(575 days)
Not Found
No
The 510(k) summary describes a specimen collection and transport system. The device description and performance studies focus on the physical components (vial, swab, medium) and their ability to maintain bacterial viability. There is no mention of any software, algorithms, image processing, or data analysis that would suggest the use of AI or ML. The performance studies involve manual colony counting and standard microbiological procedures, not automated or intelligent analysis.
No
The device is intended for the collection and transport of clinical specimens for bacteriological examination and culture in a laboratory, not for treating any medical condition.
No
Explanation: The device is a 'Collection & Transport System' designed to maintain the viability of bacteria from clinical specimens during transport to a laboratory for bacteriological examination and culture. It does not perform the diagnostic examination itself, but rather provides the means to transport the sample for later diagnostic testing.
No
The device description clearly outlines physical components including a polypropylene screw-cap vial, Liquid Amies transport medium, and sterile peel-open pouches containing nylon flocked swabs. This indicates it is a hardware device with a chemical component (transport medium), not a software-only device.
Based on the provided information, the ARX Liquid Amies Collection & Transport System is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is specifically intended for the collection and transport of clinical specimens (nasal, lachrymal, auricular, urethral, rectal, vaginal, wound/abscess) from a patient to a laboratory for bacteriological examination and culture. This process is a key part of diagnosing infections, which falls under the scope of IVD devices.
- Device Description: The device contains a transport medium (Liquid Amies) designed to maintain the viability of bacteria in the collected specimens. This medium is crucial for the subsequent laboratory testing.
- Laboratory Processing: The specimens are explicitly stated to be processed in the laboratory using standard clinical laboratory operating procedures for bacterial culture. This confirms the device's role in the diagnostic workflow.
- Performance Studies: The performance studies described focus on the device's ability to maintain bacterial viability for subsequent laboratory testing, which is a critical performance characteristic for an IVD used in microbiology.
- Predicate Device: The mention of a predicate device (K120846 Puritan Liquid Amies Collection and Transport System) which is also a collection and transport system for microbiological specimens, further supports the classification of this device as an IVD.
In summary, the ARX Liquid Amies Collection & Transport System is designed to collect and preserve biological specimens for in vitro examination (bacteriological culture) to aid in the diagnosis of disease. This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ARX Liquid Amies Collection & Transport System (ARX) is intended for use in the collection of clinical specimens (i.e., nasal secretion/wash; lachrymal secretion/tears; auricular secretion/cerumen; urethral, rectal, or vaginal swab; wound/abscess material) potentially containing aerobic, and fastidious bacteria and their transport at 2-8°C or 25-30°C from the patient to the laboratory for bacteriological examination and culture. In the laboratory, the collected and transported clinical specimens of nasal, lachrymal, ceruminous, vaginal, urethral, rectal, and wound/abscess origin are processed using standard clinical laboratory operating procedures for bacterial culture.
Product codes (comma separated list FDA assigned to the subject device)
LIO, JTW, JTX
Device Description
The ARX Liquid Amies Collection & Transport System consists of a polypropylene screw-cap vial containing Liquid Amies transport medium and three (3) sterile peel-open pouches containing a pre-scored Microbrush nylon flocked swab for collecting specimens. The three (3) nylon flocked swabs are provided with various score points, tip sizes, and configurations to facilitate specimen collection from various sites on patients' bodies. Nylon flocked swabs facilitate quick absorption and release of clinical specimens. Proper specimen collection from the patient is critical for successful isolation and identification of infectious organisms.
Amies liquid medium is a non-nutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, and magnesium chloride to provide essential ions that help maintain osmotic balance and control permeability of bacterial cells. It also contains sodium thioglycolate to provide a reduced environment. ARX Liquid Amies transport medium is capable of maintaining the viability of aerobic, anaerobic, and fastidious bacteria (such as Neisseria gonorrhoeae) during specimen transport to the laboratory for bacteriological testing and culture.
All raw materials used in the manufacture of ARX Liquid Amies Collection & Transport System are qualified before use. Every batch of ARX Liquid Amies Collection & Transport System is tested prior to release for sterility, pH, and background count using microscopic examination. Representative samples of each batch are further evaluated for their ability to maintain the viability of selected bacterial agents over predefined time periods.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal secretion/wash; lachrymal secretion/tears; auricular secretion/cerumen; urethral, rectal, or vaginal swab; wound/abscess material
Indicated Patient Age Range
Not Found
Intended User / Care Setting
From the patient to the laboratory for bacteriological examination and culture. In the laboratory, the collected and transported clinical specimens... are processed using standard clinical laboratory operating procedures for bacterial culture.
For Prescription Use (Rx) Only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance of ARX Liquid Amies Collection & Transport System for bacterial recovery was determined using roll plate and swab elution methods, following the FDA-recognized sections of Clinical Laboratory Standards Institute (CLSI) M40-A2:2014 Quality Control of Microbiological Transport Systems: Approved Standard - Second Edition. A total of three (3) aerobic, six (6) facultative anaerobic (including one (1) fastidious organism), and eight (8) obligate anaerobic bacteria was included in the bacterial recovery studies. For dilution of the inoculum, a subset of these organisms was tested in the presence of NCM or sterile saline (in a separate set where negative clinical matrix was omitted), whereas another subset of the organisms used saline only. The data indicated no impact on performance for the most challenging organisms when diluted in either matrix or saline. Additionally, justification was provided to support the claim that the subset of organisms tested in saline is expected to have equivalent performance in the presence of matrix.
Performance was assessed using the Roll-Plate and Swab Elution methods. Manual colony counts were conducted for both at all time intervals for each swab-organism combination, and the mean count was recorded per anatomical site. Three (3) dilutions were analyzed for each test organism and the dilution yielding colony counts nearest 300 CFU at time zero was reported and/or used for mean CFU/mL estimations, following the recommendations of CLSI M40-A2 (sections 8.12.1, 8.12.3, and 8.12.4 for Roll-Plate studies: sections 8.11.1. 8.11.2. 8.11.4 for Swab Elution studies). Acceptance criteria for bacterial recovery (minimum acceptable viability of at least 2% CFU relative to time 0 for Roll-plate studies; maximum 3 log10 decline in CFU acceptable relative to time 0 for Swab Elution studies) were followed as recommended in CLSI M40-A2. The performance of all bacterial recovery, when used with or without NCM, was found to be acceptable.
Roll-Plate Method Studies:
Bacterial suspensions were prepared to approximately 0.5 McFarland in NCM or sterile saline. The performance was determined using procedures outlined in CLSI M40-A2 using three sterile flocked swab types (NPS, nasopharyngeal swab, with or without tapered tip design; OPS, oropharyngeal swab). The studies were conducted at two different temperatures: refrigerated (2–8°C) and room temperature (25-30°C or 20-25°C). Three (3) independent lots of ARX Liquid Amies were used: old (post-production age at study: 23-24 months or 17 months), middle-aged (age: 6-7 months), and newly manufactured (age: 1-2 months or 2 months). Swabs from each transport system were inoculated in triplicate with specified volume of select bacterial suspensions, placed in their respective transport vial, and held for 0, 24, and 48 hours (except Neisseria gonorrhoeae held only for 24 hours). Bacterial CFU counts were recovered at designated time intervals.
Swab Elution Method Studies:
Bacterial suspensions were prepared in NCM or sterile saline similar to the roll-plate method. Performance characteristics were determined using procedures outlined in CLSI M40-A2 and three sterile flocked swab types (NPS, OPS). Studies were conducted at refrigerated (2–8°C) and room temperature (25–30°C or 20-25°C) conditions. Three (3) independent lots of ARX Liquid Amies were used (same age categories as roll-plate studies). Swabs were inoculated in triplicate, placed in transport vials, and held for 0, 24, and 48 hours (except Neisseria gonorrhoeae held only for 24 hours). Bacterial CFU/mL counts were recovered at designated time intervals.
Shelf-life Stability Studies:
Additional studies were conducted with four (4) manufactured lots of ARX Liquid Amies Collection & Transport System for the evaluation of shelf-life stability at room temperature (20–25°C) in real time. Tests included:
(a) pH monitoring: Monthly, random tubes from independent lots maintained pH within 7.30 ± 0.2 from time zero through 18 months.
(b) Visual estimation of turbidity: Monthly, random tubes from independent lots passed visual inspection from time zero through 18 months.
(c) Viscosity measurement: Every 4 months, random tubes from independent lots maintained viscosity within 1.075 ± 0.015 milliPascal.Second from time zero through 18 months.
Key Results: The ARX Liquid Amies Collection & Transport System showed recovery of bacteria within the acceptance criteria comparable to the predicate device for all holding temperatures tested. This demonstrates the acceptability claim of up to 48 hours for all organisms (except 24 hours for Neisseria gonorrhoeae) in clinical samples during storage and/or transport in this transport system. Additional studies conducted support the shelf-life stability claim of 18 months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Acceptance criteria for bacterial recovery:
- Minimum acceptable viability of at least 2% CFU relative to time 0 for Roll-plate studies.
- Maximum 3 log10 decline in CFU acceptable relative to time 0 for Swab Elution studies.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.2900 Microbiological specimen collection and transport device.
(a)
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.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
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March 27, 2024
ARX Sciences, Inc. Chad Werts President 160 Lawrence Bell Drive Suite 120 Amherst, New York 14221
Re: K222613
Trade/Device Name: ARX Liquid Amies Collection & Transport System Regulation Number: 21 CFR 866.2900 Regulation Name: Microbiological Specimen Collection And Transport Device Regulatory Class: Class I, reserved Product Code: LIO, JTW, JTX Dated: March 31, 2023 Received: March 31, 2023
Dear Chad Werts:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Branch Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222613
Device Name
ARX Liquid Amies Collection and Transport System
Indications for Use (Describe)
The ARX Liquid Amies Collection & Transport System (ARX) is intended for use in the collection of clinical specimens (i.e., nasal secretion/wash; lachrymal secretion/tears; auricular secretion/cerumen; urethral, rectal, or vaginal swab; wound/abscess material) potentially containing aerobic, and fastidious bacteria and their transport at 2-8°C or 25-30°C from the patient to the laboratory for bacteriological examination and culture. In the laboratory, the collected and transported clinical specimens of nasal, lachrymal, ceruminous, vaginal, urethral, rectal, and wound/abscess origin are processed using standard clinical laboratory operating procedures for bacterial culture.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
March 12th, 2024
Sponsored by:
ARX Sciences. Inc. 160 Lawrence Bell Drive, Suite 120 Amherst, NY 14221 Contact: Chad Werts Telephone Number: (914) 821-1775
Device Name
| Classification Name: | Microbiology Devices |
|---|---|
| Common Name: | Microbiological Specimen Collection and Transport Device |
| Proprietary Name: | ARX Liquid Amies Collection & Transport System |
| Regulation Section: | 21 CFR 866.2900 |
| Classification: | Microbiological specimen collection and transport device |
| Class I | |
| Product Codes: | LIO: Device, Specimen Collection |
| JTW: System, Transport, Aerobic | |
| JTX: Transport Systems, Anaerobic | |
| Predicate Device: | K120846 Transport Culture Medium Device |
| Puritan Medical Products LLC. |
Device Description:
The ARX Liquid Amies Collection & Transport System consists of a polypropylene screw-cap vial containing Liquid Amies transport medium and three (3) sterile peel-open pouches containing a pre-scored Microbrush nylon flocked swab for collecting specimens. The three (3) nylon flocked swabs are provided with various score points, tip sizes, and configurations to facilitate specimen collection from various sites on patients' bodies. Nylon flocked swabs facilitate quick absorption and release of clinical specimens. Proper specimen collection from the patient is critical for successful isolation and identification of infectious organisms.
Amies liquid medium is a non-nutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, and magnesium chloride to provide essential ions that help maintain osmotic balance and control permeability of bacterial cells. It also contains sodium thioglycolate to provide a reduced environment. ARX Liquid Amies transport medium is capable of maintaining the viability of aerobic, anaerobic, and fastidious bacteria (such as Neisseria gonorrhoeae) during specimen transport to the laboratory for bacteriological testing and culture.
All raw materials used in the manufacture of ARX Liquid Amies Collection & Transport System are qualified before use. Every batch of ARX Liquid Amies Collection & Transport System is tested prior to release for sterility, pH, and background count using microscopic examination. Representative samples of each batch are further evaluated for their ability to maintain the viability of selected bacterial agents over predefined time periods.
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Once a specimen is collected with a swab and added to the transport medium vial, it is immediately processed to achieve optimal recovery. For cases where immediate processing (i.e., within 2 hours) is not possible, specimens are stored at 2-30°C and processed within 48 hours (except for Neisseria gonorrhoeae, which should be processed within 24 hours).
Intended Use / Indications of Use
The ARX Liquid Amies Collection & Transport System (ARX) is intended for use in the collection of clinical specimens (i.e., nasal secretion/tears: auricular secretion/cerumen: urethral. rectal, or vaginal swab; wound/abscess material) potentially containing aerobic, and fastidious bacteria and their transport at 2-8°C or 25-30°C from the patient to the laboratory for bacteriological examination and culture. In the laboratory, the collected and transported clinical specimens of nasal, lachrymal, ceruminous, vaginal, urethral, rectal, and wound/abscess origin are processed using standard clinical laboratory operating procedures for bacterial culture. Special Conditions for Use: ARX Liquid Amies Collection & Transport System is intended For Prescription Use (Rx) Only,
| Device & Predicate
| Device(s): | Device: K222613 | Predicate: K120846 |
|---|---|---|
| Device Trade Name | ARX Liquid Amies Collection & Transport | |
| System | Puritan Liquid Amies | |
| Collection and | ||
| Transport System | ||
| General Device | ||
| Characteristic Similarities | ||
| Intended Use/Indications For | ||
| Use | The ARX Liquid Amies Collection & | |
| Transport System (ARX) is intended for use | ||
| in the collection of clinical specimens (i.e., | ||
| nasal secretion/wash; lachrymal | ||
| secretion/tears; auricular secretion/cerumen; | ||
| urethral, rectal, or vaginal swab; | ||
| wound/abscess material) potentially | ||
| containing aerobic, anaerobic, and | ||
| fastidious bacteria and their transport at 2- | ||
| 8°C or 25-30°C from the patient to the | ||
| laboratory for bacteriological examination | ||
| and culture. In the laboratory, the collected | ||
| and transported clinical specimens of nasal, | ||
| lachrymal, ceruminous, vaginal, urethral, | ||
| rectal, and wound/abscess origin are | ||
| processed using standard clinical laboratory | ||
| operating procedures for bacterial culture. | Puritan Liquid Amies | |
| Collection and | ||
| Transport System is | ||
| intended for use in the | ||
| collection and | ||
| transport of clinical | ||
| specimens containing | ||
| aerobic, anaerobic | ||
| and fastidious | ||
| bacteria from the | ||
| patient to the | ||
| laboratory for | ||
| bacteriological | ||
| examination and | ||
| culture. | ||
| Product Code | LIO, JTW, JTX | SAME |
| Use/Reuse information | Single Use Device (SUD) | SAME |
| Product Configuration | Base Transport Medium in a screw-capped, | |
| conical-bottom tube; specimen collection | ||
| swabs individually in sterile peel pouches | SAME | |
| Base Transport Medium | Modified Liquid Amies | SAME |
Comparison to Predicate Device Technological Characteristics (Table 1):
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| Device & Predicate
| Device(s): | Device: K222613 | Predicate: K120846 |
|---|---|---|
| Transport Medium tube / | ||
| volume | Plastic (polypropylene) / 1 mL | SAME |
| Swab shaft | Plastic, pre-scored | SAME |
| Amies Formulation | Sodium chloride | |
| Disodium phosphate | ||
| Sodium thioglycolate | ||
| Monopotassium phosphate | ||
| Potassium chloride | ||
| Calcium chloride | ||
| Magnesium chloride | SAME | |
| pH | 7.3 ± 0.2 (range 7.1-7.5) | SAME |
| Product Storage temperature | ||
| (refrigerated and room) | 2-8°C, 20-25°C | SAME |
| Shelf life | 18 months | SAME |
| General Device | ||
| Characteristic Differences | ||
| Kit configuration | Medium tubes (50 count) in a kit box with | |
| blister peel pouches (50 count) with swabs | ||
| inside | Single peel pouch | |
| containing sterile | ||
| swab and Medium | ||
| tube | ||
| Swab tip | Microbrush Nylon Flocked Swab | HydraFlock Swab |
| (Polyester) |
Performance Characteristics
Performance of ARX Liquid Amies Collection & Transport System for bacterial recovery was determined using roll plate and swab elution methods, following the FDA-recognized sections of Clinical Laboratory Standards Institute (CLSI) M40-A2:2014 Quality Control of Microbiological Transport Systems: Approved Standard - Second Edition. As shown in Table 2, a total of three (3) aerobic, six (6) facultative anaerobic (including one (1) fastidious organism), and eight (8) obligate anaerobic bacteria was included in the bacterial recovery studies. Additionally, Table 2 also lists the appropriate Negative Clinical Matrix (NCM) that was used in all these studies. For dilution of the inoculum, a subset of these organisms was tested in the presence of NCM or sterile saline (in a separate set where negative clinical matrix was omitted), whereas another subset of the organisms used saline only. The data indicated no impact on performance for the most challenging organisms when diluted in either matrix or saline. Additionally, justification was provided to support the claim that the subset of organisms tested in saline is expected to have equivalent performance in the presence of matrix.
Performance was assessed using the Roll-Plate and Swab Elution methods. Manual colony counts were conducted for both at all time intervals for each swab-organism combination, and the mean count was recorded per anatomical site. Three (3) dilutions were analyzed for each test organism and the dilution yielding colony counts nearest 300 CFU at time zero was reported and/or used for mean CFU/mL estimations, following the recommendations of CLSI M40-A2 (sections 8.12.1, 8.12.3, and 8.12.4 for Roll-Plate studies: sections 8.11.1. 8.11.2. 8.11.4 for Swab Elution studies). Acceptance criteria for bacterial recovery (minimum acceptable viability of at least 2% CFU relative to time 0 for Roll-plate studies; maximum 3 logio decline in CFU acceptable relative to time 0 for Swab Elution studies) were followed as recommended in CLSI M40-A2. As discussed in the respective sections below and shown in Tables 3–10
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below, the performance of all bacterial recovery, when used with or without NCM, was found to be acceptable.
| Table 2: Bacterial strains used for Roll-Plate and Swab Elution studies in Negative Clinical Matrix | |||
|---|---|---|---|
| (NCM) or Saline |
| Bacteria (ATCC
Part #) | Characteristic | 0.5 McFarland
suspension
diluted with | | Matrix (Swab Types: NPS,
nasopharyngeal, including
tapered tip type; OPS,
oropharyngeal) | |
|----------------------------------------------------------------|----------------------------------------|---------------------------------------------|--------|---------------------------------------------------------------------------------------------------|--------|
| | | NCM | Saline | NCM | Saline |
| Haemophilus
influenzae (ATCC
10211) | Facultative
anaerobe | 10-4 | 10-4 | Nasal
Irrigation/Wash
(NPS & OPS) | (NPS) |
| Streptococcus
pneumoniae
(ATCC 6305) | Facultative
anaerobe | 10-4 | 10-4 | Nasal
Irrigation/Wash
(NPS & OPS) | (NPS) |
| Staphylococcus
aureus (MRSA)
(ATCC 43300) | Aerobe | 10-4 | 10-4 | Tears, Pooled
Human Donors
(NPS) | (NPS) |
| Pseudomonas
aeruginosa (ATCC
BAA-427) | Aerobe | 10-4 | 10-4 | Auricular
material/cerumen
(NPS) | (NPS) |
| Streptococcus
agalactiae (Group
B Strep) (ATCC
13813) | Aerobe | 10-4 | 10-4 | Vaginal & Rectal
Swab (NPS & OPS) | (NPS) |
| Neisseria
gonorrhoeae
(ATCC 43069) | Fastidious,
facultative
Anaerobe | 10-4 | 10-4 | Vaginal Swab (NPS
& OPS); Urethral
Swab (NPS) | (NPS) |
| Bacteroides fragilis
(ATCC 25285) | Anaerobe | 10-3 | 10-3 | Wound/Abscess
(NPS & OPS) | (NPS) |
| Fusobacterium
nucleatum (ATCC
25586) | Anaerobe | 10-3 | 10-3 | Wound/Abscess
(NPS & OPS) | (NPS) |
| Streptococcus
pyogenes (ATCC
19615) | Facultative
anaerobe | | 10-4 | | (NPS) |
| Propionibacterium
acnes (ATCC
6919) | Facultative
anaerobe | | 10-5 | | (NPS) |
| Enterococcus
faecalis (ATCC
51299) | Facultative
anaerobe | | 10-4 | | (NPS) |
| Peptostreptococcus
anaerobius (ATCC
27337) | Anaerobe | | 10-3 | | (NPS) |
| Prevotella
melaninogenica
(ATCC 25845) | Anaerobe | | 10-5 | | (NPS) |
| Bacteria (ATCC
Part #) | Characteristic | 0.5 McFarland
suspension
diluted with | | Matrix (Swab Types: NPS,
nasopharyngeal, including
tapered tip type; OPS,
oropharyngeal) | |
| | | NCM | Saline | NCM | Saline |
| Clostridium
perfringens (Strain
S 107) (ATCC
13124) | Anaerobe | | 10-4 | | (NPS) |
| Clostridium
sporogenes (ATCC
3584) | Anaerobe | | 10-4 | | (NPS) |
| Finegoldia magna
(Strain WAL2508)
(ATCC 29328) | Anaerobe | | 10-4 | | (NPS) |
| Fusobacterium
necrophorum
(ATCC 25286) | Anaerobe | | 10-4 | | (NPS) |
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Image /page/7/Picture/1 description: The image shows a logo for ARX SCIENCES. The logo is a stylized letter "A" in blue, with two red shapes inside the "A". The text "ARX SCIENCES" is written in black below the logo. The background is white.
Roll-Plate Method:
For the roll-plate method, bacterial suspensions were prepared to approximately 0.5 McFarland in NCM (as indicated in Table 2) followed by 10-fold serial dilutions in pooled NCM. The performance characteristics of ARX Liquid Amies Collection & Transport System were determined using procedures outlined in CLSI M40-A2 using three sterile flocked swab types (i.e., NPS, nasopharyngeal swab, with or without tapered tip design; OPS, oropharyngeal swab) designed for throat, urogenital and nasal specimen collection. This study was conducted at two different temperatures to reflect refrigerated (2–8°C) and room temperature (25-30°C) conditions in NCM and used three (3) independent lots of ARX Liquid Amies representing old (Lot #A030921, post-production age at study: 23-24 months), middle-aged (Lot #AR1002, age: 6-7 months), and newly manufactured (Lot #A1229222, age: 1-2 months) lots. The swabs from each transport system were inoculated in triplicate with a specified volume of select bacterial suspensions prepared in NCM. These swabs were then placed in their respective transport vial and held for 0, 24, and 48 hrs. (except Neisseria gonorrhoeae held only for 24 hrs.); at the designated time intervals the swabs were removed and processed for recovery of bacterial CFU counts (refer to Table 4).
Additional set of roll-plate testing was performed using 0.5 McFarland suspensions prepared and serially diluted in sterile saline to the desired concentration (as shown in Table 2). The performance characteristics of ARX Liguid Amies Collection & Transport System in saline were determined as above using the two NPS types. This study was conducted at two different temperatures to reflect refrigerated (2-8°C) and room temperature (20–25°C) conditions in saline, along with the additional bacterial strains (as indicated in Table 2), and used three (3) independent lots of ARX Liquid Amies representing old (Lot #A030921; post-production age at study: 17 months), middle-aged (Lot #AR1001/2/3, age:6-7 months), and newly manufactured (Lot #A061422, age: 2 months) lots. The swabs from each transport system were inoculated in triplicate with a specified volume of select bacterial suspensions prepared in sterile saline, placed in their respective transport vials, and held for 0, 24, and 48 hrs. (except Neisseria gonorrhoeae held only for 24 hrs.); at the designated time intervals the swabs were removed and processed for recovery of bacterial CFU counts (refer to Table 5 and Table 6).
Table 3: Roll-Plate Method of Bacterial Recovery following Storage at Refrigerated (2-8°C) Conditions using NCM.
8
Image /page/8/Picture/1 description: The image features a logo for "ARX SCIENCES". The logo is a stylized letter "A" in dark blue, with two red bars inside the "A". Below the logo, the words "ARX SCIENCES" are written in a simple, sans-serif font, also in dark blue. The overall design is clean and modern, suggesting a company focused on science or technology.
| Organism
(ATCC Part #) | Lot
Age | Average
CFUs
Recovered:
Time 0 hr. | Average
CFUs
Recovered:
Time 24 hrs. | Average
CFUs
Recovered:
Time 48 hrs. |
|-------------------------------------------------------------|------------|---------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| Haemophilus
influenzae (ATCC
10211) | Old | 219 | 186 | 87 |
| Haemophilus
influenzae (ATCC
10211) | Middle | 226 | 191 | 93 |
| Haemophilus
influenzae (ATCC
10211) | New | 223 | 191 | 91 |
| Streptococcus
pneumoniae (ATCC
6305) | Old | 259 | 226 | 110 |
| Streptococcus
pneumoniae (ATCC
6305) | Middle | 254 | 223 | 109 |
| Streptococcus
pneumoniae (ATCC
6305) | New | 261 | 228 | 113 |
| Staphylococcus
aureus (MRSA)
(ATCC 43300) | Old | 228 | 140 | 77 |
| Staphylococcus
aureus (MRSA)
(ATCC 43300) | Middle | 242 | 135 | 72 |
| Staphylococcus
aureus (MRSA)
(ATCC 43300) | New | 247 | 145 | 79 |
| Pseudomonas
aeruginosa (ATCC
BAA-427) | Old | 268 | 256 | 119 |
| Pseudomonas
aeruginosa (ATCC
BAA-427) | Middle | 276 | 258 | 128 |
| Pseudomonas
aeruginosa (ATCC
BAA-427) | New | 290 | 269 | 124 |
| Neisseria
gonorrhoeae (ATCC
43069) | Old | 267 | 136 | |
| Neisseria
gonorrhoeae (ATCC
43069) | Middle | 269 | 138 | |
| Neisseria
gonorrhoeae (ATCC
43069) | New | 281 | 146 | |
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | Old | 275 | 134 | 53 |
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | Middle | 276 | 132 | 56 |
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | New | 281 | 136 | 55 |
| Bacteroides fragilis
(ATCC 25285) | Old | 258 | 181 | 73 |
| Bacteroides fragilis
(ATCC 25285) | Middle | 258 | 183 | 79 |
| Bacteroides fragilis
(ATCC 25285) | New | 261 | 185 | 81 |
| Fusobacterium
nucleatum (ATCC
25586) | Old | 223 | 156 | 32 |
| Fusobacterium
nucleatum (ATCC
25586) | Middle | 228 | 165 | 37 |
| Fusobacterium
nucleatum (ATCC
25586) | New | 233 | 166 | 40 |
- Neisseria gonorrhoeae recovery tested only at 24 hrs.
| Table 4: Roll-Plate Method of Bacterial Recovery following Storage at Room Temperature (25–30°C) | ||
|---|---|---|
| Conditions using NCM. |
| Organism
(ATCC Part #) | Lot
Age | Average
CFUs
Recovered:
Time 0 hr. | Average
CFUs
Recovered:
Time 24 hrs. | Average
CFUs
Recovered:
Time 48 hrs. |
|-------------------------------------------------|------------|---------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| Haemophilus | Old | 216 | 170 | 64 |
| influenzae (ATCC | Middle | 218 | 163 | 63 |
| 10211) | New | 225 | 176 | 72 |
| Streptococcus | Old | 218 | 144 | 63 |
| pneumoniae (ATCC
6305) | Middle | 229 | 149 | 62 |
| pneumoniae (ATCC
6305) | New | 233 | 148 | 63 |
| Staphylococcus
aureus (MRSA)
(ATCC 43300) | Old | 243 | 135 | 59 |
| Staphylococcus
aureus (MRSA)
(ATCC 43300) | Middle | 239 | 143 | 67 |
| Staphylococcus
aureus (MRSA)
(ATCC 43300) | New | 249 | 145 | 69 |
| Pseudomonas
aeruginosa (ATCC | Old | 286 | 234 | 106 |
| Pseudomonas
aeruginosa (ATCC | Middle | 287 | 236 | 105 |
| BAA-427) | New | 293 | 246 | 106 |
| | Old | 251 | 137 | |
9
Image /page/9/Picture/1 description: The image shows a logo for ARX SCIENCES. The logo is a stylized letter "A" in blue, with two red shapes inside the "A". The text "ARX SCIENCES" is written in black below the logo. The logo is simple and modern, and the colors are eye-catching.
| Organism
(ATCC Part #) | Lot
Age | Average
CFUs
Recovered:
Time 0 hr. | Average
CFUs
Recovered:
Time 24 hrs. | Average
CFUs
Recovered:
Time 48 hrs. |
|-------------------------------------------------------------|------------|---------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| Neisseria
gonorrhoeae (ATCC
43069) | Middle | 266 | 142 | |
| Neisseria
gonorrhoeae (ATCC
43069) | New | 262 | 142 | |
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | Old | 285 | 118 | 52 |
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | Middle | 290 | 123 | 52 |
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | New | 287 | 117 | 52 |
| Bacteroides fragilis
(ATCC 25285) | Old | 281 | 177 | 92 |
| Bacteroides fragilis
(ATCC 25285) | Middle | 276 | 175 | 89 |
| Bacteroides fragilis
(ATCC 25285) | New | 278 | 181 | 97 |
| Fusobacterium
nucleatum (ATCC
25586) | Old | 204 | 150 | 40 |
| Fusobacterium
nucleatum (ATCC
25586) | Middle | 214 | 153 | 37 |
| Fusobacterium
nucleatum (ATCC
25586) | New | 222 | 151 | 43 |
- Neisseria gonorrhoeae recovery tested only at 24 hrs.
Table 5: Roll-Plate Method of Bacterial Recovery following Storage at Refrigerated (2–8°C) Conditions using Saline.
| Organism
(ATCC Part #) | Lot
Age | Average
CFUs
Recovered:
Time 0 hr. | Average
CFUs
Recovered:
Time 24 hrs. | Average
CFUs
Recovered:
Time 48 hrs. |
|------------------------------------------------------------|------------|---------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| Streptococcus
pyogenes (ATCC
19615) | Old | 249 | 247 | 135 |
| Streptococcus
pyogenes (ATCC
19615) | Middle | 239 | 177 | 105 |
| Streptococcus
pyogenes (ATCC
19615) | New | 195 | 199 | 94 |
| Peptostreptococcus
anaerobius (ATCC
27337) | Old | 215 | 163 | 38 |
| Peptostreptococcus
anaerobius (ATCC
27337) | Middle | 261 | 180 | 32 |
| Peptostreptococcus
anaerobius (ATCC
27337) | New | 214 | 144 | 37 |
| Propionibacterium
acnes (ATCC 6919) | Old | 257 | 163 | 42 |
| Propionibacterium
acnes (ATCC 6919) | Middle | 275 | 159 | 37 |
| Propionibacterium
acnes (ATCC 6919) | New | 230 | 137 | 34 |
| Prevotella
melaninogenica
(ATCC 25845) | Old | 259 | 121 | 27 |
| Prevotella
melaninogenica
(ATCC 25845) | Middle | 247 | 126 | 34 |
| Prevotella
melaninogenica
(ATCC 25845) | New | 260 | 119 | 33 |
| Enterococcus
faecalis (ATCC
51299) | Old | 236 | 114 | 38 |
| Enterococcus
faecalis (ATCC
51299) | Middle | 252 | 108 | 35 |
| Enterococcus
faecalis (ATCC
51299) | New | 237 | 113 | 43 |
| Clostridium
perfringens (Strain S-
107) (ATCC 13124) | Old | 280 | 146 | 44 |
| Clostridium
perfringens (Strain S-
107) (ATCC 13124) | Middle | 288 | 161 | 51 |
| Clostridium
perfringens (Strain S-
107) (ATCC 13124) | New | 289 | 158 | 42 |
| Clostridium
sporogenes (ATCC
3584) | Old | 245 | 97 | 39 |
| Clostridium
sporogenes (ATCC
3584) | Middle | 251 | 93 | 38 |
| Clostridium
sporogenes (ATCC
3584) | New | 238 | 97 | 34 |
| Finegoldia magna
(Strain WAL2508)
(ATCC 29328) | Old | 273 | 150 | 48 |
| Finegoldia magna
(Strain WAL2508)
(ATCC 29328) | Middle | 280 | 142 | 44 |
| Finegoldia magna
(Strain WAL2508)
(ATCC 29328) | New | 274 | 143 | 52 |
| Finegoldia magna
(Strain WAL2508)
(ATCC 29328) | Old | 283 | 144 | 56 |
10
Image /page/10/Picture/1 description: The image shows a logo for ARX Sciences. The logo is a stylized letter "A" in blue, with two red bars inside the "A". The text "ARX SCIENCES" is written in black below the logo. The logo is simple and modern, and the colors are eye-catching.
| Organism
(ATCC Part #) | Lot
Age | Average
CFUs
Recovered:
Time 0 hr. | Average
CFUs
Recovered:
Time 24 hrs. | Average
CFUs
Recovered:
Time 48 hrs. |
|-----------------------------|------------|---------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| Fusobacterium | Middle | 288 | 146 | 51 |
| necrophorum (ATCC
25286) | New | 275 | 150 | 53 |
| Pseudomonas | Old | 305 | 270 | 95 |
| aeruginosa (ATCC | Middle | 284 | 241 | 92 |
| BAA-427) | New | 299 | 274 | 86 |
| Streptococcus | Old | 253 | 230 | 110 |
| pneumoniae (ATCC | Middle | 246 | 216 | 85 |
| 6305) | New | 214 | 171 | 68 |
| Haemophilus | Old | 210 | 184 | 88 |
| influenzae (ATCC | Middle | 229 | 195 | 74 |
| 10211) | New | 223 | 189 | 73 |
| Bacteroides fragilis | Old | 302 | 215 | 107 |
| (ATCC 25285) | Middle | 247 | 181 | 82 |
| | New | 273 | 192 | 99 |
| Fusobacterium | Old | 232 | 160 | 32 |
| nucleatum (ATCC | Middle | 237 | 156 | 31 |
| 25586) | New | 212 | 136 | 26 |
| Neisseria | Old | 273 | 120 | |
| gonorrhoeae (ATCC | Middle | 267 | 133 | |
| 43069) | New | 268 | 130 | |
| Staphylococcus | Old | 255 | 145 | 76 |
| aureus (MRSA) | Middle | 249 | 131 | 61 |
| (ATCC 43300) | New | 254 | 126 | 63 |
| Streptococcus | Old | 299 | 128 | 50 |
| agalactiae (Group B | Middle | 292 | 122 | 47 |
| Strep) (ATCC 13813) | New | 307 | 128 | 53 |
- Neisseria gonorrhoeae recovery tested only at 24 hrs.
Table 6: Roll-Plate Method of Bacterial Recovery following Storage at Room Temperature (20–25°C) Conditions using Saline.
| Organism
(ATCC Part #) | Lot
Age | Average
CFUs
Recovered:
Time 0 hr. | Average
CFUs
Recovered:
Time 24 hrs. | Average
CFUs
Recovered:
Time 48 hrs. |
|-------------------------------------------------------------|------------|---------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| Streptococcus
pyogenes (ATCC
19615) | Old | 254 | 227 | 120 |
| Streptococcus
pyogenes (ATCC
19615) | Middle | 230 | 177 | 98 |
| Streptococcus
pyogenes (ATCC
19615) | New | 199 | 193 | 84 |
| Peptostreptococcus
anaerobius (ATCC
27337) | Old | 223 | 150 | 32 |
| Peptostreptococcus
anaerobius (ATCC
27337) | Middle | 248 | 176 | 40 |
| Peptostreptococcus
anaerobius (ATCC
27337) | New | 220 | 140 | 29 |
| Propionibacterium
acnes (ATCC 6919) | Old | 253 | 163 | 44 |
| Propionibacterium
acnes (ATCC 6919) | Middle | 258 | 157 | 38 |
| Propionibacterium
acnes (ATCC 6919) | New | 225 | 128 | 31 |
| | Old | 261 | 122 | 31 |
| Organism
(ATCC Part #) | Lot Age | Average CFUs
Recovered:
Time 0 hr. | Average CFUs
Recovered:
Time 24 hrs. | Average CFUs
Recovered:
Time 48 hrs. |
| Prevotella
melaninogenica
(ATCC 25845) | Middle | 252 | 119 | 39 |
| Prevotella
melaninogenica
(ATCC 25845) | New | 268 | 127 | 44 |
| Enterococcus
faecalis (ATCC
51299) | Old | 238 | 119 | 39 |
| Enterococcus
faecalis (ATCC
51299) | Middle | 259 | 107 | 43 |
| Enterococcus
faecalis (ATCC
51299) | New | 241 | 112 | 37 |
| Clostridium
perfringens (Strain S-
107) (ATCC 13124) | Old | 276 | 152 | 48 |
| Clostridium
perfringens (Strain S-
107) (ATCC 13124) | Middle | 283 | 164 | 53 |
| Clostridium
perfringens (Strain S-
107) (ATCC 13124) | New | 280 | 159 | 56 |
| Clostridium
sporogenes (ATCC
3584) | Old | 253 | 106 | 45 |
| Clostridium
sporogenes (ATCC
3584) | Middle | 244 | 97 | 42 |
| Clostridium
sporogenes (ATCC
3584) | New | 236 | 92 | 37 |
| Finegoldia magna
(Strain WAL2508)
(ATCC 29328) | Old | 183 | 124 | 67 |
| Finegoldia magna
(Strain WAL2508)
(ATCC 29328) | Middle | 173 | 122 | 64 |
| Finegoldia magna
(Strain WAL2508)
(ATCC 29328) | New | 187 | 127 | 62 |
| Fusobacterium
necrophorum (ATCC
25286) | Old | 273 | 136 | 39 |
| Fusobacterium
necrophorum (ATCC
25286) | Middle | 281 | 142 | 32 |
| Fusobacterium
necrophorum (ATCC
25286) | New | 279 | 140 | 42 |
| Pseudomonas
aeruginosa (ATCC
BAA-427) | Old | 299 | 298 | 99 |
| Pseudomonas
aeruginosa (ATCC
BAA-427) | Middle | 292 | 288 | 102 |
| Pseudomonas
aeruginosa (ATCC
BAA-427) | New | 300 | 298 | 103 |
| Streptococcus
pneumoniae
(ATCC 6305) [10-4] | Old | 234 | 137 | 59 |
| Streptococcus
pneumoniae
(ATCC 6305) [10-4] | Middle | 227 | 147 | 67 |
| Streptococcus
pneumoniae
(ATCC 6305) [10-4] | New | 209 | 148 | 53 |
| Haemophilus
influenzae (ATCC
10211) | Old | 224 | 170 | 64 |
| Haemophilus
influenzae (ATCC
10211) | Middle | 216 | 172 | 71 |
| Haemophilus
influenzae (ATCC
10211) | New | 215 | 157 | 51 |
| Bacteroides fragilis
(ATCC 25285) | Old | 298 | 209 | 95 |
| Bacteroides fragilis
(ATCC 25285) | Middle | 240 | 179 | 73 |
| Bacteroides fragilis
(ATCC 25285) | New | 270 | 188 | 83 |
| Fusobacterium
nucleatum (ATCC
25586) | Old | 230 | 152 | 31 |
| Fusobacterium
nucleatum (ATCC
25586) | Middle | 222 | 145 | 35 |
| Fusobacterium
nucleatum (ATCC
25586) | New | 202 | 116 | 22 |
| Neisseria
gonorrhoeae (ATCC
43069) | Old | 250 | 131 | |
| Neisseria
gonorrhoeae (ATCC
43069) | Middle | 270 | 138 | |
| Neisseria
gonorrhoeae (ATCC
43069) | New | 268 | 135 | |
| Staphylococcus
aureus (MRSA)
(ATCC 43300) | Old | 252 | 141 | 70 |
| Staphylococcus
aureus (MRSA)
(ATCC 43300) | Middle | 246 | 134 | 58 |
| Staphylococcus
aureus (MRSA)
(ATCC 43300) | New | 247 | 121 | 56 |
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | Old | 284 | 115 | 53 |
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | Middle | 289 | 122 | 54 |
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | New | 290 | 117 | 47 |
11
Image /page/11/Picture/1 description: The image shows a logo for ARX Sciences. The logo features a stylized letter "A" in blue, with two red shapes inside the "A". Below the logo, the text "ARX SCIENCES" is written in a simple, sans-serif font. The logo appears to be for a company in the science or technology field.
- Neisseria gonorrhoeae recovery tested only at 24 hrs.
Swab Elution Method:
12
Image /page/12/Picture/1 description: The image shows the logo for ARX Sciences. The logo is a stylized letter A in blue, with a white space in the middle that resembles a double helix. There are two red shapes on either side of the A. Below the logo, the words "ARX SCIENCES" are written in blue.
For the Swab-Elution method, bacterial suspensions were prepared in NCM similar to the roll-plate method (as indicated in Table 3). The performance characteristics of ARX Liquid Amies Collection & Transport System were determined using the procedures outlined in CLSI M40-A2 using three sterile flocked swab types (i.e., NPS, nasopharyngeal swab, with or without tapered tip design; OPS, oropharyngeal swab) designed for throat, urogenital and nasal specimen collection. This study was conducted at two different temperatures to reflect refrigerated (2–8°C) and room temperature (25–30°C) conditions in NCM and used three (3) independent lots of ARX Liquid Amies representing old (Lot #A030921, post-production age at study: 23-24 months), middle-aged (Lot #AR1002, age: 6-7 months), and newly manufactured (Lot #A1229222, age: 1-2 months) lots. The swabs from each transport system were inoculated in triplicate with a specified volume of select bacterial suspensions prepared in NCM. These swabs were then placed in their respective transport vial and held for 0, 24, and 48 hrs. (except Neisseria gonorrhoeae held only for 24 hrs.); at the designated time intervals the swabs were removed and processed for recovery of bacterial CFU/mL counts (refer to Table 7 and Table 8).
Additional swab elution testing was performed using bacterial suspensions prepared and serially diluted in sterile saline to the desired concentration (as indicated in Table 2). The performance characteristics of ARX Liquid Amies Collection & Transport System in saline were determined as above using the two NPS types. This study was conducted at two different temperatures to reflect refrigerated (2-8°C) and room temperature (20–25°C) conditions in saline, along with the additional bacterial strains (as indicated in Table 2), and used three (3) independent lots of ARX Liquid Amies representing old (Lot #A030921; post-production age at study: 17 months), middle-aged (Lot #AR1001/2/3, age:6-7 months), and newly manufactured (Lot #A061422, age: 2 months) lots. The swabs from each transport system were inoculated in triplicate with a specified volume of select bacterial suspensions prepared in sterile saline, placed in their respective transport vials, and held for 0, 24, and 48 hrs. (except Neisseria gonorrhoeae held only for 24 hrs.); at the designated time intervals the swabs were removed and processed for recovery of bacterial CFU/mL counts (refer to Table 9 and Table 10).
| Organism
(ATCC Part #) | Lot
Age | Average
CFU/mL
Recovery:
Time 0 hr. | Average
CFU/mL
Recovery:
Time 24 hrs. | Average
CFU/mL
Recovery:
Time 48 hrs. | Change
in Log10
(0-48
hrs.)* |
|--------------------------------------------------|------------|----------------------------------------------|------------------------------------------------|------------------------------------------------|---------------------------------------|
| Haemophilus
influenzae (ATCC
10211) | Old | 2.84E+07 | 1.03E+07 | 3.58E+06 | -0.90 |
| Haemophilus
influenzae (ATCC
10211) | Middle | 3.00E+07 | 1.08E+07 | 4.05E+06 | -0.87 |
| Haemophilus
influenzae (ATCC
10211) | New | 3.05E+07 | 1.12E+07 | 4.08E+06 | -0.87 |
| Streptococcus
pneumoniae (ATCC
6305) | Old | 1.62E+07 | 5.43E+06 | 2.18E+06 | -0.87 |
| Streptococcus
pneumoniae (ATCC
6305) | Middle | 1.85E+07 | 5.58E+06 | 2.23E+06 | -0.92 |
| Streptococcus
pneumoniae (ATCC
6305) | New | 1.94E+07 | 5.72E+06 | 2.20E+06 | -0.94 |
| Staphylococcus)
aureus (MRSA)
(ATCC 43300) | Old | 2.40E+07 | 5.40E+06 | 3.03E+06 | -0.90 |
| Staphylococcus)
aureus (MRSA)
(ATCC 43300) | Middle | 2.59E+07 | 6.30E+06 | 3.60E+06 | -0.86 |
| Staphylococcus)
aureus (MRSA)
(ATCC 43300) | New | 2.65E+07 | 7.23E+06 | 3.23E+06 | -0.91 |
| Pseudomonas
aeruginosa (ATCC
BAA-427) | Old | 1.10E+07 | 8.80E+06 | 4.00E+06 | -0.44 |
| Pseudomonas
aeruginosa (ATCC
BAA-427) | Middle | 1.21E+07 | 9.90E+06 | 4.00E+06 | -0.48 |
| Pseudomonas
aeruginosa (ATCC
BAA-427) | New | 1.29E+07 | 1.02E+07 | 4.67E+06 | -0.44 |
| Neisseria
gonorrhoeae (ATCC
43069) | Old | 2.97E+07 | 2.06E+07 | | -0.85 |
| Neisseria
gonorrhoeae (ATCC
43069) | Middle | 3.12E+07 | 2.19E+07 | | -0.77 |
| Neisseria
gonorrhoeae (ATCC
43069) | New | 3.21E+07 | 2.22E+07 | | -0.74 |
| | Old | 1.56E+07 | 8.29E+06 | 4.48E+06 | -0.54 |
Table 7: Swab Elution Method of Bacterial Recovery following Storage at Refrigerated (2-8°C) Conditions using NCM.
13
Image /page/13/Picture/1 description: The image shows the logo for ARX Sciences. The logo is a stylized letter "A" in blue, with a white line running down the middle. There are two red rectangles on either side of the white line. Below the logo, the words "ARX SCIENCES" are written in a sans-serif font.
| Organism
(ATCC Part #) | Lot
Age | Average
CFU/mL
Recovery:
Time 0 hr. | Average
CFU/mL
Recovery:
Time 24 hrs. | Average
CFU/mL
Recovery:
Time 48 hrs. | Change
in Log10
(0-48
hrs.)* |
|-------------------------------------------------------------|------------|----------------------------------------------|------------------------------------------------|------------------------------------------------|---------------------------------------|
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | Middle | 1.63E+07 | 9.24E+06 | 5.19E+06 | -0.50 |
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | New | 1.66E+07 | 9.73E+06 | 5.30E+06 | -0.49 |
| Bacteroides fragilis
(ATCC 25285) | Old | 2.40E+06 | 1.89E+06 | 8.00E+05 | -0.48 |
| Bacteroides fragilis
(ATCC 25285) | Middle | 2.49E+06 | 1.88E+06 | 8.03E+05 | -0.49 |
| Bacteroides fragilis
(ATCC 25285) | New | 2.47E+06 | 1.88E+06 | 8.18E+05 | -0.48 |
| Fusobacterium
nucleatum (ATCC
25586) | Old | 2.26E+06 | 1.37E+06 | 3.37E+05 | -0.83 |
| Fusobacterium
nucleatum (ATCC
25586) | Middle | 2.32E+06 | 1.40E+06 | 3.38E+05 | -0.84 |
| Fusobacterium
nucleatum (ATCC
25586) | New | 2.28E+06 | 1.40E+06 | 3.42E+05 | -0.82 |
Neisseria gonorrhoeae Change in Log10 is (0-24 hrs.)
| Table 8: Swab Elution Method of Bacterial Recovery following Storage at Room Temperature (25- | ||||
|---|---|---|---|---|
| 30°C) Conditions using NCM. |
| Organism
(ATCC Part #) | Lot
Age | Average
CFU/ml
Recovery:
Time 0 hr. | Average
CFU/ml
Recovery:
Time 24 hrs. | Average
CFU/ml
Recovery:
Time 48 hrs. | Change
in Log10
(0-48
hrs.)* |
|-------------------------------------------------------------|------------------------------------------|----------------------------------------------|------------------------------------------------|------------------------------------------------|---------------------------------------|
| Haemophilus | Old | 2.22E+07 | 1.67E+07 | 6.32E+06 | -0.54 |
| influenzae (ATCC | Middle | 2.22E+07 | 1.62E+07 | 5.98E+06 | -0.57 |
| 10211) | New | 2.42E+07 | 1.66E+07 | 5.82E+06 | -0.62 |
| Streptococcus | Old | 2.25E+07 | 1.35E+07 | 5.37E+06 | -0.62 |
| pneumoniae (ATCC | Middle | 2.33E+07 | 1.43E+07 | 6.48E+06 | -0.55 |
| 6305) | New | 2.37E+07 | 1.41E+07 | 6.08E+06 | -0.59 |
| Staphylococcus | Old | 2.11E+07 | 1.86E+07 | 8.03E+06 | -0.42 |
| aureus (MRSA) | Middle | 2.18E+07 | 1.91E+07 | 7.53E+06 | -0.46 |
| (ATCC 43300) | New | 2.10E+07 | 1.85E+07 | 8.07E+06 | -0.42 |
| Pseudomonas | Old | 1.52E+07 | 8.40E+06 | 4.20E+06 | -0.56 |
| aeruginosa (ATCC
BAA-427) | Middle | 1.64E+07 | 9.33E+06 | 5.20E+06 | -0.50 |
| | New | 1.66E+07 | 9.70E+06 | 5.37E+06 | -0.49 |
| | Neisseria
gonorrhoeae (ATCC
43069) | Old | 2.67E+07 | 1.91E+07 | |
| Middle | | 2.73E+07 | 1.04E+07 | | -0.42 |
| New | | 2.78E+07 | 1.01E+07 | | -0.44 |
| Streptococcus | Old | 1.60E+07 | 6.90E+06 | 4.03E+06 | -0.60 |
| agalactiae (Group B
Strep) (ATCC 13813) | Middle | 1.67E+07 | 7.45E+06 | 4.23E+06 | -0.60 |
| | New | 1.71E+07 | 8.44E+06 | 4.40E+06 | -0.59 |
| | Bacteroides fragilis
(ATCC 25285) | Old | 2.83E+06 | 1.87E+06 | 7.58E+05 |
| Middle | | 2.86E+06 | 1.91E+06 | 8.18E+05 | -0.54 |
| New | | 2.93E+06 | 1.94E+06 | 8.25E+05 | -0.55 |
| Fusobacterium | Old | 2.11E+06 | 1.54E+06 | 3.50E+05 | -0.78 |
| nucleatum (ATCC | Middle | 2.16E+06 | 1.54E+06 | 3.45E+05 | -0.80 |
| 25586) | New | 2.21E+06 | 1.54E+06 | 3.60E+05 | -0.79 |
| Organism
(ATCC Part #) | Lot
Age | Average
CFU/ml
Recovery:
Time 0 hr. | Average
CFU/ml
Recovery:
Time 24 hrs. | Average
CFU/ml
Recovery:
Time 48 hrs. | Change
in Log10
(0-48
hrs.)* |
| Streptococcus
pyogenes (ATCC
19615) | Old | 5.90E+06 | 2.77E+06 | 6.33E+05 | -0.97 |
| Streptococcus
pyogenes (ATCC
19615) | Middle | 6.30E+06 | 2.97E+06 | 8.00E+05 | -0.90 |
| Streptococcus
pyogenes (ATCC
19615) | New | 6.13E+06 | 2.93E+06 | 7.33E+05 | -0.92 |
| Peptostreptococcus
anaerobius (ATCC
27337) | Old | 1.63E+06 | 8.73E+05 | 1.53E+05 | -1.03 |
| Peptostreptococcus
anaerobius (ATCC
27337) | Middle | 1.62E+06 | 8.20E+05 | 1.47E+05 | -1.04 |
| Peptostreptococcus
anaerobius (ATCC
27337) | New | 1.57E+06 | 7.07E+05 | 1.33E+05 | -1.07 |
| Propionibacterium
acnes (ATCC 6919) | Old | 3.27E+08 | 1.27E+08 | 4.37E+07 | -0.87 |
| Propionibacterium
acnes (ATCC 6919) | Middle | 3.18E+08 | 1.17E+08 | 3.80E+07 | -0.92 |
| Propionibacterium
acnes (ATCC 6919) | New | 3.25E+08 | 1.28E+08 | 3.07E+07 | -1.02 |
| Prevotella
melaninogenica
(ATCC 25845) | Old | 2.95E+08 | 7.57E+07 | 2.40E+07 | -1.09 |
| Prevotella
melaninogenica
(ATCC 25845) | Middle | 2.89E+08 | 7.53E+07 | 3.17E+07 | -0.96 |
| Prevotella
melaninogenica
(ATCC 25845) | New | 2.92E+08 | 9.03E+07 | 3.57E+07 | -0.91 |
| Enterococcus
faecalis (ATCC
51299) | Old | 1.42E+07 | 8.00E+06 | 2.60E+06 | -0.74 |
| Enterococcus
faecalis (ATCC
51299) | Middle | 1.45E+07 | 7.47E+06 | 2.83E+06 | -0.71 |
| Enterococcus
faecalis (ATCC
51299) | New | 1.48E+07 | 7.43E+06 | 2.73E+06 | -0.73 |
| Clostridium
perfringens (Strain S-
107) (ATCC 13124) | Old | 2.98E+07 | 1.19E+07 | 3.30E+06 | -0.96 |
| Clostridium
perfringens (Strain S-
107) (ATCC 13124) | Middle | 2.91E+06 | 1.24E+07 | 4.20E+06 | -0.84 |
| Clostridium
perfringens (Strain S-
107) (ATCC 13124) | New | 3.00E+07 | 1.29E+07 | 4.13E+06 | -0.86 |
| Clostridium
sporogenes (ATCC
3584) | Old | 2.83E+07 | 1.75E+07 | 8.43E+06 | -0.53 |
| Clostridium
sporogenes (ATCC
3584) | Middle | 2.74E+07 | 1.74E+07 | 9.07E+06 | -0.48 |
| Clostridium
sporogenes (ATCC
3584) | New | 2.89E+07 | 1.80E+07 | 6.20E+06 | -0.67 |
| Finegoldia magna
(Strain WAL2508)
(ATCC 29328) | Old | 2.02E+07 | 8.53E+06 | 3.13E+06 | -0.81 |
| Finegoldia magna
(Strain WAL2508)
(ATCC 29328) | Middle | 2.10E+07 | 6.90E+06 | 3.03E+06 | -0.84 |
| Finegoldia magna
(Strain WAL2508)
(ATCC 29328) | New | 2.19E+07 | 7.57E+06 | 2.60E+06 | -0.93 |
| Fusobacterium
necrophorum (ATCC
25286) | Old | 2.92E+07 | 1.51E+07 | 5.83E+06 | -0.70 |
| Fusobacterium
necrophorum (ATCC
25286) | Middle | 3.02E+07 | 1.52E+07 | 5.57E+06 | -0.73 |
| Fusobacterium
necrophorum (ATCC
25286) | New | 2.98E+07 | 1.56E+07 | 3.40E+06 | -0.94 |
| Pseudomonas
aeruginosa (ATCC
BAA-427) | Old | 1.02E+06 | 9.43E+05 | 2.70E+05 | -0.58 |
| Pseudomonas
aeruginosa (ATCC
BAA-427) | Middle | 1.01E+06 | 9.43E+05 | 2.87E+05 | -0.55 |
| Pseudomonas
aeruginosa (ATCC
BAA-427) | New | 1.03E+06 | 9.47E+05 | 2.93E+05 | -0.55 |
| Streptococcus
pneumoniae (ATCC
6305) | Old | 1.83E+06 | 4.70E+05 | 1.60E+05 | -1.06 |
| Streptococcus
pneumoniae (ATCC
6305) | Middle | 1.75E+06 | 4.83E+05 | 1.40E+05 | -1.10 |
| Streptococcus
pneumoniae (ATCC
6305) | New | 1.86E+06 | 4.83E+05 | 1.63E+05 | -1.06 |
| Haemophilus
influenzae (ATCC
10211) | Old | 3.07E+06 | 8.17E+05 | 3.37E+05 | -0.96 |
| Haemophilus
influenzae (ATCC
10211) | Middle | 3.13E+06 | 9.40E+05 | 3.03E+05 | -1.01 |
| Haemophilus
influenzae (ATCC
10211) | New | 3.11E+06 | 9.53E+05 | 3.13E+05 | -1.00 |
| Bacteroides fragilis
(ATCC 25285) | Old | 9.50E+04 | 3.60E+04 | 1.50E+04 | -0.80 |
| Bacteroides fragilis
(ATCC 25285) | Middle | 8.70E+04 | 3.27E+04 | 1.63E+04 | -0.73 |
| Bacteroides fragilis
(ATCC 25285) | New | 8.63E+04 | 4.10E+04 | 1.57E+04 | -0.74 |
| Fusobacterium
nucleatum (ATCC
25586) | Old | 2.33E+05 | 6.43E+04 | 1.70E+04 | -1.14 |
| Fusobacterium
nucleatum (ATCC
25586) | Middle | 2.25E+05 | 6.03E+04 | 1.70E+04 | -1.12 |
| Fusobacterium
nucleatum (ATCC
25586) | New | 2.22E+05 | 6.67E+04 | 1.97E+04 | -1.05 |
| Fusobacterium
nucleatum (ATCC
25586) | Old | 3.23E+06 | 2.13E+06 | | -0.18 |
| Fusobacterium
nucleatum (ATCC
25586) | Middle | 3.21E+06 | 2.05E+06 | | -0.19 |
| Organism
(ATCC Part #) | Lot
Age | Average
CFU/ml
Recovery:
Time 0 hr. | Average
CFU/ml
Recovery:
Time 24 hrs. | Average
CFU/ml
Recovery:
Time 48 hrs. | Change
in Log10
(0-48
hrs.)* |
| Neisseria
gonorrhoeae (ATCC
43069) | New | 3.24E+06 | 1.99E+06 | | -0.21 |
| Staphylococcus
aureus (MRSA)
(ATCC 43300) | Old | 8.00E+05 | 2.60E+05 | 1.00E+05 | -1.19 |
| Staphylococcus
aureus (MRSA)
(ATCC 43300) | Middle | 7.47E+05 | 2.83E+05 | 1.03E+05 | -1.08 |
| Staphylococcus
aureus (MRSA)
(ATCC 43300) | New | 7.43E+05 | 2.73E+05 | 9.00E+04 | -1.09 |
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | Old | 1.64E+06 | 8.37E+05 | 4.77E+05 | -0.54 |
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | Middle | 1.56E+06 | 8.37E+05 | 4.20E+05 | -0.57 |
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | New | 1.65E+06 | 8.17E+05 | 5.13E+05 | -0.51 |
- Neisseria gonorrhoeae Change in Log10 is (0–24 hrs.)
Table 9: Swab Elution Method of Bacterial Recovery following Storage at Refrigerated (2–8°C) Conditions in Saline.
14
Image /page/14/Picture/1 description: The image features a logo for "ARX SCIENCES". The logo consists of a stylized letter "A" in a dark blue color. Inside the "A" are two red rectangles, one on each side. Below the logo, the words "ARX SCIENCES" are written in a simple, sans-serif font, also in dark blue.
15
Image /page/15/Picture/1 description: The image shows the logo for ARX Sciences. The logo is a stylized letter "A" in blue, with two red shapes inside the "A". The text "ARX SCIENCES" is written in blue below the logo. The logo is simple and modern, and the colors are eye-catching.
Neisseria gonorrhoeae Change in Log10 is (0-24 hrs.)
Table 10: Swab Elution Method of Bacterial Recovery following Storage at Room Temperature (20 25°C) Conditions using Saline.
| Organism
(ATCC Part #) | Lot
Age | Average
CFU/ml
Recovery:
Time 0 hr. | Average
CFU/ml
Recovery:
Time 24 hrs. | Average
CFU/ml
Recovery:
Time 48 hrs. | Change
in Log10
(0-48 hrs.)* |
|------------------------------------------------------------|------------|----------------------------------------------|------------------------------------------------|------------------------------------------------|------------------------------------|
| Streptococcus
pyogenes (ATCC
19615) | Old | 2.54E+07 | 2.27E+07 | 1.20E+07 | -0.32 |
| Streptococcus
pyogenes (ATCC
19615) | Middle | 2.30E+07 | 1.93E+07 | 9.70E+06 | -0.38 |
| Streptococcus
pyogenes (ATCC
19615) | New | 1.99E+07 | 1.77E+07 | 7.73E+06 | -0.41 |
| Peptostreptococcus
anaerobius (ATCC
27337) | Old | 2.23E+06 | 1.50E+06 | 3.20E+05 | -0.84 |
| Peptostreptococcus
anaerobius (ATCC
27337) | Middle | 2.48E+06 | 1.76E+06 | 4.03E+05 | -0.79 |
| Peptostreptococcus
anaerobius (ATCC
27337) | New | 2.20E+06 | 1.40E+06 | 2.93E+05 | -0.88 |
| Propionibacterium
acnes (ATCC 6919) | Old | 2.53E+08 | 1.63E+08 | 4.37E+07 | -0.76 |
| Propionibacterium
acnes (ATCC 6919) | Middle | 2.58E+08 | 1.57E+08 | 3.80E+07 | -0.83 |
| Propionibacterium
acnes (ATCC 6919) | New | 2.25E+08 | 1.28E+08 | 3.07E+07 | -0.86 |
| Prevotella
melaninogenica
(ATCC 25845) | Old | 2.61E+08 | 1.22E+08 | 3.07E+07 | -0.93 |
| Prevotella
melaninogenica
(ATCC 25845) | Middle | 2.52E+08 | 1.19E+08 | 3.90E+07 | -0.81 |
| Prevotella
melaninogenica
(ATCC 25845) | New | 2.68E+08 | 1.27E+08 | 4.40E+07 | -0.79 |
| Enterococcus
faecalis (ATCC
51299) | Old | 1.71E+07 | 5.63E+06 | 3.30E+06 | -0.71 |
| Enterococcus
faecalis (ATCC
51299) | Middle | 1.58E+07 | 5.97E+06 | 3.67E+06 | -0.64 |
| Enterococcus
faecalis (ATCC
51299) | New | 1.68E+07 | 5.47E+06 | 3.00E+06 | -0.75 |
| Clostridium
perfringens (Strain S-
107) (ATCC 13124) | Old | 2.75E+06 | 1.43E+07 | 4.83E+06 | -0.76 |
| Clostridium
perfringens (Strain S-
107) (ATCC 13124) | Middle | 2.69E+07 | 1.43E+07 | 4.50E+06 | -0.78 |
| Clostridium
perfringens (Strain S-
107) (ATCC 13124) | New | 2.78E+07 | 1.46E+07 | 4.20E+06 | -0.82 |
| Clostridium
sporogenes (ATCC
3584) | Old | 2.62E+07 | 1.42E+07 | 5.87E+06 | -0.65 |
| Clostridium
sporogenes (ATCC
3584) | Middle | 2.50E+07 | 1.34E+07 | 5.07E+06 | -0.69 |
| Clostridium
sporogenes (ATCC
3584) | New | 2.58E+07 | 1.51E+07 | 5.17E+06 | -0.70 |
| Finegoldia magna
(Strain WAL2508)
(ATCC 29328) | Old | 1.94E+07 | 7.17E+06 | 6.37E+06 | -0.48 |
| Finegoldia magna
(Strain WAL2508)
(ATCC 29328) | Middle | 1.88E+07 | 6.93E+06 | 6.53E+06 | -0.46 |
| Finegoldia magna
(Strain WAL2508)
(ATCC 29328) | New | 1.97E+07 | 6.33E+06 | 6.07E+06 | -0.51 |
| Fusobacterium
necrophorum (ATCC
25286) | Old | 2.92E+07 | 1.48E+07 | 5.57E+06 | -0.72 |
| Fusobacterium
necrophorum (ATCC
25286) | Middle | 2.78E+07 | 1.44E+07 | 5.23E+06 | -0.72 |
| Fusobacterium
necrophorum (ATCC
25286) | New | 2.72E+07 | 1.59E+07 | 4.60E+06 | -0.77 |
| | Old | 1.26E+06 | 1.68E+06 | 1.22E+06 | -0.53 |
16
Image /page/16/Picture/1 description: The image shows the logo for ARX Sciences. The logo is a stylized letter "A" in blue, with two red capsules inside the letter. Below the letter "A" is the text "ARX SCIENCES" in a simple sans-serif font. The logo is clean and modern, and the colors are bold and eye-catching.
| Organism
(ATCC Part #) | Lot
Age | Average
CFU/ml
Recovery:
Time 0 hr. | Average
CFU/ml
Recovery:
Time 24 hrs. | Average
CFU/ml
Recovery:
Time 48 hrs. | Change
in Log10
(0-48
hrs.)* |
|-------------------------------------------------------------|------------|----------------------------------------------|------------------------------------------------|------------------------------------------------|---------------------------------------|
| Pseudomonas
aeruginosa (ATCC
BAA-427) | Middle | 1.35E+06 | 1.68E+06 | 1.19E+06 | -0.51 |
| Pseudomonas
aeruginosa (ATCC
BAA-427) | New | 1.16E+06 | 1.55E+06 | 1.10E+06 | -0.53 |
| Streptococcus
pneumoniae (ATCC
6305) | Old | 2.34E+06 | 1.37E+06 | 5.60E+05 | -0.62 |
| Streptococcus
pneumoniae (ATCC
6305) | Middle | 2.27E+06 | 1.47E+06 | 6.67E+05 | -0.53 |
| Streptococcus
pneumoniae (ATCC
6305) | New | 2.09E+06 | 1.47E+06 | 5.27E+05 | -0.60 |
| Haemophilus
influenzae (ATCC
10211) | Old | 2.24E+06 | 1.70E+06 | 6.43E+05 | -0.54 |
| Haemophilus
influenzae (ATCC
10211) | Middle | 2.16E+06 | 1.72E+06 | 7.10E+05 | -0.48 |
| Haemophilus
influenzae (ATCC
10211) | New | 2.15E+06 | 1.57E+06 | 5.13E+05 | -0.62 |
| Bacteroides fragilis
(ATCC 25285) | Old | 2.98E+05 | 2.09E+05 | 7.50E+04 | -0.60 |
| Bacteroides fragilis
(ATCC 25285) | Middle | 2.40E+05 | 1.79E+05 | 7.30E+04 | -0.52 |
| Bacteroides fragilis
(ATCC 25285) | New | 2.70E+05 | 1.88E+05 | 8.27E+04 | -0.51 |
| Fusobacterium
nucleatum (ATCC
25586) | Old | 2.30E+05 | 1.52E+05 | 3.13E+04 | -0.87 |
| Fusobacterium
nucleatum (ATCC
25586) | Middle | 2.22E+05 | 1.45E+05 | 3.47E+04 | -0.81 |
| Fusobacterium
nucleatum (ATCC
25586) | New | 2.02E+05 | 1.16E+05 | 2.40E+04 | -0.93 |
| Neisseria
gonorrhoeae (ATCC
43069) | Old | 2.60E+06 | 9.40E+05 | | -0.44 |
| Neisseria
gonorrhoeae (ATCC
43069) | Middle | 2.80E+06 | 9.43E+05 | | -0.47 |
| Neisseria
gonorrhoeae (ATCC
43069) | New | 2.92E+06 | 9.67E+05 | | -0.48 |
| Staphylococcus
aureus (MRSA)
(ATCC 43300) | Old | 2.05E+06 | 1.92E+06 | 8.43E+05 | -0.39 |
| Staphylococcus
aureus (MRSA)
(ATCC 43300) | Middle | 2.20E+06 | 1.99E+06 | 7.63E+05 | -0.46 |
| Staphylococcus
aureus (MRSA)
(ATCC 43300) | New | 2.20E+06 | 1.95E+06 | 7.83E+05 | -0.45 |
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | Old | 1.72E+06 | 7.80E+05 | 4.47E+05 | -0.58 |
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | Middle | 1.37E+06 | 5.10E+05 | 3.77E+05 | -0.56 |
| Streptococcus
agalactiae (Group B
Strep) (ATCC 13813) | New | 1.74E+06 | 7.90E+05 | 4.43E+05 | -0.59 |
- Neisseria gonorrhoeae Change in Log10 is (0-24 hrs.)
Additional studies were conducted with four (4) manufactured lots of ARX Liquid Amies Collection & Transport System for the evaluation of shelf-life stability at room temperature (20–25°C) in real time in support of claims of media stability prior to sample collection, as shown in Table 11. The outcomes were acceptable and supported a stability claim of 18 months on the shelf for ARX Liquid Amies Collection & Transport System.
| Table 11: Summary of Shelf-life Stability studies with ARX Liquid Amies Collection & Transport | ||||
|---|---|---|---|---|
| Svstem | ||||
| Shelf-life Stability
tests in real time | Test
Interval | Test Outcome |
|--------------------------------------------|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (a) pH monitoring | Monthly | Random tubes from independent lots stored at room temperatures
(20–25°C) maintained their pH within the specified range (7.30 ±
0.2) with testing time ranging from time zero through 18 months. |
| (b) Visual estimation
of turbidity | Monthly | Random tubes from independent lots stored at room temperatures
(20–25°C) passed visual inspection with testing time ranging from
time zero through 18 months. |
17
Image /page/17/Picture/1 description: The image shows the logo for ARX Sciences. The logo is a stylized letter "A" in blue, with two red bars inside the "A" that are angled towards the center. The text "ARX SCIENCES" is written in blue below the logo. The logo is simple and modern, and the colors are eye-catching.
| (c) Viscosity
measurement | 4-month | Random tubes from independent lots stored at room temperatures
(20–25°C) maintained viscosity within a range of $1.075 \pm 0.015$
milliPascal.Second with testing time ranging from time zero
through 18 months. |
| ------------------------------ | --------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Conclusions from non-clinical Performance Studies:
Using both the Roll-Plate and Swab Elution Methods, the ARX Liquid Amies Collection & Transport System showed recovery of bacteria within the acceptance criteria comparable to the predicate device for all holding temperatures tested. This demonstrates the acceptability claim of up to 48 hours for all organisms (except 24 hours for Neisseria gonorrhoeae) in clinical samples during storage and/or transport in this transport system. Additional studies conducted with the ARX Liquid Amies Collection & Transport System support the shelf-life stability claim of 18 months.