan - 111101 | 2.0x106 | 2.4x105 | 1.4x105 | -1.15  |
|   |   |  Puritan - 110907 | 1.9x106 | 3.0x105 | 1.8x105 | -1.02  |
|   |   |  Puritan - 111209 | 2.6x106 | 5.0x105 | 5.8x105 | -0.65  |
|  Propionibacterium acnes ATCC 6919 | Diluted 10-4 | Puritan - 111101 | 2.3x106 | 7.5x105 | 4.4x105 | -0.72  |
|   |   |  Puritan - 110907 | 2.0x106 | 4.6x105 | 4.9x105 | -0.61  |
|   |   |  Puritan - 111209 | 1.0x106 | 9.6x105 | 4.5x105 | -0.35  |
|  Prevotella melaninogenica ATCC 25845 | Diluted 10-3 | Puritan - 111101 | 1.8x106 | 3.0x105 | 3.2x105 | -0.75  |
|   |   |  Puritan - 110907 | 1.5x106 | 3.5x105 | 1.7x105 | -0.95  |
|   |   |  Puritan - 111209 | 1.9x106 | 3.0x105 | 1.2x105 | -1.20  |
|  Neisseria gonorrhoeae ATCC 43069 | Diluted 10-4 | Puritan - 111101 | 1.1x106 | 2.3x105 |  | -0.68  |
|   |   |  Puritan - 110907 | 9.9x105 | 6.7x105 |  | -0.17  |
|   |   |  Puritan - 111209 | 1.3x106 | 1.6x106 |  | -0.09  |

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a. Precision/Reproducibility: N/A

b. Linearity/assay reportable range: N/A

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

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 Liquid Amies Collection and Transport System. All samples tested were found to maintain pH within the specified range.

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

Sterilization: Puritan Liquid Amies Transport Systems are sterilized by gamma irradiation and validated following ANSI/AAMI/ISO 11137:2006, Sterilization of health care products - Radiation guidelines.

d. Detection limit: N/A

e. Analytical specificity: N/A

f. Assay cut-off: N/A

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. It is one component or an accessory to the bacterial identification process. Bench testing studies were done to determine the ability of the

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Puritan Amies liquid medium to maintain viability of different strains of aerobes, anaerobes and fastidious bacteria. It showed recovery of bacteria within the acceptance criteria recommended in the CLSI M40-A guidelines like the predicate device. (See above under Performance Characteristics)

b. Matrix comparison: N/A

3. Clinical studies:

a. Clinical Sensitivity: N/A
b. Clinical specificity: N/A
c. Other clinical supportive data (when a. and b. are not applicable): N/A

4. Clinical cut-off: N/A
5. Expected values/Reference range: N/A

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.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/LIO/K120846](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/LIO/K120846)

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