ARX Viral Transport Media Collection & Transport System (ARX-VTM) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. The ARX-VTM is a culture-based media that is intended to be used in the laboratory to perform viral culture or diagnostic assays for viruses including, Influenza A, Parainfluenza type 3, Coronavirus OC43, Respiratory Syncytial Virus (RSV) A, Herpes Simplex virus 1 & 2, Echovirus, and Cytomegalovirus.

Device Description

ARX Viral Transport Media Collection and Transport System (ARX-VTM) is a specialized systems for collecting and transporting viruses at 2-8 ºC or 20-25 ºC. The ARX-VTM is for use in laboratories to aid in the diagnosis of infections, especially when there is a delay between specimen collection and processing for up to 72 hrs. ARX Viral Transport Media Collection & Transport System (ARX-VTM) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. The ARX-VTM is a culturebased media that is intended to be used in the laboratory to perform viral culture or diagnostic assays for viruses including, Influenza A, Parainfluenza type 3, Coronavirus OC43, Respiratory Syncytial Virus (RSV) A, Herpes Simplex virus 1 & 2, Echovirus, and Cytomegalovirus.

Device Specifications: The ARX-VTM contains a non-propagating media supplied in a polypropylene (PP) tube individually with 1 or 3 mL of transport medium and as a kit. The kit contains a PP tube with 1 or 3 mL of transport medium and a sterile peel pouch containing a nylon flocked swab applicator for collecting specimens. Nylon flocked swabs are available in various score points and configurations to facilitate specimen collection from various anatomical sites.

AI/ML Overview

The provided document describes the ARX Viral Transport Media Collection and Transport System (ARX-VTM) and its performance characteristics for viral recovery.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Viral Recovery	Any change of virus titer within one log (+/- 90%) from the baseline (time point 0) was considered acceptable. This applies to recovery at both 2-8°C and 25-30°C for multiple viruses.
Storage Temperature: 2-8°C (72 hours)
Cytomegalovirus	-29.91% (within +/-90%)
Coronavirus OC43	-20.29% (within +/-90%)
Echovirus Type 30	-13.54% (within +/-90%)
Herpes Simplex Virus Type 1	-29.74% (within +/-90%)
Herpes Simplex Virus Type 2	-29.78% (within +/-90%)
Influenza A H3N2	26.89% (within +/-90%)
Parainfluenza Type 3	-36.19% (within +/-90%)
Respiratory Syncytial Type A	-41.66% (within +/-90%)
Storage Temperature: 25-30°C (72 hours)
Cytomegalovirus	-34.58% (within +/-90%)
Coronavirus OC43	-27.68% (within +/-90%)
Echovirus Type 30	-19.81% (within +/-90%)
Herpes Simplex Virus Type 1	-36.23% (within +/-90%)
Herpes Simplex Virus Type 2	-33.85% (within +/-90%)
Influenza A H3N2	8.63% (within +/-90%)
Parainfluenza Type 3	-46.93% (within +/-90%)
Respiratory Syncytial Type A	23.07% (within +/-90%)
Shelf-Life
Visual Inspection (turbidity, color) at 20 months	Clear, no cloudy, no precipitation, pink color maintained.
pH (acceptable range: 7.4 ± 0.4) at 20 months	All results acceptable.
Osmolarity (acceptable range: 290 ± 30 mOsm/Kg) at 20 months	All results acceptable.

2. Sample size used for the test set and the data provenance

Sample Size for Viral Recovery: For each virus and each temperature condition (2-8°C and 25-30°C), tests were conducted with swabs in triplicate at time points 0, 24, 48, and 72 hours. While the exact number of swabs per time point isn't explicitly stated beyond "in triplicate," this would mean at least 3 swabs per virus per time point per temperature. The total 'n' would be 8 viruses * 2 temperatures * 4 time points * 3 replicates = 192 samples (excluding additional replicates for baseline).
Sample Size for Shelf-Life: Three lots of ARX-VTM samples were tested, with duplicate samples from each lot for visual inspection, pH, and osmolarity.
Data Provenance: The document does not specify the country of origin of the data. The study appears to be a prospective laboratory study, where the performance of the ARX-VTM was measured under controlled conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ground truth for viral recovery was established via visual enumeration of fluorescent foci units (FFU) by researchers. The document does not specify the number or qualifications of experts involved in this enumeration. It appears to be a standard laboratory method rather than expert consensus on clinical cases.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set, as the ground truth was established through quantitative laboratory measurements (FFU counts). Adjudication methods like "2+1" typically apply to subjective assessments requiring multiple readers, which is not the case here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. The device is a viral transport medium, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a viral transport medium, not an algorithm or software. The performance assessment focused on the medium's ability to maintain viral viability.

7. The type of ground truth used

The type of ground truth used for viral recovery studies was quantitative laboratory measurement of viral viability, specifically the visual enumeration of fluorescent foci units (FFU) after inoculation into monolayer cells and immunostaining. For shelf-life, the ground truth involved quantitative measurements of pH and osmolarity, and qualitative visual inspection.

8. The sample size for the training set

This is not applicable. The ARX-VTM is a physical medical device (transport medium) and not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reason as above; there is no training set for this type of device.

Summary

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March 19, 2024

ARX Sciences, Inc. Chad Werts President 160 Lawrence Bell Drive Suite 120 Amherst, New York 14221

Re: K231843

Trade/Device Name: ARX Viral Transport Media Collection and Transport System Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: Class I, reserved Product Code: JSM Dated: June 12, 2023 Received: June 22, 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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).

Sincerelv.

Ribhi Shawar -S

Ribhi Shawar, Ph.D. (ABMM) Chief, General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K231843

Device Name

ARX Viral Transport Media Collection and Transport System

Indications for Use (Describe)

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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ARX Sciences Viral Transport Media Collection and Transport System (ARX-VTM) 510(k) Summary

March 19, 2024

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:

Applicant name	ARX Sciences, Inc.160 Lawrence Bell Drive Suite 120, Amherst, NY 14221USA
Contact Person	Chad Werts, President, ARX Sciences, Inc.
Telephone	+1-(716) 783-6704
Trade Name	ARX Viral Transport Media Collection and TransportSystem (ARX-VTM)
Common Name	Transport culture medium
Regulation	21 CFR 866.2390
Class	Class I
Product Code	JSM
Predicate Device	K212856

Device Description:

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ARX Sciences, Inc. 160 Lawrence Bell Drive, Suite 120 Amherst, NY 14221

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REF	PRODUCT DESCRIPTION		PACKAGING
	TUBE	SWAB
AR-071	1 mL of ARX-VTM mediumin 13x90 mm screw-captube with internal shapedconical bottom.	NA	50 tubes per package10 x 50 tubes per box
AR-071-N	1 mL of ARX-VTM mediumin 13x90 mm screw-captube with internal shapedconical bottom	One NasopharyngealTest Swabwith breaking point	50 kits per package10 x 50 kits per box
AR-071-O	1 mL of ARX-VTM mediumin 13x90 mm screw-captube with internal shapedconical bottom.	One OropharyngealTest Swabwith breaking point	50 kits per package10 x 50 kits per box
AR-103	3 mL of ARX-VTM mediumin 16x110 mm screw-captube with internal shapedconical bottom.	NA	50 tubes per package10 x 50 tubes per box
AR-103-N	3 mL of ARX-VTM mediumin 16x110 mm screw-captube with internal shapedconical bottom.	One NasopharyngealTest Swabwith breaking point	50 kits per package10 x 50 kits per box
AR-103-O	3 mL of ARX-VTM mediumin 16x100 mm screw-captube with internal shapedconical bottom	One OropharyngealTest Swabwith breaking point	50 kits per package10 x 50 kits per box

Table 1: The ARX-VTM is available in the following specifications:

ARX-VTM composition:

The ARX-VTM contains antimicrobial agents to inhibit overgrowth of bacteria, fungi, and yeasts; Hank's Balanced Salt Solution (HBSS) enriched with proteins and sugars for stabilization; and a buffer system to maintain neutral pH. All raw materials used in the manufacture of ARX Viral Transport Media System are qualified before use. Every batch of ARX Viral Transport Media is tested prior to release for pH, osmolarity, turbidity and absence of bacteria growth.

Indications of Use

The ARX Viral Transport Media Collection & Transport System (ARX-VTM) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. The ARX-VTM is a culture-based media that is intended to be used in the laboratory to perform viral culture or diagnostic assays for viruses including, Influenza A, Parainfluenza type 3, Coronavirus OC43, Respiratory Syncytial Virus (RSV) A, Herpes Simplex virus 1& 2, Echovirus, and Cytomegalovirus.

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ARX Sciences, Inc. 160 Lawrence Bell Drive, Suite 120 Amherst, NY 14221

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Sterilization

The ARX-VTM kit is not claimed to be sterile nor is it intended to be sterilized by the end user. To decrease the chance of contamination the media uses specific manufacturing steps including sterilization of the PP tubes. The media is filtered using a 0.22 um sterile fiber membrane and then is aseptically filled into the pre-sterilized tubes. ARX-VTM was then validated by a quality control process which evaluates the absence of growth of bacteria and fungi by spreading a 0.1mL of the filtered media on nutrient agar media plates and incubated at 35°C ± 2°C for 24-48 hours. No growth on any of the plates tested was observed.

Performance Characteristics

The performance characteristics of ARX Viral Transport Media System were determined using culture-based recovery studies for the following viruses: Coronavirus, Cytomegalovirus (CMV), Echovirus Type 30, Herpes Simplex Virus Type 1 (HSV-1), Herpes Simplex Virus Type 2 (HSV-2), Influenza A, Parainfluenza 3, and Respiratory Syncytial Virus (RSV). Dilutions of the virus stock suspensions were prepared in clinical matrix and 100 µL was inoculated onto swabs in triplicate. The swabs were transferred into the transport medium and held at both 2-8°C and room temperature (25-30°C). The dilution used for each target was predetermined by demonstrating ~~40 to~~50% infection via FFU after 24-48 hours in culture.

At time points following inoculation into VTM (0, 24, 48, and 72), each sample was mixed thoroughly, and an aliquot of the suspension was inoculated into monolayer cells cultured with media in 96-well plates. After 24-48 hours of inoculation, the cells were washed, fixed, and immunostained by fluorescein isothiocyanate (FITC)-labeled antibodies for each target virus. The virus titer was determined by visual enumeration of fluorescent foci units (FFU) of each target virus. Table 2 below exhibits the viral recovery performance of the ARX-VTM at 2-8°C. Table 3 below exhibits the viral recovery performance of the ARX-VTM at 25-30°C. Any change of virus titer that was within one log (+/-90%) from the baseline (time point 0) was considered acceptable.

Test Strain	AverageRecovery inFoci count/mL(×104 FociCounts/mL)	Percent Changes in viral recovery from thebaseline (T= 0 hr.) at 2-8°C(-ve indicates reduction)
	0 h	24 h	48 h	72 h
Cytomegalovirus	3.52E+04	-0.34%	-5.65%	-29.91%
Coronavirus OC43	1.93E+04	13.53%	-4.90%	-20.29%
Echovirus Type 30	4.29E+04	2.27%	-0.60%	-13.54%
Herpes Simplex Virus Type 1	3.06E+04	-1.26%	-15.39%	-29.74%

Table 2: Viral recovery performance of ARX-VTM at 2-8°C

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Herpes Simplex Virus Type 2	3.71E+04	-18.51%	-23.41%	-29.78%
Influenza A H3N2	3.39E+04	36.00%	61.69%	26.89%
Parainfluenza Type 3	3.61E+04	61.16%	9.21%	-36.19%
Respiratory Syncytial Type A	1.12E+04	31.29%	-24.14%	-41.66%

Table 3: Viral recovery performance of ARX-VTM at 25-30°C

Test Strain	AverageRecovery inFoci count/mL(×104 FociCounts/mL)	Percent Changes in viral recovery from thebaseline (T= 0 hr.) at 25-30°C(-ve indicates reduction)
	0 h	24 h	48 h	72 h
Cytomegalovirus	3.52E+04	4.85%	-24.86%	-34.58%
Coronavirus OC43	1.93E+04	12.82%	-6.68%	-27.68%
Echovirus Type 30	4.29E+04	10.16%	-5.16%	-19.81%
Herpes Simplex Virus Type 1	3.06E+04	-3.33%	-12.47%	-36.23%
Herpes Simplex Virus Type 2	3.71E+04	-13.19%	-23.06%	-33.85%
Influenza A H3N2	3.39E+04	32.50%	45.29%	8.63%
Parainfluenza Type 3	3.61E+04	41.75%	-16.68%	-46.93%
Respiratory Syncytial Type A	1.12E+04	98.71%*	61.86%	23.07%

Considered acceptable because subsequent timepoints, i.e., 48 h and 72 h time points showed < 90% increase.

Shelf Life:

To evaluate Shelf-life, three lots of ARX-VTM samples were tested and visually examined for real-time aging to 20 months. The lots of media were stored at 2-8°C or room temperature (25-30°C). Duplicate samples from each lot were visually inspected for turbidity (the appearance of the product is expected to be clear (i.e., no turbidity, not cloudy, and no precipitation) and maintains a pink color (i.e., no color change from pink to yellow). The media lots were tested

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ARX Sciences, Inc. 160 Lawrence Bell Drive, Suite 120 Amherst, NY 14221

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for pH (acceptable range: 7.4 ± 0.4) and osmolarity (acceptable range: 290 ± 30 mOsm/Kg). All results were acceptable and support the claim that the ARX-VTM is stable for up to 20 months.

Substantial Equivalence

In-vitro testing was performed and the results for ARX-VTM was compared to that of the predicate device, iClean Viral Transport System (K212856). The results demonstrated that ARX Viral Transport Media Collection & Transport System possesses the same technological characteristics necessary to fulfill the intended use. Based on the similarities in design, manufacturing, indications for use and fundamental scientific technology, the subject device is comparable to the predicate device and does not introduce any new risks of safety or efficacy. The ARX Viral Transport Media System is substantially equivalent to the predicate device for the primary intended use of microbiological sample collection and transport. Below is a summary of comparison table between the ARX-VTM and the predicate device, K212856:

Device &PredicateDevice(s):	Subject Device: K231483	Predicate: K212856
Device TradeName	ARX Viral Transport MediaCollection and TransportSystem (ARX-VTM)	iClean Viral TransportSystem (VTM-RT Kit)
Device ProductCode andClassification	JSM, Class I	JSM, Class I
General DeviceCharacteristicSimilarities	-	-
IntendedUse/Indicationsfor Use	The ARX Viral TransportMedia Collection &Transport System (ARX-VTM)is intended for the collectionand transport of clinicalspecimens containing virusesfrom the collection site tothe testing laboratory. TheARX-VTM is a culture-basedmedia that is intended to beused in the laboratory toperform viral culture ordiagnostic assays for virusesincluding, Influenza A,Parainfluenza type 3,Coronavirus OC43,Respiratory Syncytial Virus(RSV) A, Herpes Simplex virus1& 2, Echovirus, andCytomegalovirus.	iClean Viral TransportSystem (VTM-RT Kit) isintended for thecollection andtransport of clinicalspecimens containingrespiratory viruses,Chlamydiae, orMycoplasma hominisfrom the collectionsite to the testinglaboratory. Thecollection system is aculture-based mediathat is intended to beused with standardlaboratoryexamination, cultureor with other assaysthat utilize stablerecoverable infectiousviral particles orbacteria.
StorageTemperature	2-8ºC and 20-25ºC	20-25°C
Tube Material	Plastic Screw-Cap Tube	Same
Single Use Device	Yes	Same
General DeviceCharacteristicDifferences	-	-
MediaFormulation	* Fetal Bovine Serum* Gentamicin* Amphotericin B* Hanks Balanced SaltSolution (HBSS)	* Hanks Balanced SaltSolution (HBSS)* Bovine SerumAlbumin (BSA)* Gentamicin Sulfate* Amphotericin B* Colistin* L-Glutamic acid* HEPES buffer* Phenol Red
Shelf Life	20 months	12 months
Storage Time	Specimen should be processed within 72 hours	Specimen should be processed within 48 hours
Supported Strains	* Cytomegalovirus* Echovirus Type 30* Herpes Simplex Virus Type 1* Herpes Simplex Virus Type 2* Influenza A* Parainfluenza 3* Respiratory Syncytial Virus* Coronavirus	* Adenovirus* Cytomegalovirus* Echovirus Type 30* Herpes Simplex Virus Type 1* Herpes Simplex Virus Type 2* Influenza A* Parainfluenza 3* Respiratory Syncytial Virus* Chlamydia pneumoniae* Chlamydia trachomatis* Mycoplasma hominis

Table 4: Comparison with the Predicate Device

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Conclusion

The ARX Viral Transport Media Collection & Transport System (ARX-VTM) demonstrated recovery of the following tested viruses (Influenza A, Parainfluenza type 3, Coronavirus OC43, Respiratory Syncytial Virus (RSV) A, Herpes Simplex virus 1& 2, Echovirus, and Cytomegalovirus) with an acceptable culture recovery rate when stored at 2-8°C and 20-25°C for up to 72 hours.

Based on devices technological features, intended use and performances, the ARX Viral Transport Media Collection & Transport System (ARX-VTM) is substantially equivalent to the legally marketed predicate device, iClean Viral Transport System (K212856).

Regulation Number and Section

§ 866.2390 Transport culture medium.

(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).