(273 days)
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No
The device is a viral transport medium, a physical substance used for specimen collection and transport. The description focuses on its composition, packaging, and performance in preserving viral viability, with no mention of computational analysis, algorithms, or AI/ML techniques.
No
The device is a Viral Transport Medium (VTM) intended for the collection and transport of clinical specimens for the preservation of viral agents, not for treating or diagnosing a disease directly in a patient.
No
This device is a transport medium for specimens, used to preserve viral agents from the collection site to the testing laboratory. It is intended for use in standard laboratory procedures for virus culture and diagnostic assays, but it is not itself a diagnostic device. It facilitates the diagnostic process by ensuring sample integrity but does not perform the diagnosis.
No
The device is a physical transport medium and associated hardware (tube, swab), not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "collection and transport of clinical specimens for the preservation of viral agents... from the collection site to the testing laboratory" and is intended to be used in "standard laboratory procedures for virus culture and diagnostic assays". This clearly indicates its role in the diagnostic process.
- Device Description: It's described as a "non-propagating culture-based transport media used for the collection and transport of specimens suspected of containing viruses... for downstream laboratory test methods." This further reinforces its use in preparing samples for diagnostic testing.
- Performance Studies: The document details performance studies related to "Viral Recovery Performance," which directly assesses the device's ability to maintain the viability of viruses for subsequent diagnostic testing. The metrics used (viral recovery, TCID50/mL) are relevant to evaluating the performance of a diagnostic aid.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K042970; Copan Universal Transport Medium (UTM-RT) System) strongly suggests that this device is being compared to other legally marketed IVDs.
In summary, the device's purpose is to facilitate the collection and transport of specimens for laboratory diagnostic testing, which is the core function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Hardy Diagnostics' Viral Transport Medium (VTM) is intended for the collection and transport of clinical specimens for the preservation of viral agents influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory. Hardy Diagnostics' VTM is a culture-based media that is intended to be used in standard laboratory procedures for virus culture and diagnostic assays that utilize stable recoverable infectious viral particles.
Product codes (comma separated list FDA assigned to the subject device)
JSM
Device Description
Hardy Diagnostics' Viral Transport Medium (VTM) is a non-propagating culture-based transport media used for the collection and transport of specimens suspected of containing viruses including Influenza A, Influenza B, Adenovirus, and Echovirus for downstream laboratory test methods. The VTM includes a screw-cap polypropylene tube with skirted conical bottom containing 3mL of transport medium. VTM tubes can be supplied alone, or in a kit format with a mini-tip flocked swab in a sterile peel-pouch. Hardy Diagnostics' VTM is not claimed to be sterile nor is it intended to be sterilized by the end user. Hardy Diagnostics' VTM vials are single use devices.
The product is supplied in multiple configurations described in more detail in table 1 below: tubes alone, or in a kit format with a swab.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Shelf-life Stability:
- Study type: Real-time ageing studies
- Sample size: Three lots of VTM
- Data: Media lots held at 2-8°C and 20-25°C for 12 months.
- Key results: All results met the study acceptance criteria and support a shelf-life stability of Hardy Diagnostics' VTM for up to 12 months or 365 days.
Viral Recovery Performance:
- Study type: Viral recovery study
- Data: Known virus concentration spiked into pooled negative clinical matrix, inoculated into a minimum of three lots of Viral Transport Medium, and held at 2-8°C and 20-25°C for 0, 24, and 48 hours. Aliquots pulled at 0, 24, and 48 hours, serially diluted, and inoculated in triplicate into susceptible host cell line.
- Key results: Viral titer determined by calculating the fifty-percent tissue culture infective dose (TCID50/mL) using the Reed-Muench method. Results considered acceptable if the average viral recovery for each time point and storage condition demonstrate any percent changes within ±90% (i.e., 1 log change) from baseline (T=0). The study was conducted for Influenza A, Influenza B, Echovirus, and Adenovirus. Viral recovery study results support the recovery of Influenza A, Influenza B, Adenovirus, and Echovirus when stored at 2-8°C and 20-25°C for up to 48 hours from sample collection.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.2390 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 2, 2024
Hardy Diagnostics Anna Klavins Senior R&D and Performance Studies Manager 1430 West McCoy Lane Santa Maria, California 93455
Re: K233534
Trade/Device Name: Viral Transport Medium Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: Class I, reserved Product Code: JSM Dated: June 25, 2024 Received: June 25, 2024
Dear Anna Klavins:
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).
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
1
K233534 - Anna Klavins
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 (OS) 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 medical devices and radiation-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., 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
2
Indications for Use
510(k) Number (if known) K233534
Device Name Viral Transport Medium
Indications for Use (Describe)
Hardy Diagnostics' Viral Transport Medium (VTM) is intended for the collection and transport of clinical specimens for the preservation of viral agents influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory. Hardy Diagnostics' VTM is a culture-based media that is intended to be used in standard laboratory procedures for virus culture and diagnostic assays that utilize stable recoverable infectious viral particles.
| 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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3
510(k) Summarv
July 31, 2024
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
I. General Information
Applicant Name: Hardy Diagnostics 1430 W. McCoy Lane Santa Maria, CA 93455
Contact Person: Anna Klavins Senior Technical Services and R&D Manager Phone: 800-266-2222 x5752 E-mail: KlavinsA@hardydiagnostics.com
II. Device Information
Device Trade Name: Viral Transport Medium Common Name: Transport culture medium Classification Name: Culture Media, Non-Propagating Transport Regulation Number: 21 CFR 866.2390 Class: Class I Product Code: JSM
III. Predicate Device
Copan Universal Transport Medium (UTM-RT) System (K042970)
IV. Device Description
Hardy Diagnostics' Viral Transport Medium (VTM) is a non-propagating culture-based transport media used for the collection and transport of specimens suspected of containing viruses including Influenza A, Influenza B, Adenovirus, and Echovirus for downstream laboratory test methods. The VTM includes a screw-cap polypropylene tube with skirted conical bottom containing 3mL of transport medium. VTM tubes can be supplied alone, or in a kit format with a mini-tip flocked swab in a sterile peel-pouch. Hardy Diagnostics' VTM is not claimed to be sterile nor is it intended to be sterilized by the end user. Hardy Diagnostics' VTM vials are single use devices.
The product is supplied in multiple configurations described in more detail in table 1 below: tubes alone, or in a kit format with a swab.
4
| Catalog
| Number | Description | Quantity |
|---|---|---|
| R99 | VTM, 16×100mm polypropylene tube, 3mL fill | 20 tubes/box |
| R64BX | VTM, 13×80mm polypropylene tube, 3mL fill | 100 tubes/box |
| TPV50 | TransPRO VTM System, single 16×100mm polypropylene | |
| tube, 3mL fill with individually wrapped, sterile, mini-tip, | ||
| flocked swab with 80mm breakpoint. | 50 each/box |
Table 1. List of Configurations: Hardy Diagnostics' VTM
V. Composition of Hardy Diagnostics' VTM
The VTM consists of Hank's Balanced Salt Solution, fetal bovine serum, sucrose to stabilize viral agents, along with Amphotericin B and Gentamicin Sulfate to inhibit bacterial and fungal contaminants. Hardy Diagnostics' VTM also contains a pH indicator (phenol red) to provide a visual check on the medium's pH. VTM appears translucent and light peach in color.
VI. Intended Use/Indications for Use
Hardy Diagnostics' Viral Transport Medium (VTM) is intended for the collection and transport of clinical specimens for the preservation of viral agents including, Influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory. Hardy Diagnostics VTM is a culture-based media that is intended to be used in standard laboratory procedures for virus culture and diagnostic assays that utilize stable recoverable infectious viral particles.
VII. Substantial Equivalence Comparison
The following table demonstrates the substantial equivalence comparison of Hardy Diagnostics' Viral Transport Medium to Copan Universal Transport Medium (UTM-RT) System:
| New Device | Predicate Device | |
|---|---|---|
| Hardy Diagnostics' Viral | ||
| Transport Medium | Copan Universal Transport | |
| Medium (UTM-RT) System | ||
| K233534 | K042970 | |
| Device Similarities | ||
| Device Product Code | ||
| and Classification | JSM, Class 1 | JSM, Class 1 |
| Intended Use / | ||
| Indications for Use | Hardy Diagnostics' Viral Transport | |
| Medium (VTM) is intended for the | ||
| collection and transport of clinical | ||
| specimens for the preservation of | ||
| viral agents including, Influenza A, | ||
| Influenza B, Adenovirus, and | ||
| Echovirus from the collection site to | ||
| the testing laboratory Hardy | Copan Universal Transport | |
| Medium (UTM-RT) System is | ||
| intended for the collection and | ||
| transport of clinical specimens | ||
| containing viruses, Chlamydiae, | ||
| Mycoplasma or Ureaplasma | ||
| from the collection site to the | ||
| testing laboratory UTM RT can | ||
| New Device | ||
| Hardy Diagnostics' Viral | ||
| Transport Medium | ||
| K233534 | Predicate Device | |
| Copan Universal Transport | ||
| Medium (UTM-RT) System | ||
| K042970 | ||
| Device Similarities | ||
| Diagnostics' VTM is a culture-based media that is intended to be used in standard laboratory procedures for virus culture and diagnostic assays that utilize stable recoverable infectious viral particles. | be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture. | |
| Tube Material | Plastic Screw-Cap Tube | Same |
| pH | $7.3 \pm 0.2$ at 25°C | Same |
| Shelf-life | 365 days | Same |
| Storage Temperature | 2-25°C | Same |
| Single Use Device | Yes | Same |
| Device Differences | ||
| Media Formulation | • Hank's Balanced Salts Solution (HBSS) | |
| • Fetal Bovine Serum | ||
| • Sucrose | ||
| • Amphotericin B | ||
| • Gentamicin Sulfate | ||
| • Phenol Red | • Hank's Balanced Salts solution (HBSS) | |
| • Bovine Serum Albumin (BSA) | ||
| • Vancomycin | ||
| • Amphotericin B | ||
| • Colistin | ||
| • L-Glutamic Acid | ||
| • L-Cysteine | ||
| • HEPES Buffer | ||
| • Phenol Red | ||
| • Gelatin | ||
| • Sucrose | ||
| Supported Strains | • Adenovirus | |
| • Echovirus | ||
| • Influenza A | ||
| • Influenza B | • Adenovirus | |
| • Cytomegalovirus | ||
| • Echovirus Type 30 | ||
| • Herpes Simplex Virus Type 1 | ||
| • Herpes Simplex Virus Type 2 | ||
| • Influenza A | ||
| • Parainfluenza 3 | ||
| • Respiratory Syncytial Virus | ||
| • Varicella Zoster Virus | ||
| • Chlamydia pneumoniae | ||
| • Chlamydia trachomatis | ||
| • Mycoplasma hominis | ||
| • Mycoplasma pneumoniae | ||
| • Ureaplasma urealyticum |
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VIII. Shelf-life Stability
The shelf life of Hardy Diagnostics' Viral Transport Medium was determined to be 12 months from the date of manufacture when stored at 2-25°C. Three lots of VTM were assessed qualitatively at each time point for functionality and physical characteristics using real time ageing studies. In the real time stability study, media lots were held at 2-8°C and 20-25°C for 12 months. At each timepoint of testing, performance (virus viability), pH, appearance, and fill volume of the media were examined.
A microbial contamination check was performed to verify the stability of the incorporated antibiotics. 100uL of VTM was inoculated to blood agar and SabDex plates, and incubated at 35°C for a minimum of 48 hours to ensure that no contamination was present. No growth was observed on any of the plates tested.
Overall, all results met the study acceptance criteria and support a shelf-life stability of Hardy Diagnostics' VTM for up to 12 months or 365 days.
Viral Recovery Performance IX.
The performance of Hardy Diagnostics' Viral Transport Medium was evaluated for virus viability across various conditions, including two different incubation temperatures and multiple days. The viral recovery study was conducted by spiking a known virus concentration into pooled negative clinical matrix. The contrived viral samples were then inoculated to a minimum of three lots of Viral Transport Medium and held at 2-8°C and 20-25°C for 0, 24, and 48 hours. Aliquots of each lot were pulled at 0, 24, and 48 hours, serially diluted, and inoculated in triplicate into the susceptible host cell line. Host cells were plated at a suitable density in culture medium in microwell plates prior to testing. Virus induced cytopathic effect (CPE) was observed and the viral titer was determined by calculating the fifty-percent tissue culture infective dose (TCIDsomL) using the Reed-Muench method. Results were considered acceptable if the average viral recovery for each time point and storage condition demonstrate any percent changes within ±90% (i.e., 1 log change) from baseline (T=0).
The results are presented in Tables 1 and 2.
| Test Strain | Viral recovery
(TCID50/mL)
at T=0 hrs. | Percent changes in viral recovery
from the baseline (T= 0 hr.)
(-ve indicates reduction) | |
|-------------|----------------------------------------------|------------------------------------------------------------------------------------------------|---------|
| | | 24 hrs. | 48 hrs. |
| Influenza A | 2.12x103 | -92.24* | -59.76 |
| Influenza B | 7.23x102 | -23.86 | -3.45 |
| Echovirus | 1.40x105 | -20.55 | -25.23 |
| Adenovirus | 1.92x103 | 18.11 | -7.71 |
- Considered acceptable because subsequent timepoints, i.e., 48 h time point showed