(271 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of the transport media and collection system, with no mention of computational analysis or algorithms.
No
The device is intended for the collection and transport of clinical specimens for diagnostic purposes, not for treating any condition or disease.
No
This device is a transport media for clinical specimens containing viruses. While it is used in the laboratory to aid in the diagnosis of infections by facilitating viral culture or diagnostic assays, the device itself is not performing the diagnostic function (e.g., providing a diagnosis or detecting the presence of a disease marker). It is an accessory to diagnostic procedures.
No
The device description clearly states it is a "specialized systems for collecting and transporting viruses" and includes physical components like "culture-based media supplied in a polypropylene (PP) tube" and a "nylon flocked swab applicator." This indicates it is a physical medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to be used in the laboratory to perform viral culture or diagnostic assays for viruses". This directly aligns with the definition of an in vitro diagnostic product, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description further clarifies that the ARX-VTM is "for use in laboratories to aid in the diagnosis of infections".
- Performance Studies: The performance studies described involve testing the ability of the media to maintain the viability of viruses for subsequent diagnostic testing (viral culture).
The device is designed to collect and transport specimens for in vitro analysis (viral culture or diagnostic assays) to aid in the diagnosis of infections. This is the core function of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
JSM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nylon flocked swabs are available in various score points and configurations to facilitate specimen collection from various anatomical sites.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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 to50% 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.
Key results:
At 2-8°C:
Cytomegalovirus: 0 h (3.52E+04), 24 h (-0.34%), 48 h (-5.65%), 72 h (-29.91%)
Coronavirus OC43: 0 h (1.93E+04), 24 h (13.53%), 48 h (-4.90%), 72 h (-20.29%)
Echovirus Type 30: 0 h (4.29E+04), 24 h (2.27%), 48 h (-0.60%), 72 h (-13.54%)
Herpes Simplex Virus Type 1: 0 h (3.06E+04), 24 h (-1.26%), 48 h (-15.39%), 72 h (-29.74%)
Herpes Simplex Virus Type 2: 0 h (3.71E+04), 24 h (-18.51%), 48 h (-23.41%), 72 h (-29.78%)
Influenza A H3N2: 0 h (3.39E+04), 24 h (36.00%), 48 h (61.69%), 72 h (26.89%)
Parainfluenza Type 3: 0 h (3.61E+04), 24 h (61.16%), 48 h (9.21%), 72 h (-36.19%)
Respiratory Syncytial Type A: 0 h (1.12E+04), 24 h (31.29%), 48 h (-24.14%), 72 h (-41.66%)
At 25-30°C:
Cytomegalovirus: 0 h (3.52E+04), 24 h (4.85%), 48 h (-24.86%), 72 h (-34.58%)
Coronavirus OC43: 0 h (1.93E+04), 24 h (12.82%), 48 h (-6.68%), 72 h (-27.68%)
Echovirus Type 30: 0 h (4.29E+04), 24 h (10.16%), 48 h (-5.16%), 72 h (-19.81%)
Herpes Simplex Virus Type 1: 0 h (3.06E+04), 24 h (-3.33%), 48 h (-12.47%), 72 h (-36.23%)
Herpes Simplex Virus Type 2: 0 h (3.71E+04), 24 h (-13.19%), 48 h (-23.06%), 72 h (-33.85%)
Influenza A H3N2: 0 h (3.39E+04), 24 h (32.50%), 48 h (45.29%), 72 h (8.63%)
Parainfluenza Type 3: 0 h (3.61E+04), 24 h (41.75%), 48 h (-16.68%), 72 h (-46.93%)
Respiratory Syncytial Type A: 0 h (1.12E+04), 24 h (98.71%), 48 h (61.86%), 72 h (23.07%)
Key Metrics
Recovery in Foci count/mL and Percent Changes in viral recovery from the baseline.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
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)
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.
| 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 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 below the logo in a smaller font. The logo is simple and modern, and the colors are bold and eye-catching.
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 14221
USA |
|------------------|-----------------------------------------------------------------------------------|
| Contact Person | Chad Werts, President, ARX Sciences, Inc. |
| Telephone | +1-(716) 783-6704 |
| Trade Name | ARX Viral Transport Media Collection and Transport
System (ARX-VTM) |
| Common Name | Transport culture medium |
| Regulation | 21 CFR 866.2390 |
| Class | Class I |
| Product Code | JSM |
| Predicate Device | K212856 |
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.
4
ARX Sciences, Inc. 160 Lawrence Bell Drive, Suite 120 Amherst, NY 14221
Image /page/4/Picture/1 description: The image shows a logo for ARX Sciences. The logo is a stylized letter "A" in blue, with two white vertical lines in the center that converge at the top. There are two red shapes on either side of the white lines. Below the logo, the words "ARX SCIENCES" are written in a simple, sans-serif font.
| REF | PRODUCT DESCRIPTION | PACKAGING | |
|---|---|---|---|
| TUBE | SWAB | ||
| AR-071 | 1 mL of ARX-VTM medium | ||
| in 13x90 mm screw-cap | |||
| tube with internal shaped | |||
| conical bottom. | NA | 50 tubes per package | |
| 10 x 50 tubes per box | |||
| AR-071-N | 1 mL of ARX-VTM medium | ||
| in 13x90 mm screw-cap | |||
| tube with internal shaped | |||
| conical bottom | One Nasopharyngeal | ||
| Test Swab | |||
| with breaking point | 50 kits per package | ||
| 10 x 50 kits per box | |||
| AR-071-O | 1 mL of ARX-VTM medium | ||
| in 13x90 mm screw-cap | |||
| tube with internal shaped | |||
| conical bottom. | One Oropharyngeal | ||
| Test Swab | |||
| with breaking point | 50 kits per package | ||
| 10 x 50 kits per box | |||
| AR-103 | 3 mL of ARX-VTM medium | ||
| in 16x110 mm screw-cap | |||
| tube with internal shaped | |||
| conical bottom. | NA | 50 tubes per package | |
| 10 x 50 tubes per box | |||
| AR-103-N | 3 mL of ARX-VTM medium | ||
| in 16x110 mm screw-cap | |||
| tube with internal shaped | |||
| conical bottom. | One Nasopharyngeal | ||
| Test Swab | |||
| with breaking point | 50 kits per package | ||
| 10 x 50 kits per box | |||
| AR-103-O | 3 mL of ARX-VTM medium | ||
| in 16x100 mm screw-cap | |||
| tube with internal shaped | |||
| conical bottom | One Oropharyngeal | ||
| Test Swab | |||
| with breaking point | 50 kits per package | ||
| 10 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
Image /page/5/Picture/1 description: The image shows a logo for ARX Sciences. The logo is a stylized letter "A" in blue, with a white and red design inside the "A". Below the logo, the words "ARX SCIENCES" are written in a simple, sans-serif font. The logo appears to be for a company in the science or technology field.
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 to50% 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 | Average
Recovery in
Foci count/mL
(×104 Foci
Counts/mL) | Percent Changes in viral recovery from the
baseline (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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Image /page/6/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 a sans-serif font below the logo. The logo is simple and modern.
| 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 | Average
Recovery in
Foci count/mL
(×104 Foci
Counts/mL) | Percent Changes in viral recovery from the
baseline (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