(575 days)
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.
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.
The provided text describes the performance characteristics of the ARX Liquid Amies Collection & Transport System for bacterial recovery. This information is relevant to the acceptance criteria and the study proving the device meets these criteria.
Here's an analysis of the provided information to address your request:
Device: ARX Liquid Amies Collection & Transport System
Purpose of Study: To demonstrate the ability of the device to maintain the viability of aerobic, anaerobic, and fastidious bacteria during specimen transport, and to establish shelf-life stability.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for bacterial recovery are stated as:
- Roll-Plate studies: Minimum acceptable viability of at least 2% CFU relative to time 0.
- Swab Elution studies: Maximum 3 log10 decline in CFU acceptable relative to time 0.
For shelf-life stability:
- pH within specified range (7.30 ± 0.2).
- Visual inspection (no turbidity).
- Viscosity within specified range (1.075 ± 0.015 milliPascal.Second).
Table: Acceptance Criteria and Reported Device Performance (Summary)
| Performance Characteristic | Acceptance Criteria | Reported Device Performance (Overall Conclusion) |
|---|---|---|
| Bacterial Recovery | ||
| Roll-Plate Method | Minimum 2% CFU viability relative to Time 0 for all organisms (N. gonorrhoeae: 24 hrs; others: 48 hrs). | Met: "the performance of all bacterial recovery, when used with or without NCM, was found to be acceptable." (Tables 3-6 provide detailed CFUs validating this). |
| Swab Elution Method | Maximum 3 Log10 decline in CFU relative to Time 0 for all organisms (N. gonorrhoeae: 24 hrs; others: 48 hrs). | Met: "the performance of all bacterial recovery, when used with or without NCM, was found to be acceptable." (Tables 7-10 provide detailed Log10 changes validating this, with all values less than 3 log10 decline). |
| Shelf-Life Stability | ||
| pH monitoring | pH within 7.30 ± 0.2 | Met: Maintained pH within specified range for 18 months. |
| Visual estimation of turbidity | Pass visual inspection | Met: Passed visual inspection for 18 months. |
| Viscosity measurement | Viscosity within 1.075 ± 0.015 milliPascal.Second | Met: Maintained viscosity within specified range for 18 months. |
Conclusion from non-clinical Performance Studies: "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."
2. Sample Size Used for the Test Set and Data Provenance
The "test set" in this context refers to the bacterial strains and conditions used for the performance studies, not a patient-derived dataset.
-
Sample Size (Test Set):
- Bacterial Strains: A total of 17 bacterial strains were used:
- 3 aerobic bacteria
- 6 facultative anaerobic bacteria (including 1 fastidious organism, Neisseria gonorrhoeae)
- 8 obligate anaerobic bacteria (listed in Table 2)
- Device Samples: For each study (Roll-Plate and Swab Elution, with NCM and Saline at different temperatures):
- 3 independent lots of ARX Liquid Amies (Old, Middle-aged, New) were tested.
- For each combination of organism, lot, and temperature/matrix, the swabs were inoculated in triplicate.
- Measurements were taken at 0, 24, and 48 hours (except N. gonorrhoeae only at 24 hours).
- Shelf-life Stability: 4 manufactured lots were evaluated.
- Bacterial Strains: A total of 17 bacterial strains were used:
-
Data Provenance: The data appears to be from controlled laboratory studies (prospective experimental data) conducted to validate the device's performance. The document does not specify a country of origin for the data, but given it's an FDA submission, it's typically either conducted in the US or in adherence to international standards acceptable to the FDA. The matrices used were "Negative Clinical Matrix (NCM) or sterile saline," simulating clinical conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (microbiological specimen collection and transport system) relies on established microbiological laboratory standards and quantitative measurements (CFU counts) rather than subjective expert interpretation of medical images or pathologies. Therefore, there is no mention of "experts" in the traditional sense (e.g., radiologists) establishing ground truth. The "ground truth" here is determined by the live cultures and their measured viability, following universally accepted laboratory protocols.
- Number of Experts: Not applicable in the context of expert consensus for ground truth on images or clinical outcomes.
- Qualifications of Experts: Not applicable. The "ground truth" (bacterial viability) is established by direct laboratory measurements following CLSI M40-A2 standards.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or algorithms provide interpretations, and a consensus or higher-level review is needed to establish a definitive ground truth.
For this device, the "ground truth" is based on direct quantitative laboratory measurements (colony forming unit counts) of bacterial viability. These are objective measures, not subjective interpretations. Therefore:
- Adjudication Method: Not applicable. Ground truth is derived from direct quantitative microbiological assays.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
MRMC studies are typically performed for diagnostic devices (e.g., AI-powered imaging systems) where human interpretation plays a role, and the goal is to assess how a new technology impacts diagnostic performance.
This device is a specimen collection and transport system, not a diagnostic imaging or AI-driven interpretive tool. The study focuses on the physical and biological performance of the transport medium and swabs in maintaining bacterial viability.
- MRMC Study: No, an MRMC study was not done as it is not relevant for this type of device.
- Effect Size of Human Readers: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The concept of "standalone performance" typically refers to the performance of an AI algorithm independent of human intervention. This device is not an AI algorithm. Its performance is inherent to its physical and biological properties.
- Standalone Performance: Not applicable. This is not an AI device. The studies conducted evaluate the intrinsic performance of the device itself (transport medium and swabs) in preserving bacterial samples.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the performance studies was bacterial viability/colony counts (CFU) established through controlled laboratory experiments. This is a direct, quantitative measure of the device's ability to preserve the bacteria. The studies followed FDA-recognized sections of Clinical Laboratory Standards Institute (CLSI) M40-A2:2014 Quality Control of Microbiological Transport Systems.
8. The Sample Size for the Training Set
This device is not an AI/ML device, and therefore does not have a "training set" in the computational sense. The studies described are validation and performance testing, not model training.
- Sample Size for Training Set: Not applicable, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device in the context of AI/ML, this question is not applicable. The device's performance is based on its material properties and chemical composition, validated through standard microbiology testing.
- How Ground Truth for Training Set Was Established: Not applicable.
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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
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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
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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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Image /page/3/Picture/1 description: The image features the logo for ARX SCIENCES. The logo is a stylized letter "A" in blue, with a white shape in the center and two red shapes on either side. Below the logo, the text "ARX SCIENCES" is written in a simple, sans-serif font.
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 deviceClass I |
| Product Codes: | LIO: Device, Specimen CollectionJTW: System, Transport, AerobicJTX: Transport Systems, Anaerobic |
| Predicate Device: | K120846 Transport Culture Medium DevicePuritan 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 & PredicateDevice(s): | Device: K222613 | Predicate: K120846 |
|---|---|---|
| Device Trade Name | ARX Liquid Amies Collection & TransportSystem | Puritan Liquid AmiesCollection andTransport System |
| General DeviceCharacteristic Similarities | ||
| Intended Use/Indications ForUse | The ARX Liquid Amies Collection &Transport System (ARX) is intended for usein the collection of clinical specimens (i.e.,nasal secretion/wash; lachrymalsecretion/tears; auricular secretion/cerumen;urethral, rectal, or vaginal swab;wound/abscess material) potentiallycontaining aerobic, anaerobic, andfastidious bacteria and their transport at 2-8°C or 25-30°C from the patient to thelaboratory for bacteriological examinationand culture. In the laboratory, the collectedand transported clinical specimens of nasal,lachrymal, ceruminous, vaginal, urethral,rectal, and wound/abscess origin areprocessed using standard clinical laboratoryoperating procedures for bacterial culture. | Puritan Liquid AmiesCollection andTransport System isintended for use in thecollection andtransport of clinicalspecimens containingaerobic, anaerobicand fastidiousbacteria from thepatient to thelaboratory forbacteriologicalexamination andculture. |
| 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 collectionswabs 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 & PredicateDevice(s): | Device: K222613 | Predicate: K120846 |
|---|---|---|
| Transport Medium tube /volume | Plastic (polypropylene) / 1 mL | SAME |
| Swab shaft | Plastic, pre-scored | SAME |
| Amies Formulation | Sodium chlorideDisodium phosphateSodium thioglycolateMonopotassium phosphatePotassium chlorideCalcium chlorideMagnesium 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 DeviceCharacteristic Differences | ||
| Kit configuration | Medium tubes (50 count) in a kit box withblister peel pouches (50 count) with swabsinside | Single peel pouchcontaining sterileswab and Mediumtube |
| 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 (ATCCPart #) | Characteristic | 0.5 McFarlandsuspensiondiluted with | Matrix (Swab Types: NPS,nasopharyngeal, includingtapered tip type; OPS,oropharyngeal) | ||
|---|---|---|---|---|---|
| NCM | Saline | NCM | Saline | ||
| Haemophilusinfluenzae (ATCC10211) | Facultativeanaerobe | 10-4 | 10-4 | NasalIrrigation/Wash(NPS & OPS) | (NPS) |
| Streptococcuspneumoniae(ATCC 6305) | Facultativeanaerobe | 10-4 | 10-4 | NasalIrrigation/Wash(NPS & OPS) | (NPS) |
| Staphylococcusaureus (MRSA)(ATCC 43300) | Aerobe | 10-4 | 10-4 | Tears, PooledHuman Donors(NPS) | (NPS) |
| Pseudomonasaeruginosa (ATCCBAA-427) | Aerobe | 10-4 | 10-4 | Auricularmaterial/cerumen(NPS) | (NPS) |
| Streptococcusagalactiae (GroupB Strep) (ATCC13813) | Aerobe | 10-4 | 10-4 | Vaginal & RectalSwab (NPS & OPS) | (NPS) |
| Neisseriagonorrhoeae(ATCC 43069) | Fastidious,facultativeAnaerobe | 10-4 | 10-4 | Vaginal Swab (NPS& OPS); UrethralSwab (NPS) | (NPS) |
| Bacteroides fragilis(ATCC 25285) | Anaerobe | 10-3 | 10-3 | Wound/Abscess(NPS & OPS) | (NPS) |
| Fusobacteriumnucleatum (ATCC25586) | Anaerobe | 10-3 | 10-3 | Wound/Abscess(NPS & OPS) | (NPS) |
| Streptococcuspyogenes (ATCC19615) | Facultativeanaerobe | 10-4 | (NPS) | ||
| Propionibacteriumacnes (ATCC6919) | Facultativeanaerobe | 10-5 | (NPS) | ||
| Enterococcusfaecalis (ATCC51299) | Facultativeanaerobe | 10-4 | (NPS) | ||
| Peptostreptococcusanaerobius (ATCC27337) | Anaerobe | 10-3 | (NPS) | ||
| Prevotellamelaninogenica(ATCC 25845) | Anaerobe | 10-5 | (NPS) | ||
| Bacteria (ATCCPart #) | Characteristic | 0.5 McFarlandsuspensiondiluted with | Matrix (Swab Types: NPS,nasopharyngeal, includingtapered tip type; OPS,oropharyngeal) | ||
| NCM | Saline | NCM | Saline | ||
| Clostridiumperfringens (StrainS 107) (ATCC13124) | Anaerobe | 10-4 | (NPS) | ||
| Clostridiumsporogenes (ATCC3584) | Anaerobe | 10-4 | (NPS) | ||
| Finegoldia magna(Strain WAL2508)(ATCC 29328) | Anaerobe | 10-4 | (NPS) | ||
| Fusobacteriumnecrophorum(ATCC 25286) | Anaerobe | 10-4 | (NPS) |
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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.
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| Organism(ATCC Part #) | LotAge | AverageCFUsRecovered:Time 0 hr. | AverageCFUsRecovered:Time 24 hrs. | AverageCFUsRecovered:Time 48 hrs. |
|---|---|---|---|---|
| Haemophilusinfluenzae (ATCC10211) | Old | 219 | 186 | 87 |
| Haemophilusinfluenzae (ATCC10211) | Middle | 226 | 191 | 93 |
| Haemophilusinfluenzae (ATCC10211) | New | 223 | 191 | 91 |
| Streptococcuspneumoniae (ATCC6305) | Old | 259 | 226 | 110 |
| Streptococcuspneumoniae (ATCC6305) | Middle | 254 | 223 | 109 |
| Streptococcuspneumoniae (ATCC6305) | New | 261 | 228 | 113 |
| Staphylococcusaureus (MRSA)(ATCC 43300) | Old | 228 | 140 | 77 |
| Staphylococcusaureus (MRSA)(ATCC 43300) | Middle | 242 | 135 | 72 |
| Staphylococcusaureus (MRSA)(ATCC 43300) | New | 247 | 145 | 79 |
| Pseudomonasaeruginosa (ATCCBAA-427) | Old | 268 | 256 | 119 |
| Pseudomonasaeruginosa (ATCCBAA-427) | Middle | 276 | 258 | 128 |
| Pseudomonasaeruginosa (ATCCBAA-427) | New | 290 | 269 | 124 |
| Neisseriagonorrhoeae (ATCC43069) | Old | 267 | 136 | |
| Neisseriagonorrhoeae (ATCC43069) | Middle | 269 | 138 | |
| Neisseriagonorrhoeae (ATCC43069) | New | 281 | 146 | |
| Streptococcusagalactiae (Group BStrep) (ATCC 13813) | Old | 275 | 134 | 53 |
| Streptococcusagalactiae (Group BStrep) (ATCC 13813) | Middle | 276 | 132 | 56 |
| Streptococcusagalactiae (Group BStrep) (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 |
| Fusobacteriumnucleatum (ATCC25586) | Old | 223 | 156 | 32 |
| Fusobacteriumnucleatum (ATCC25586) | Middle | 228 | 165 | 37 |
| Fusobacteriumnucleatum (ATCC25586) | 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 #) | LotAge | AverageCFUsRecovered:Time 0 hr. | AverageCFUsRecovered:Time 24 hrs. | AverageCFUsRecovered: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 (ATCC6305) | Middle | 229 | 149 | 62 |
| pneumoniae (ATCC6305) | New | 233 | 148 | 63 |
| Staphylococcusaureus (MRSA)(ATCC 43300) | Old | 243 | 135 | 59 |
| Staphylococcusaureus (MRSA)(ATCC 43300) | Middle | 239 | 143 | 67 |
| Staphylococcusaureus (MRSA)(ATCC 43300) | New | 249 | 145 | 69 |
| Pseudomonasaeruginosa (ATCC | Old | 286 | 234 | 106 |
| Pseudomonasaeruginosa (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 #) | LotAge | AverageCFUsRecovered:Time 0 hr. | AverageCFUsRecovered:Time 24 hrs. | AverageCFUsRecovered:Time 48 hrs. |
|---|---|---|---|---|
| Neisseriagonorrhoeae (ATCC43069) | Middle | 266 | 142 | |
| Neisseriagonorrhoeae (ATCC43069) | New | 262 | 142 | |
| Streptococcusagalactiae (Group BStrep) (ATCC 13813) | Old | 285 | 118 | 52 |
| Streptococcusagalactiae (Group BStrep) (ATCC 13813) | Middle | 290 | 123 | 52 |
| Streptococcusagalactiae (Group BStrep) (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 |
| Fusobacteriumnucleatum (ATCC25586) | Old | 204 | 150 | 40 |
| Fusobacteriumnucleatum (ATCC25586) | Middle | 214 | 153 | 37 |
| Fusobacteriumnucleatum (ATCC25586) | 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 #) | LotAge | AverageCFUsRecovered:Time 0 hr. | AverageCFUsRecovered:Time 24 hrs. | AverageCFUsRecovered:Time 48 hrs. |
|---|---|---|---|---|
| Streptococcuspyogenes (ATCC19615) | Old | 249 | 247 | 135 |
| Streptococcuspyogenes (ATCC19615) | Middle | 239 | 177 | 105 |
| Streptococcuspyogenes (ATCC19615) | New | 195 | 199 | 94 |
| Peptostreptococcusanaerobius (ATCC27337) | Old | 215 | 163 | 38 |
| Peptostreptococcusanaerobius (ATCC27337) | Middle | 261 | 180 | 32 |
| Peptostreptococcusanaerobius (ATCC27337) | New | 214 | 144 | 37 |
| Propionibacteriumacnes (ATCC 6919) | Old | 257 | 163 | 42 |
| Propionibacteriumacnes (ATCC 6919) | Middle | 275 | 159 | 37 |
| Propionibacteriumacnes (ATCC 6919) | New | 230 | 137 | 34 |
| Prevotellamelaninogenica(ATCC 25845) | Old | 259 | 121 | 27 |
| Prevotellamelaninogenica(ATCC 25845) | Middle | 247 | 126 | 34 |
| Prevotellamelaninogenica(ATCC 25845) | New | 260 | 119 | 33 |
| Enterococcusfaecalis (ATCC51299) | Old | 236 | 114 | 38 |
| Enterococcusfaecalis (ATCC51299) | Middle | 252 | 108 | 35 |
| Enterococcusfaecalis (ATCC51299) | New | 237 | 113 | 43 |
| Clostridiumperfringens (Strain S-107) (ATCC 13124) | Old | 280 | 146 | 44 |
| Clostridiumperfringens (Strain S-107) (ATCC 13124) | Middle | 288 | 161 | 51 |
| Clostridiumperfringens (Strain S-107) (ATCC 13124) | New | 289 | 158 | 42 |
| Clostridiumsporogenes (ATCC3584) | Old | 245 | 97 | 39 |
| Clostridiumsporogenes (ATCC3584) | Middle | 251 | 93 | 38 |
| Clostridiumsporogenes (ATCC3584) | 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 #) | LotAge | AverageCFUsRecovered:Time 0 hr. | AverageCFUsRecovered:Time 24 hrs. | AverageCFUsRecovered:Time 48 hrs. |
|---|---|---|---|---|
| Fusobacterium | Middle | 288 | 146 | 51 |
| necrophorum (ATCC25286) | 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 #) | LotAge | AverageCFUsRecovered:Time 0 hr. | AverageCFUsRecovered:Time 24 hrs. | AverageCFUsRecovered:Time 48 hrs. |
|---|---|---|---|---|
| Streptococcuspyogenes (ATCC19615) | Old | 254 | 227 | 120 |
| Streptococcuspyogenes (ATCC19615) | Middle | 230 | 177 | 98 |
| Streptococcuspyogenes (ATCC19615) | New | 199 | 193 | 84 |
| Peptostreptococcusanaerobius (ATCC27337) | Old | 223 | 150 | 32 |
| Peptostreptococcusanaerobius (ATCC27337) | Middle | 248 | 176 | 40 |
| Peptostreptococcusanaerobius (ATCC27337) | New | 220 | 140 | 29 |
| Propionibacteriumacnes (ATCC 6919) | Old | 253 | 163 | 44 |
| Propionibacteriumacnes (ATCC 6919) | Middle | 258 | 157 | 38 |
| Propionibacteriumacnes (ATCC 6919) | New | 225 | 128 | 31 |
| Old | 261 | 122 | 31 | |
| Organism(ATCC Part #) | Lot Age | Average CFUsRecovered:Time 0 hr. | Average CFUsRecovered:Time 24 hrs. | Average CFUsRecovered:Time 48 hrs. |
| Prevotellamelaninogenica(ATCC 25845) | Middle | 252 | 119 | 39 |
| Prevotellamelaninogenica(ATCC 25845) | New | 268 | 127 | 44 |
| Enterococcusfaecalis (ATCC51299) | Old | 238 | 119 | 39 |
| Enterococcusfaecalis (ATCC51299) | Middle | 259 | 107 | 43 |
| Enterococcusfaecalis (ATCC51299) | New | 241 | 112 | 37 |
| Clostridiumperfringens (Strain S-107) (ATCC 13124) | Old | 276 | 152 | 48 |
| Clostridiumperfringens (Strain S-107) (ATCC 13124) | Middle | 283 | 164 | 53 |
| Clostridiumperfringens (Strain S-107) (ATCC 13124) | New | 280 | 159 | 56 |
| Clostridiumsporogenes (ATCC3584) | Old | 253 | 106 | 45 |
| Clostridiumsporogenes (ATCC3584) | Middle | 244 | 97 | 42 |
| Clostridiumsporogenes (ATCC3584) | 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 |
| Fusobacteriumnecrophorum (ATCC25286) | Old | 273 | 136 | 39 |
| Fusobacteriumnecrophorum (ATCC25286) | Middle | 281 | 142 | 32 |
| Fusobacteriumnecrophorum (ATCC25286) | New | 279 | 140 | 42 |
| Pseudomonasaeruginosa (ATCCBAA-427) | Old | 299 | 298 | 99 |
| Pseudomonasaeruginosa (ATCCBAA-427) | Middle | 292 | 288 | 102 |
| Pseudomonasaeruginosa (ATCCBAA-427) | New | 300 | 298 | 103 |
| Streptococcuspneumoniae(ATCC 6305) [10-4] | Old | 234 | 137 | 59 |
| Streptococcuspneumoniae(ATCC 6305) [10-4] | Middle | 227 | 147 | 67 |
| Streptococcuspneumoniae(ATCC 6305) [10-4] | New | 209 | 148 | 53 |
| Haemophilusinfluenzae (ATCC10211) | Old | 224 | 170 | 64 |
| Haemophilusinfluenzae (ATCC10211) | Middle | 216 | 172 | 71 |
| Haemophilusinfluenzae (ATCC10211) | 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 |
| Fusobacteriumnucleatum (ATCC25586) | Old | 230 | 152 | 31 |
| Fusobacteriumnucleatum (ATCC25586) | Middle | 222 | 145 | 35 |
| Fusobacteriumnucleatum (ATCC25586) | New | 202 | 116 | 22 |
| Neisseriagonorrhoeae (ATCC43069) | Old | 250 | 131 | |
| Neisseriagonorrhoeae (ATCC43069) | Middle | 270 | 138 | |
| Neisseriagonorrhoeae (ATCC43069) | New | 268 | 135 | |
| Staphylococcusaureus (MRSA)(ATCC 43300) | Old | 252 | 141 | 70 |
| Staphylococcusaureus (MRSA)(ATCC 43300) | Middle | 246 | 134 | 58 |
| Staphylococcusaureus (MRSA)(ATCC 43300) | New | 247 | 121 | 56 |
| Streptococcusagalactiae (Group BStrep) (ATCC 13813) | Old | 284 | 115 | 53 |
| Streptococcusagalactiae (Group BStrep) (ATCC 13813) | Middle | 289 | 122 | 54 |
| Streptococcusagalactiae (Group BStrep) (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 #) | LotAge | AverageCFU/mLRecovery:Time 0 hr. | AverageCFU/mLRecovery:Time 24 hrs. | AverageCFU/mLRecovery:Time 48 hrs. | Changein Log10(0-48hrs.)* |
|---|---|---|---|---|---|
| Haemophilusinfluenzae (ATCC10211) | Old | 2.84E+07 | 1.03E+07 | 3.58E+06 | -0.90 |
| Haemophilusinfluenzae (ATCC10211) | Middle | 3.00E+07 | 1.08E+07 | 4.05E+06 | -0.87 |
| Haemophilusinfluenzae (ATCC10211) | New | 3.05E+07 | 1.12E+07 | 4.08E+06 | -0.87 |
| Streptococcuspneumoniae (ATCC6305) | Old | 1.62E+07 | 5.43E+06 | 2.18E+06 | -0.87 |
| Streptococcuspneumoniae (ATCC6305) | Middle | 1.85E+07 | 5.58E+06 | 2.23E+06 | -0.92 |
| Streptococcuspneumoniae (ATCC6305) | 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 |
| Pseudomonasaeruginosa (ATCCBAA-427) | Old | 1.10E+07 | 8.80E+06 | 4.00E+06 | -0.44 |
| Pseudomonasaeruginosa (ATCCBAA-427) | Middle | 1.21E+07 | 9.90E+06 | 4.00E+06 | -0.48 |
| Pseudomonasaeruginosa (ATCCBAA-427) | New | 1.29E+07 | 1.02E+07 | 4.67E+06 | -0.44 |
| Neisseriagonorrhoeae (ATCC43069) | Old | 2.97E+07 | 2.06E+07 | -0.85 | |
| Neisseriagonorrhoeae (ATCC43069) | Middle | 3.12E+07 | 2.19E+07 | -0.77 | |
| Neisseriagonorrhoeae (ATCC43069) | 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 #) | LotAge | AverageCFU/mLRecovery:Time 0 hr. | AverageCFU/mLRecovery:Time 24 hrs. | AverageCFU/mLRecovery:Time 48 hrs. | Changein Log10(0-48hrs.)* |
|---|---|---|---|---|---|
| Streptococcusagalactiae (Group BStrep) (ATCC 13813) | Middle | 1.63E+07 | 9.24E+06 | 5.19E+06 | -0.50 |
| Streptococcusagalactiae (Group BStrep) (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 |
| Fusobacteriumnucleatum (ATCC25586) | Old | 2.26E+06 | 1.37E+06 | 3.37E+05 | -0.83 |
| Fusobacteriumnucleatum (ATCC25586) | Middle | 2.32E+06 | 1.40E+06 | 3.38E+05 | -0.84 |
| Fusobacteriumnucleatum (ATCC25586) | 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 #) | LotAge | AverageCFU/mlRecovery:Time 0 hr. | AverageCFU/mlRecovery:Time 24 hrs. | AverageCFU/mlRecovery:Time 48 hrs. | Changein Log10(0-48hrs.)* |
|---|---|---|---|---|---|
| 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 (ATCCBAA-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 | |
| Neisseriagonorrhoeae (ATCC43069) | 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 BStrep) (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 #) | LotAge | AverageCFU/mlRecovery:Time 0 hr. | AverageCFU/mlRecovery:Time 24 hrs. | AverageCFU/mlRecovery:Time 48 hrs. | Changein Log10(0-48hrs.)* |
| Streptococcuspyogenes (ATCC19615) | Old | 5.90E+06 | 2.77E+06 | 6.33E+05 | -0.97 |
| Streptococcuspyogenes (ATCC19615) | Middle | 6.30E+06 | 2.97E+06 | 8.00E+05 | -0.90 |
| Streptococcuspyogenes (ATCC19615) | New | 6.13E+06 | 2.93E+06 | 7.33E+05 | -0.92 |
| Peptostreptococcusanaerobius (ATCC27337) | Old | 1.63E+06 | 8.73E+05 | 1.53E+05 | -1.03 |
| Peptostreptococcusanaerobius (ATCC27337) | Middle | 1.62E+06 | 8.20E+05 | 1.47E+05 | -1.04 |
| Peptostreptococcusanaerobius (ATCC27337) | New | 1.57E+06 | 7.07E+05 | 1.33E+05 | -1.07 |
| Propionibacteriumacnes (ATCC 6919) | Old | 3.27E+08 | 1.27E+08 | 4.37E+07 | -0.87 |
| Propionibacteriumacnes (ATCC 6919) | Middle | 3.18E+08 | 1.17E+08 | 3.80E+07 | -0.92 |
| Propionibacteriumacnes (ATCC 6919) | New | 3.25E+08 | 1.28E+08 | 3.07E+07 | -1.02 |
| Prevotellamelaninogenica(ATCC 25845) | Old | 2.95E+08 | 7.57E+07 | 2.40E+07 | -1.09 |
| Prevotellamelaninogenica(ATCC 25845) | Middle | 2.89E+08 | 7.53E+07 | 3.17E+07 | -0.96 |
| Prevotellamelaninogenica(ATCC 25845) | New | 2.92E+08 | 9.03E+07 | 3.57E+07 | -0.91 |
| Enterococcusfaecalis (ATCC51299) | Old | 1.42E+07 | 8.00E+06 | 2.60E+06 | -0.74 |
| Enterococcusfaecalis (ATCC51299) | Middle | 1.45E+07 | 7.47E+06 | 2.83E+06 | -0.71 |
| Enterococcusfaecalis (ATCC51299) | New | 1.48E+07 | 7.43E+06 | 2.73E+06 | -0.73 |
| Clostridiumperfringens (Strain S-107) (ATCC 13124) | Old | 2.98E+07 | 1.19E+07 | 3.30E+06 | -0.96 |
| Clostridiumperfringens (Strain S-107) (ATCC 13124) | Middle | 2.91E+06 | 1.24E+07 | 4.20E+06 | -0.84 |
| Clostridiumperfringens (Strain S-107) (ATCC 13124) | New | 3.00E+07 | 1.29E+07 | 4.13E+06 | -0.86 |
| Clostridiumsporogenes (ATCC3584) | Old | 2.83E+07 | 1.75E+07 | 8.43E+06 | -0.53 |
| Clostridiumsporogenes (ATCC3584) | Middle | 2.74E+07 | 1.74E+07 | 9.07E+06 | -0.48 |
| Clostridiumsporogenes (ATCC3584) | 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 |
| Fusobacteriumnecrophorum (ATCC25286) | Old | 2.92E+07 | 1.51E+07 | 5.83E+06 | -0.70 |
| Fusobacteriumnecrophorum (ATCC25286) | Middle | 3.02E+07 | 1.52E+07 | 5.57E+06 | -0.73 |
| Fusobacteriumnecrophorum (ATCC25286) | New | 2.98E+07 | 1.56E+07 | 3.40E+06 | -0.94 |
| Pseudomonasaeruginosa (ATCCBAA-427) | Old | 1.02E+06 | 9.43E+05 | 2.70E+05 | -0.58 |
| Pseudomonasaeruginosa (ATCCBAA-427) | Middle | 1.01E+06 | 9.43E+05 | 2.87E+05 | -0.55 |
| Pseudomonasaeruginosa (ATCCBAA-427) | New | 1.03E+06 | 9.47E+05 | 2.93E+05 | -0.55 |
| Streptococcuspneumoniae (ATCC6305) | Old | 1.83E+06 | 4.70E+05 | 1.60E+05 | -1.06 |
| Streptococcuspneumoniae (ATCC6305) | Middle | 1.75E+06 | 4.83E+05 | 1.40E+05 | -1.10 |
| Streptococcuspneumoniae (ATCC6305) | New | 1.86E+06 | 4.83E+05 | 1.63E+05 | -1.06 |
| Haemophilusinfluenzae (ATCC10211) | Old | 3.07E+06 | 8.17E+05 | 3.37E+05 | -0.96 |
| Haemophilusinfluenzae (ATCC10211) | Middle | 3.13E+06 | 9.40E+05 | 3.03E+05 | -1.01 |
| Haemophilusinfluenzae (ATCC10211) | 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 |
| Fusobacteriumnucleatum (ATCC25586) | Old | 2.33E+05 | 6.43E+04 | 1.70E+04 | -1.14 |
| Fusobacteriumnucleatum (ATCC25586) | Middle | 2.25E+05 | 6.03E+04 | 1.70E+04 | -1.12 |
| Fusobacteriumnucleatum (ATCC25586) | New | 2.22E+05 | 6.67E+04 | 1.97E+04 | -1.05 |
| Fusobacteriumnucleatum (ATCC25586) | Old | 3.23E+06 | 2.13E+06 | -0.18 | |
| Fusobacteriumnucleatum (ATCC25586) | Middle | 3.21E+06 | 2.05E+06 | -0.19 | |
| Organism(ATCC Part #) | LotAge | AverageCFU/mlRecovery:Time 0 hr. | AverageCFU/mlRecovery:Time 24 hrs. | AverageCFU/mlRecovery:Time 48 hrs. | Changein Log10(0-48hrs.)* |
| Neisseriagonorrhoeae (ATCC43069) | New | 3.24E+06 | 1.99E+06 | -0.21 | |
| Staphylococcusaureus (MRSA)(ATCC 43300) | Old | 8.00E+05 | 2.60E+05 | 1.00E+05 | -1.19 |
| Staphylococcusaureus (MRSA)(ATCC 43300) | Middle | 7.47E+05 | 2.83E+05 | 1.03E+05 | -1.08 |
| Staphylococcusaureus (MRSA)(ATCC 43300) | New | 7.43E+05 | 2.73E+05 | 9.00E+04 | -1.09 |
| Streptococcusagalactiae (Group BStrep) (ATCC 13813) | Old | 1.64E+06 | 8.37E+05 | 4.77E+05 | -0.54 |
| Streptococcusagalactiae (Group BStrep) (ATCC 13813) | Middle | 1.56E+06 | 8.37E+05 | 4.20E+05 | -0.57 |
| Streptococcusagalactiae (Group BStrep) (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.
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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.
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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 #) | LotAge | AverageCFU/mlRecovery:Time 0 hr. | AverageCFU/mlRecovery:Time 24 hrs. | AverageCFU/mlRecovery:Time 48 hrs. | Changein Log10(0-48 hrs.)* |
|---|---|---|---|---|---|
| Streptococcuspyogenes (ATCC19615) | Old | 2.54E+07 | 2.27E+07 | 1.20E+07 | -0.32 |
| Streptococcuspyogenes (ATCC19615) | Middle | 2.30E+07 | 1.93E+07 | 9.70E+06 | -0.38 |
| Streptococcuspyogenes (ATCC19615) | New | 1.99E+07 | 1.77E+07 | 7.73E+06 | -0.41 |
| Peptostreptococcusanaerobius (ATCC27337) | Old | 2.23E+06 | 1.50E+06 | 3.20E+05 | -0.84 |
| Peptostreptococcusanaerobius (ATCC27337) | Middle | 2.48E+06 | 1.76E+06 | 4.03E+05 | -0.79 |
| Peptostreptococcusanaerobius (ATCC27337) | New | 2.20E+06 | 1.40E+06 | 2.93E+05 | -0.88 |
| Propionibacteriumacnes (ATCC 6919) | Old | 2.53E+08 | 1.63E+08 | 4.37E+07 | -0.76 |
| Propionibacteriumacnes (ATCC 6919) | Middle | 2.58E+08 | 1.57E+08 | 3.80E+07 | -0.83 |
| Propionibacteriumacnes (ATCC 6919) | New | 2.25E+08 | 1.28E+08 | 3.07E+07 | -0.86 |
| Prevotellamelaninogenica(ATCC 25845) | Old | 2.61E+08 | 1.22E+08 | 3.07E+07 | -0.93 |
| Prevotellamelaninogenica(ATCC 25845) | Middle | 2.52E+08 | 1.19E+08 | 3.90E+07 | -0.81 |
| Prevotellamelaninogenica(ATCC 25845) | New | 2.68E+08 | 1.27E+08 | 4.40E+07 | -0.79 |
| Enterococcusfaecalis (ATCC51299) | Old | 1.71E+07 | 5.63E+06 | 3.30E+06 | -0.71 |
| Enterococcusfaecalis (ATCC51299) | Middle | 1.58E+07 | 5.97E+06 | 3.67E+06 | -0.64 |
| Enterococcusfaecalis (ATCC51299) | New | 1.68E+07 | 5.47E+06 | 3.00E+06 | -0.75 |
| Clostridiumperfringens (Strain S-107) (ATCC 13124) | Old | 2.75E+06 | 1.43E+07 | 4.83E+06 | -0.76 |
| Clostridiumperfringens (Strain S-107) (ATCC 13124) | Middle | 2.69E+07 | 1.43E+07 | 4.50E+06 | -0.78 |
| Clostridiumperfringens (Strain S-107) (ATCC 13124) | New | 2.78E+07 | 1.46E+07 | 4.20E+06 | -0.82 |
| Clostridiumsporogenes (ATCC3584) | Old | 2.62E+07 | 1.42E+07 | 5.87E+06 | -0.65 |
| Clostridiumsporogenes (ATCC3584) | Middle | 2.50E+07 | 1.34E+07 | 5.07E+06 | -0.69 |
| Clostridiumsporogenes (ATCC3584) | 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 |
| Fusobacteriumnecrophorum (ATCC25286) | Old | 2.92E+07 | 1.48E+07 | 5.57E+06 | -0.72 |
| Fusobacteriumnecrophorum (ATCC25286) | Middle | 2.78E+07 | 1.44E+07 | 5.23E+06 | -0.72 |
| Fusobacteriumnecrophorum (ATCC25286) | New | 2.72E+07 | 1.59E+07 | 4.60E+06 | -0.77 |
| Old | 1.26E+06 | 1.68E+06 | 1.22E+06 | -0.53 |
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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 #) | LotAge | AverageCFU/mlRecovery:Time 0 hr. | AverageCFU/mlRecovery:Time 24 hrs. | AverageCFU/mlRecovery:Time 48 hrs. | Changein Log10(0-48hrs.)* |
|---|---|---|---|---|---|
| Pseudomonasaeruginosa (ATCCBAA-427) | Middle | 1.35E+06 | 1.68E+06 | 1.19E+06 | -0.51 |
| Pseudomonasaeruginosa (ATCCBAA-427) | New | 1.16E+06 | 1.55E+06 | 1.10E+06 | -0.53 |
| Streptococcuspneumoniae (ATCC6305) | Old | 2.34E+06 | 1.37E+06 | 5.60E+05 | -0.62 |
| Streptococcuspneumoniae (ATCC6305) | Middle | 2.27E+06 | 1.47E+06 | 6.67E+05 | -0.53 |
| Streptococcuspneumoniae (ATCC6305) | New | 2.09E+06 | 1.47E+06 | 5.27E+05 | -0.60 |
| Haemophilusinfluenzae (ATCC10211) | Old | 2.24E+06 | 1.70E+06 | 6.43E+05 | -0.54 |
| Haemophilusinfluenzae (ATCC10211) | Middle | 2.16E+06 | 1.72E+06 | 7.10E+05 | -0.48 |
| Haemophilusinfluenzae (ATCC10211) | 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 |
| Fusobacteriumnucleatum (ATCC25586) | Old | 2.30E+05 | 1.52E+05 | 3.13E+04 | -0.87 |
| Fusobacteriumnucleatum (ATCC25586) | Middle | 2.22E+05 | 1.45E+05 | 3.47E+04 | -0.81 |
| Fusobacteriumnucleatum (ATCC25586) | New | 2.02E+05 | 1.16E+05 | 2.40E+04 | -0.93 |
| Neisseriagonorrhoeae (ATCC43069) | Old | 2.60E+06 | 9.40E+05 | -0.44 | |
| Neisseriagonorrhoeae (ATCC43069) | Middle | 2.80E+06 | 9.43E+05 | -0.47 | |
| Neisseriagonorrhoeae (ATCC43069) | New | 2.92E+06 | 9.67E+05 | -0.48 | |
| Staphylococcusaureus (MRSA)(ATCC 43300) | Old | 2.05E+06 | 1.92E+06 | 8.43E+05 | -0.39 |
| Staphylococcusaureus (MRSA)(ATCC 43300) | Middle | 2.20E+06 | 1.99E+06 | 7.63E+05 | -0.46 |
| Staphylococcusaureus (MRSA)(ATCC 43300) | New | 2.20E+06 | 1.95E+06 | 7.83E+05 | -0.45 |
| Streptococcusagalactiae (Group BStrep) (ATCC 13813) | Old | 1.72E+06 | 7.80E+05 | 4.47E+05 | -0.58 |
| Streptococcusagalactiae (Group BStrep) (ATCC 13813) | Middle | 1.37E+06 | 5.10E+05 | 3.77E+05 | -0.56 |
| Streptococcusagalactiae (Group BStrep) (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 Stabilitytests in real time | TestInterval | 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 estimationof turbidity | Monthly | Random tubes from independent lots stored at room temperatures(20–25°C) passed visual inspection with testing time ranging fromtime zero through 18 months. |
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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) Viscositymeasurement | 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 zerothrough 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.
§ 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.