(344 days)
Not Found
No
The device description and performance studies focus on the collection and transport medium itself, with no mention of any analytical or interpretive functions that would typically involve AI/ML. The performance studies evaluate the recovery of viruses and bacteria in the medium, not the performance of an algorithm.
No
The device is intended for the collection and transport of clinical specimens for diagnostic purposes, not for treating a disease or condition.
No
The device is a viral transport system designed for the collection and transport of clinical specimens, not for analysis or diagnosis. The diagnosis happens in a separate laboratory setting.
No
The device description clearly states it includes physical components such as a plastic screw-cap tube, transport medium, and potentially a flocked swab, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "collection and transport of clinical specimens containing respiratory viruses, Chlamydiae, or Mycoplasma hominis from the collection site to the testing laboratory." It also mentions that the system is intended to be used with "standard laboratory examination, culture or with other assays." This clearly indicates that the device is used to prepare a specimen for subsequent diagnostic testing.
- Device Description: The description details a "transport medium" and a "kit format with a flocked swab," which are components used in the process of collecting and preserving a biological specimen for diagnostic analysis.
- Performance Studies: The performance studies focus on the "Culture-Based Recovery Studies" of various viral and bacterial test strains. This demonstrates that the device's performance is evaluated based on its ability to maintain the viability of pathogens for diagnostic purposes.
- Predicate Device: The mention of a predicate device (K042970; Copan Universal Transport Medium (UTM-RT) System) which is also a viral transport medium, further supports the classification of this device as an IVD. Predicate devices are typically other legally marketed devices with similar intended uses and technological characteristics, and viral transport media are commonly classified as IVDs.
In summary, the iClean Viral Transport System (VTM-RT) is designed to collect and transport clinical specimens for subsequent diagnostic testing in a laboratory setting, which is the core function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
iClean Viral Transport System (VTM-RT) is intended for the collection and transport of clinical specimens containing respiratory viruses, Chlamydiae, or Mycoplasma hominis from the collection site to the testing laboratory. The collection system is a culture based media that is intended to be used with standard laboratory examination, culture or with other assays that utilize stable recoverable infectious viral particles or bacteria.
Product codes (comma separated list FDA assigned to the subject device)
JSM
Device Description
iClean Viral Transport System (VTM-RT) is intended for the collection and transport of clinical specimens containing respiratory viruses, Chlamydiae, or Mycoplasma hominis from the collection site to the testing laboratory. iClean Viral Transport System (VTM-RT) includes a plastic screw-cap tube with conical bottom containing 3mL transport medium. iClean Viral Transport System (VTM-RT) tubes can be supplied alone, or in a kit format with a flocked swab in a sterile peel pouch (or 100 kits packed together in a color box).
iClean Viral Transport System (VTM-RT) medium is stable at room temperature and consists of: Hanks balanced salt solution (HBSS), Bovine Serum Albumin (BSA), Gentamicin sulfate, Amphotericin B, Colistin, L-glutamic acid, HEPES buffer and Phenol red. The neutral environment constructed by Hank's buffer helps to increase the stability of the virus. Bovine Serum Albumin (BSA) acts as a protein stabilizer, forming a protective film on the protein shell of the virus, making it less likely to break down and ensuring the integrity of the virus. Gentamicin sulfate, amphotericin B, and colistin inhibit growth of bacteria or yeast. L-glutamic acid serves as an auxiliary energy source to keep cell and virus stability. HEPES buffer provides additional help to maintain a stable pH value environment thus increases the stability of virus. Phenol red is a pH indicator which serves as a visual quality control mechanism. As this medium does not contain cysteine, gelatin, or sucrose, it cannot be used to freeze virus samples for long-term preservation. The medium is isotonic and non-toxic to mammalian host cells.
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
Health Care Professionals (HCPs), testing laboratory
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Shelf Life Study:
- Study Type: Real-time aging performance test.
- Sample Size: Three lots of iClean VTM for appearance and pH stability. For antibiotic stability, inoculated media was tested.
- Key Results:
- Appearance Inspection: All results acceptable, visually clear (no turbidity, cloudy, or precipitation), maintains pink color, media volume at 3.0mL across all time points (T=0, 1, 3, 6, 9, 12 months).
- pH Stability: pH was within 7.4 ± 0.4 for all tubes at all time points across the three lots.
- Antibiotic Stability: No growth of Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8099, and Candida albicans ATCC 10231 at 24 and 48 hours for inoculated media, supporting antibiotic efficacy.
- Sterilization: The product is not sterile; tubes and packaging are gamma-radiated. Media is filtered and aseptically filled. Quality control showed no growth of bacteria and fungi.
- All results collectively support a 12-month shelf-life.
Performance Testing - Recovery Studies:
- Study Type: Culture-Based Recovery Studies for viral and bacterial test strains.
- Sample Size: Nine lots of media (categorized as "New," "Mid," and "Old").
- Key Results:
- Viral Recovery Studies (Fluorescent Foci Count method):
- Test Strains: Influenza A, Parainfluenza 3, Respiratory Syncytial Virus, Chlamydia pneumoniae, C. trachomatis.
- Storage Conditions: 4°C and 25°C for 0, 24, and 48 hours.
- Results (4°C storage): Percent decline in foci count from 0-48 hours varied by strain and lot, generally showing recovery. For example, Influenza A showed declines ranging from 27% to 92%, Parainfluenza 3 from -5% to 58%, Respiratory Syncytial Virus from 9% to 49%, Chlamydia pneumoniae from 33% to 90%, and Chlamydia trachomatis from -6% to 86%.
- Results (25°C storage): Percent decline in foci count from 0-48 hours was generally higher at 25°C. For example, Influenza A showed declines ranging from 79% to 91%, Parainfluenza 3 from 79% to 93%, Respiratory Syncytial Virus from 79% to 95%, Chlamydia pneumoniae from -194% (one outlier) to 94%, and Chlamydia trachomatis from 35% to 96%.
- Bacterial Recovery Studies (Roll-Plate method and Swab Elution Method):
- Test Strain: Mycoplasma hominis (ATCC VR-14027).
- Storage Conditions: Refrigerated (2-8°C) and room temperature (22-25°C) for 0, 24, and 48 hours.
- Roll-Plate Method (Refrigerated): Average recovery in CFU/roll-plate at 48 hours ranged from 95 to 181, meeting the acceptance criteria of ≥ 10 CFU recovery.
- Roll-Plate Method (Room Temperature): Average recovery in CFU/roll-plate at 48 hours ranged from 72 to 134, meeting the acceptance criteria of ≥ 10 CFU recovery.
- Swab Elution Method (Refrigerated): Change in log10 CFU (0 to 48 hours) ranged from -0.5 to -1.0, meeting the acceptance criteria of no more than a 3 log10 change.
- Swab Elution Method (Room Temperature): Change in log10 CFU (0 to 48 hours) ranged from -0.7 to -1.3, meeting the acceptance criteria of no more than a 3 log10 change (excluding any outliers in calculation that might exceed this).
- Viral Recovery Studies (Fluorescent Foci Count method):
Conclusion: The iClean VTM demonstrated the recovery of tested viruses, Chlamydia pneumoniae, C. trachomatis and Mycoplasma hominis in all replicates at tested incubation times and storage conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Shelf Life: 12 months
- Appearance: Visual confirmation of clear, pink media at all time points.
- pH Stability: 7.4 ± 0.4
- Antibiotic Stability: No growth of S. aureus, E. coli, C. albicans at 24 and 48 hours for inoculated media.
- Viral and Chlamydia Recovery (Fluorescent Foci Count): Percent decline in foci counts from 0 to 48 hours, varying by strain, lot, and temperature.
- Bacterial Recovery (Roll-Plate Method): ≥ 10 CFU recovery at specified maintenance times.
- Bacterial Recovery (Swab Elution Method): ≤ 3 log10 change in CFU count between 0 and 48 hours.
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.
Copan Universal Transport Medium (UTM-RT) System (K042970)
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).
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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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 18, 2022
Huachenyang (Shenzhen) Technology Co. Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K212856
Trade/Device Name: iClean Viral Transport System (VTM-RT kit) Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: Class I, reserved Product Code: JSM Dated: September 7, 2021 Received: September 8, 2021
Dear Prithul Bom:
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 (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 located 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
for Uwe Scherf, M.Sc., Ph.D. Director 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) K212856
Device Name iClean Viral Transport System (VTM-RT kit)
Indications for Use (Describe)
iClean Viral Transport System (VTM-RT) is intended for the collection and transport of clinical specimens containing respiratory viruses, Chlamydiae, or Mycoplasma hominis from the to the testing laboratory. The collection system is a culture based media that is intended to be used with standard laboratory examination, culture or with other assays that utilize stable recoverable infectious viral particles or bacteria.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K212856
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the iClean Viral Transport System (VTM- RT).
| Submitted by | Huachenyang (Shenzen) Technology Co., Ltd. |
|---|---|
| Contact Person | Gong Zanbin, Production & Regulation Manager |
| Huachenyang (Shenzen) Technology Co., Ltd. | |
| F8/Bldg. 4, Hengchangrong High Industrial Park, No.128 East | |
| Road, Shangnan, Shajing Street, Baoan, Shenzhen, China Email: | |
| info@chenyanglobal.com; c06@chenyanglobal.com Telephone | |
| Number: + 86-755-27393226 | |
| Fax Number: + 86-755-27381080 | |
| Proprietary Name | iClean Viral Transport System (VTM-RT) |
| Common Name | Transport culture medium |
| Review Panel | Microbiology |
| Classification Name and | |
| Reference | 21 CFR 886.2390, Culture Media, Non-Propagating Transport |
| Device Product Code and | |
| Panel Code | JSM; Transport culture medium |
| Predicate Device | Copan Universal Transport Medium (UTM-RT) System (K042970) |
1. Intended Use and Indications for Use
iClean Viral Transport System (VTM-RT) is intended for the collection and transport of clinical specimens containing respiratory viruses, Chlamydiae, or Mycoplasma hominis from the collection site to the testing laboratory. The collection system is a culture based media that is intended to be used with standard laboratory examination, culture or with other assays that utilize stable recoverable infectious viral particles or bacteria.
2. Device Description
iClean Viral Transport System (VTM-RT) is intended for the collection and transport of clinical specimens containing respiratory viruses, Chlamydiae, or Mycoplasma hominis from the collection site to the testing laboratory. iClean Viral Transport System (VTM-RT) includes a plastic screw-cap tube with conical bottom containing 3mL transport medium. iClean Viral Transport System (VTM-RT) tubes can be supplied alone, or in a kit format with a flocked swab in a sterile peel pouch (or 100 kits packed together in a color box).
iClean Viral Transport System (VTM-RT) medium is stable at room temperature and consists of: Hanks balanced salt solution (HBSS), Bovine Serum Albumin (BSA), Gentamicin sulfate, Amphotericin B, Colistin, L-glutamic acid, HEPES buffer and Phenol red. The neutral environment constructed by Hank's buffer helps to increase the stability of the virus. Bovine Serum Albumin (BSA) acts as a protein stabilizer, forming a protective film on the protein shell of the virus, making it less likely to break down and ensuring the integrity of the virus. Gentamicin sulfate, amphotericin B, and colistin inhibit growth of bacteria or yeast. L-glutamic acid serves as an auxiliary energy source to keep cell and virus stability. HEPES buffer provides additional help to maintain a stable pH value environment thus increases the
4
stability of virus. Phenol red is a pH indicator which serves as a visual quality control mechanism. As this medium does not contain cysteine, gelatin, or sucrose, it cannot be used to freeze virus samples for long-term preservation. The medium is isotonic and non-toxic to mammalian host cells.
3. Device Specification
iClean transport medium tubes can be supplied alone including a screw-cap tube containing 3mL of transport medium or in a kit format with one of the following collection swab configurations in a sterile peel pouch (or 100 kits packed together in a color box):
| Catalog No. | Description | Pack |
|---|---|---|
| CY-B-F005-20 | 3mL transport medium vial with iClean® nasopharyngeal | |
| flocked Swab | Single pack or | |
| 10*10 kits | ||
| CY-B-F005-20 | 3mL transport medium vial with iClean® buccal flocked | |
| Swab | Single pack or | |
| 10*10 kits | ||
| CY-B-F005-20 | 3mL transport medium vial with iClean® oropharyngeal | |
| flocked Swab | Single pack or | |
| 10*10 kits | ||
| CY-B-F005-20 | 3mL transport medium vial with iClean® nasopharyngeal | |
| flocked Swab and oropharyngeal flocked Swab | Single pack or | |
| 10*10 kits |
The swabs in this kit are listed according to 21CFR Part 807 under the proprietary name of "Antiseptic Swab Applicator, Specimen Collection Flocked / Polyester / Foam / Cotton / Rayon Swab, Nasal / Oral / Throat / Cervical", registered under Huachenyang (Shenzhen) Technology Company Ltd (Registered establishment number: 3011649813). These swabs are not purchased in bulk, but are purchased in finished form, i.e., they are packaged, labeled, etc., consistent with their device listing criteria and status. Also, there were no recorded adverse events and/or quality problems of the swabs so far.
Media Formulation:
- Hanks balanced salt solution (HBSS) ●
- Bovine Serum Albumin (BSA) ●
- Gentamicin sulfate .
- . Amphotericin B
- Colistin
- L-glutamic acid .
- HEPES buffer ●
- Phenol red ●
iClean Viral Transport System (VTM-RT) should be stored in a clean, dry, ventilated environment at 2 - 25℃. The shelf-life of iClean Viral Transport System (VTM-RT) is 12 months after the manufacture date.
4. Principle of Operation
The iClean VTM-RT functions as a general transport medium kit for collecting and
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transporting clinical specimens. This transport medium is used to safely collect and transport viruses, Chlamydiae, or Mycoplasma hominis from collection sites to the testing laboratories. It is intended for use by Health Care Professionals (HCPs), the transport system allows for the collection of the specimen via the sterile swab, maintenance through a buffered media, prevention of microbial growth via antimicrobial agents, as well as a pH indicator. The media has been validated with culture recovery of virus. The sterile swab provided in the kit is packaged in peeled pouch for specimen collection. The cap from the vial is intended to be removed aseptically, and the sample collection swab is inserted into the vial containing the iClean VTM-RT Medium. After the collected sample is placed into the transport media, it is transported to the laboratory.
Proper specimen collection plays a critical role for successful isolation and identification of infectious organisms. Once the sample is collected it should be placed immediately into the media inside the tube and transported to the laboratory. Although the media can maintain even fragile organisms for long periods of time at room temperature, it is recommended that specimens be refrigerated at 2 - 8°C while in transit.
5. Substantial Equivalence
The iClean Viral Transport System (VTM-RT) is compared with the predicate device, Copan Universal Transport Medium (UTM-RT) System, in intended use, medium formulation, container, product configuration, shelf life, packaging and volume. The safety and effectiveness of the iClean Viral Transport System (VTM-RT) with the expanded claims is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification. Below is a summary of comparison between iClean VTM-RT and predicate Copan Universal Transport Medium (UTM-RT) System:
| | Subject Device
(K212856) | Predicate Device
(K042970) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | iClean Viral Transport System (VTM-
RT kit) | Copan Universal Transport Medium
(UTM-RT) System |
| Device Product Code and
Classification | JSM, Class I | JSM, Class I |
| General Device Characteristic Similarities | | |
| Intended Use / Indications
For Use | iClean Viral Transport System
(VTM- RT) is intended for the
collection and transport of clinical
specimens containing respiratory
viruses, Chlamydiae, or
Mycoplasma hominis from the
collection site to the testing
laboratory. The collection system is
a culture based media that is
intended to be used with standard
laboratory examination, culture or
with other assays that utilize stable
recoverable infectious viral particles
or bacteria. | 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 be
processed using standard clinical
laboratory operating procedures for
viral, chlamydial, mycoplasma and
ureaplasma culture. |
| Storage Temperature | $20^{\circ}$ -25°C | Same |
| Tube Material | Plastic Screw-Cap Tube | Same |
| Single Use Device | Yes | Same |
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| pH | $7.4 \pm 0.4$ | Same |
|---|---|---|
| Shelf-life | 12 months | Same |
| Validation | Culture | Same |
| General Device Characteristic Differences | ||
| Media Formulation | • Hanks balanced salt solution (HBSS) | |
| • Bovine Serum Albumin (BSA) | ||
| • Gentamicin sulfate | ||
| • Amphotericin B | ||
| • Colistin | ||
| • L-Glutamic acid | ||
| • HEPES buffer | ||
| • 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 | |
| • 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 | • 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 |
As seen with the comparison above, the differences between iClean Viral Transport System (VTM-RT) and the predicate's specification, safety and performance are comparable.
6. Shelf Life
The shelf life for the iClean VTM-RT was determined to be 12 months from the date of manufacture when stored in a clean, dry, ventilated environment at 20-25℃. The shelf life of the iClean VTM-RT was established using real-time aging performance test at time points T = 0, 1, 3, 6, 9 and 12 months. At each time point, appearance, volume, pH, antibiotic stability, and recovery study were assessed.
a. Appearance Inspection:
To evaluate appearance stability, three lots of iClean VTM were physically examined for real-time aging at timepoints T = 0, 1, 3, 6, 9, and 12 months. The media was stored in a clean, dry, ventilated environment at 20 - 25℃. At each time point, appearance of the product was inspected visually to be clear (i. e. no turbidity, no cloudy nor precipitation) and maintains a pink color (i.e., no color change from pink to yellow). Media volume was assessed to ensure each tube was filled to 3.0mL. All results were acceptable and support the claim that the VTM-RT is physically stable for 12 months.
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b. pH Stability
The pH of the media was used as one of the indicators to support product stability. The media was tested at time points T = 0, 1, 3, 6, 9 and 12 months after the manufacturing date. Three lots of VTM-RT media were stored in a clean, dry, ventilated environment under the recommended temperature conditions (20 - 25℃) and at the specified time intervals, 15 tubes from each of the three lots were removed from storage. The media inside each of the vials was evaluated using a calibrated pH meter. For all the tubes at each time point and each of the three lots, the pH was within the targe of 7.4 ± 0.4.
c. Antibiotic Stability:
iClean VTM-RT contains gentamicin sulfate, amphotericin B, and colistin to inhibit growth of bacteria or yeast. Stability of these antibiotics was evaluated through inoculating 5.0 x 10 - 4.5 x 10° CFU/mL of Staphylococcus aureus ATCC 6538, Escherichia coli ATCC 8099, and Candida albicans ATCC 10231 into iClean VTM media followed by appropriate storage and incubation. The inoculated media was tested immediately or stored in VTM for 24 hrs. Spiked media was transferred by pipetting 0.5 mL onto nutrient agar plates for S. aureus and E. coli and Sabouraud media for C. albicans. All plates evaluated at time T = 0 had 9.0 x 104 cfu/mL growth or greater while plates evaluated at 24 and 48 hrs. all had no growth.
d. Sterilization:
The iClean VTM kit is not claimed to be sterile nor is it intended to be sterilized by the end user. To decrease the chances of contamination the media uses specific manufacturing steps including sterilization of tubes and packaging by gamma radiation set at a dose of 5.3 Kilo Gray (KGy), in accordance with ISO 11137- 2:2015. The media is filtered using a 0.22 um sterile fiber membrane and then is aseptically filled into the pre-sterilized tubes. The aseptic status of the filtered iClean VTM-RT was then validated by a quality control process which evaluates the absence of growth of bacteria and fungi by spreading 0.1 mL of the filtered VTM- RT medium on nutrient agar and Sabouraud media plates and incubated at 35℃ ± 2℃ for 24 - 48 hours. No growth on any of the plates tested was observed.
The results collectively for appearance, volume, pH, antibiotic stability support the 12-month stability claim for the iClean VTM-RT.
7. Performance Testing - Recovery Studies
Performance of the iClean VTM was evaluated by Culture-Based Recovery Studies for viral and bacterial test strains. For Viral Recovery Studies, Fluorescent Foci Count method was utilized to evaluate the recovery of Influenza A (ATCC VR-544), Parainfluenza 3 (ATCC VR- 93) and Respiratory Syncytial Virus (ATCC VR-1401). This method was also utilized to evaluate the recovery of Chlamydia pneumoniae (ATCC VR-53592) and C. trachomatis (ATCC VR-880). For Bacterial Recovery Studies, Roll-Plate and Swab Elution Methods were utilized to evaluate the recovery of Mycoplasma hominis (ATCC VR-14027). Performance testing included nine lots of media. Each performance study summarized below used media lots that represents "New" for newly manufactured media, "Mid" for middle aged media (~5 months old) and "Old" for older media about to expire or recently expired media.
Viral Recovery Studies:
Virus stocks were diluted in pooled negative clinical matrix and each chosen dilution was inoculated
8
into swab and placed into iClean VTM to store at 4℃ and 25℃ for 0, 24 and 48 hours respectively. For tissue culture, Hep-2 cells (ATCC CCL-23) or McCoy cells (ATCC CRL-1696) were grown to 95% confluency. When tissue culture plates were ready, 200 µl of each test samples were used to infect the monolayers and incubated. For detection, specific immunofluorescent antibody staining was used. The number of infectious particles were counted as Fluorescent Foci and calculated for each storage temperature and time points.
McCoy cell cultures were used for the recovery of Chlamydia (ATCC VR-53592) and C. trachomatis (ATCC VR-880). The results are presented in the Table 1 and Table 2 below. Any reduction in the foci count in the timepoints (0 to 48 hr.) was shown in percent decline.
| Test Strain | Lot No. | Lot Age | Average Recovery in Foci count/mL | Decline in 0 - 48 hrs. | ||
|---|---|---|---|---|---|---|
| Influenza A | 2021010105 | $7.1×10^3$ | $6×10^3$ | $4.9×10^3$ | 31% | |
| 2021010108 | Old | $1×10^4$ | $6.5×10^3$ | $5.7×10^3$ | 43% | |
| 2021010205 | $1.1×10^4$ | $8.8×10^3$ | $7×10^3$ | 36% | ||
| 2021060105 | $1.1×10^4$ | $9×10^3$ | $7.6×10^3$ | 31% | ||
| 2021060108 | Mid | $1.2×10^4$ | $8.6×10^3$ | $6.5×10^3$ | 46% | |
| 2021060201 | $8.6×10^3$ | $7.4×10^3$ | $4.8×10^3$ | 44% | ||
| 2021120101 | $9.2×10^3$ | $8.6×10^3$ | $6.7×10^3$ | 27% | ||
| 2021120102 | New | $1.2×10^4$ | $6.4×10^3$ | $8.8×10^3$ | 27% | |
| 2021120103 | $9.1×10^4$ | $8.5×10^3$ | $7.1×10^3$ | 92% | ||
| Parainfluenza 3 | 2021010105 | $8.2×10^3$ | $7.9×10^3$ | $8.6×10^3$ | -5% | |
| 2021010108 | Old | $7.9×10^3$ | $7×10^3$ | $7.1×10^3$ | 10% | |
| 2021010205 | $1.2×10^4$ | $7×10^3$ | $5×10^3$ | 58% | ||
| 2021060105 | $1×10^4$ | $8.4×10^3$ | $7.7×10^3$ | 23% | ||
| 2021060108 | Mid | $1.1×10^4$ | $8.2×10^3$ | $4.9×10^3$ | 55% | |
| 2021060201 | $1.4×10^4$ | $7.2×10^3$ | $6.2×10^3$ | 56% | ||
| 2021120101 | $1×10^4$ | $9.5×10^3$ | $5.5×10^3$ | 45% | ||
| 2021120102 | New | $1.1×10^4$ | $7.2×10^3$ | $8.4×10^3$ | 24% | |
| 2021120103 | $1.3×10^4$ | $1×10^4$ | $5.8×10^3$ | 55% | ||
| Respiratory | ||||||
| Syncytial Virus | 2021010105 | $7.3×10^3$ | $8.5×10^3$ | $6.3×10^3$ | 14% | |
| 2021010108 | Old | $8.6×10^3$ | $8.4×10^3$ | $7.5×10^3$ | 13% | |
| 2021010205 | $1.2×10^4$ | $9.3×10^3$ | $7.8×10^3$ | 35% | ||
| 2021060105 | $1.1×10^4$ | $8.1×10^3$ | $6.3×10^3$ | 43% | ||
| 2021060108 | Mid | $1.1×10^4$ | $8.3×10^3$ | $7.4×10^3$ | 33% | |
| 2021060201 | $1.2×10^4$ | $8.9×10^3$ | $6.1×10^3$ | 49% | ||
| 2021120101 | $8.6×10^3$ | $1.1×10^4$ | $7.8×10^3$ | 9% | ||
| 2021120102 | New | $8.5×10^3$ | $1×10^4$ | $5.3×10^3$ | 38% | |
| 2021120103 | $8×10^3$ | $7.6×10^3$ | $6.2×10^3$ | 23% | ||
| Chlamydia | ||||||
| pneumoniae | 2021010105 | $1.1\times10^6$ | $3.2\times10^5$ | $2.4\times10^5$ | 78% | |
| 2021010108 | Old | $2.8\times10^6$ | $1.0\times10^6$ | $5.3\times10^5$ | 81% | |
| 2021010205 | $2.6\times10^6$ | $1.5\times10^6$ | $3.1\times10^5$ | 88% | ||
| 2021060105 | Mid | $1.9\times10^6$ | $1.4\times10^6$ | $1.9\times10^5$ | 90% | |
| 2021060108 | $2.4\times10^6$ | $1.5\times10^6$ | $5.8\times10^5$ | 76% | ||
| 2021060201 | $1.8\times10^6$ | $5.1\times10^5$ | $5.7\times10^5$ | 68% | ||
| 2021120101 | $1.5\times10^6$ | $8.4\times10^5$ | $3.3\times10^5$ | 78% | ||
| 2021120102 | New | $1.9\times10^6$ | $1.4\times10^6$ | $3.3\times10^5$ | 83% | |
| 2021120103 | $1.2\times10^6$ | $1.0\times10^6$ | $8.1\times10^5$ | 33% | ||
| Chlamydia | ||||||
| trachomatis | 2021010105 | $1.6\times10^6$ | $4.6\times10^5$ | $5.0\times10^5$ | 69% | |
| 2021010108 | Old | $8.0\times10^5$ | $4.0\times10^5$ | $8.5\times10^5$ | -6% | |
| 2021010205 | $1.5\times10^6$ | $6.5\times10^5$ | $2.3\times10^5$ | 85% | ||
| 2021060105 | $2.3\times10^6$ | $5.3\times10^5$ | $3.2\times10^5$ | 86% | ||
| 2021060108 | Mid | $8.3\times10^5$ | $4.3\times10^5$ | $4.9\times10^5$ | 41% | |
| 2021060201 | $2.4\times10^6$ | $1.4\times10^6$ | $5.0\times10^5$ | 79% | ||
| 2021120101 | $1.2\times10^6$ | $9.2\times10^5$ | $6.6\times10^5$ | 45% | ||
| 2021120102 | New | $2.7\times10^6$ | $7.7\times10^5$ | $4.5\times10^5$ | 83% | |
| 2021120103 | $1.6\times10^6$ | $1.1\times10^6$ | $7.3\times10^5$ | 54% |
Table 1. Recovery of viruses and Chlamydiae at 4℃ storage.
9
Table 2. Recovery of viruses and Chlamydiae at 25°C storage.
| Test Strain | Lot No. | Lot Age | Average Recovery in Foci count/mL | | | Decline in
0 - 48 hrs. |
|-----------------|------------|---------|-----------------------------------|-----------------|-----------------|---------------------------|
| | | | 0 hr. | 24 hrs. | 48 hrs. | |
| Influenza A | 2021010105 | | $8.1\times10^3$ | $7.3\times10^3$ | $7\times10^2$ | 91% |
| | 2021010108 | Old | $9.3\times10^3$ | $7.2\times10^3$ | $1.1\times10^3$ | 88% |
| | 2021010205 | | $1.1\times10^4$ | $7.2\times10^3$ | $1.7\times10^3$ | 85% |
| | 2021060105 | | $1.2\times10^4$ | $8.2\times10^3$ | $1.3\times10^3$ | 89% |
| | 2021060108 | Mid | $1\times10^4$ | $8\times10^3$ | $2.1\times10^3$ | 79% |
| | 2021060201 | | $9.4\times10^3$ | $5.6\times10^3$ | $1.9\times10^3$ | 80% |
| | 2021120101 | | $9.5\times10^3$ | $6.9\times10^3$ | $1.5\times10^3$ | 84% |
| | 2021120102 | New | $1.1\times10^4$ | $6.7\times10^3$ | $2.2\times10^3$ | 80% |
| | 2021120103 | | $1.2\times10^4$ | $7.7\times10^3$ | $1.4\times10^3$ | 88% |
| Parainfluenza 3 | 2021010105 | | $1.3\times10^4$ | $6.1\times10^3$ | $1\times10^3$ | 92% |
| | 2021010108 | Old | $1.3\times10^4$ | $7.9\times10^3$ | $8.8\times10^2$ | 93% |
| | 2021010205 | | $1.1\times10^4$ | $8.7\times10^3$ | $9.1\times10^2$ | 92% |
| | 2021060105 | | $9.3\times10^3$ | $5.9\times10^3$ | $1.9\times10^3$ | 80% |
| | 2021060108 | Mid | $9.2\times10^3$ | $8.1\times10^3$ | $8.4\times10^2$ | 91% |
| | 2021060201 | | $9.5\times10^3$ | $7.4\times10^3$ | $7\times10^2$ | 93% |
| | 2021120101 | | $1\times10^4$ | $9.1\times10^3$ | $2.1\times10^3$ | 79% |
| | 2021120102 | New | $1.2\times10^4$ | $8.6\times10^3$ | $1.7\times10^3$ | 86% |
| | 2021120103 | | $1.1\times10^4$ | $7.3\times10^3$ | $1.6\times10^3$ | 85% |
10
| Respiratory
| Syncytial Virus | ||||||
|---|---|---|---|---|---|---|
| 2021010105 | $9.2\times10^3$ | $7.8\times10^3$ | $1.9\times10^3$ | 79% | ||
| 2021010108 | Old | $8\times10^3$ | $9.4\times10^3$ | $1.1\times10^3$ | 86% | |
| 2021010205 | $1.1\times10^4$ | $5.6\times10^3$ | $9.5\times10^2$ | 91% | ||
| 2021060105 | $1.3\times10^4$ | $6\times10^3$ | $6.8\times10^2$ | 95% | ||
| 2021060108 | Mid | $8.7\times10^3$ | $6.4\times10^3$ | $5.9\times10^2$ | 93% | |
| 2021060201 | $1.2\times10^4$ | $8.7\times10^3$ | $1.3\times10^3$ | 89% | ||
| 2021120101 | $8.4\times10^3$ | $5.9\times10^3$ | $6.3\times10^2$ | 93% | ||
| 2021120102 | New | $1\times10^4$ | $7.8\times10^3$ | $1.1\times10^3$ | 89% | |
| 2021120103 | $9.6\times10^3$ | $6.5\times10^3$ | $1.3\times10^3$ | 86% | ||
| Chlamydia | ||||||
| pneumoniae | ||||||
| 2021010105 | $1.5\times10^6$ | $6.6\times10^5$ | $1.9\times10^5$ | 87% | ||
| 2021010108 | Old | $8.5\times10^5$ | $4.2\times10^5$ | $2.5\times10^6$ | -194% | |
| 2021010205 | $1.4\times10^6$ | $1.1\times10^6$ | $2.3\times10^5$ | 84% | ||
| 2021060105 | $1.8\times10^6$ | $8.3\times10^5$ | $1.8\times10^5$ | 90% | ||
| 2021060108 | Mid | $2.7\times10^6$ | $9.1\times10^5$ | $1.9\times10^5$ | 93% | |
| 2021060201 | $1.4\times10^6$ | $1.0\times10^6$ | $2.2\times10^5$ | 84% | ||
| 2021120101 | $1.7\times10^6$ | $3.0\times10^5$ | $2.4\times10^5$ | 86% | ||
| 2021120102 | New | $1.3\times10^6$ | $9.1\times10^5$ | $7.9\times10^4$ | 94% | |
| 2021120103 | $1.7\times10^6$ | $8.5\times10^5$ | $2.1\times10^5$ | 88% | ||
| Chlamydia | ||||||
| trachomatis | ||||||
| 2021010105 | $1.2\times10^6$ | $6.7\times10^5$ | $1.7\times10^5$ | 86% | ||
| 2021010108 | Old | $2.6\times10^6$ | $4.8\times10^5$ | $1.7\times10^5$ | 93% | |
| 2021010205 | $2.2\times10^6$ | $4.3\times10^5$ | $9.6\times10^4$ | 96% | ||
| 2021060105 | $1.5\times10^6$ | $4.7\times10^5$ | $2.4\times10^5$ | 84% | ||
| 2021060108 | Mid | $9.2\times10^5$ | $3.4\times10^5$ | $1.5\times10^5$ | 84% | |
| 2021060201 | $1.3\times10^6$ | $7.7\times10^6$ | $7.5\times10^4$ | 42% | ||
| 2021120101 | $1.1\times10^6$ | $1.0\times10^6$ | $7.2\times10^4$ | 35% | ||
| 2021120102 | New | $2.4\times10^6$ | $9.0\times10^5$ | $2.0\times10^5$ | 92% | |
| 2021120103 | $1.7\times10^6$ | $1.0\times10^6$ | $1.8\times10^5$ | 89% |
Bacterial Recovery Studies:
Performance of iClean VTM for bacterial recovery was determined using roll plate swab elution methods. Both the roll plate and swab elution studies follow the FDA recognized sections of CLSI M40-A2:2014 Quality Control of Microbiological Transport Systems: Approved Standard – Second Edition.
Roll-plate method:
For the roll-plate method, Mycoplasma hominis suspensions were prepared to approximately 0.5 McFarland standard (1.5 × 10° CFU/mL) in 0.85% physiological saline followed by 10- fold serial dilutions in pooled negative matrix. Swabs in triplicate were spiked with 100 uL of each dilution and placed in the iClean VTM and maintained under refrigerated or at room temperature. After 0, 24 and 48 hours, the swabs were removed and rolled directly onto agar plates which were incubated to grow colonies. Average CFU/roll-plate calculated for each timepoints were presented in Table 4. According to CLSI M40 A2 guidelines, the inoculum dilutions yielding time-zero plates with closely approaching 300 CFU was used to complete the viability studies. The acceptance criteria were set to a recovery of ≥ 10 CFU following the specified maintenance time at the iClean VTM.
11
| Test Strain | Lot No. | Lot Age | Average Recovery in CFU/roll-plate | 0 hr. | 24 hrs. | 48 hrs. |
|---|---|---|---|---|---|---|
| Mycoplasma hominis | ||||||
| (ATCC VR-14027) | 2021010105 | Old | 275 | 233 | 150 | |
| 2021010108 | 277 | 252 | 165 | |||
| 2021010205 | 264 | 220 | 118 | |||
| 2021060105 | Mid | 267 | 248 | 139 | ||
| 2021060108 | 283 | 240 | 158 | |||
| 2021060201 | 279 | 250 | 95 | |||
| 2021120101 | New | 252 | 234 | 100 | ||
| 2021120102 | 292 | 289 | 181 | |||
| 2021120103 | 248 | 212 | 111 |
| Table 3. Roll-Plate Method of recovery for storage at refrigerated conditions (2-8℃). |
|---|
Table 4. Roll-Plate Method of recovery for storage at room temperature (22-25°C).
| Test Strain | Lot No. | Lot Age | Average Recovery in CFU/Roll-plate | ||
|---|---|---|---|---|---|
| 0 hr. | 24 hrs. | 48 hrs. | |||
| Mycoplasma hominis | |||||
| (ATCC VR-14027) | 2021010105 | 267 | 283 | 107 | |
| 2021010108 | Old | 323 | 227 | 94 | |
| 2021010205 | 310 | 282 | 112 | ||
| Mycoplasma hominis | |||||
| (ATCC VR-14027) | 2021060105 | Mid | 261 | 207 | 92 |
| 2021060108 | 276 | 246 | 130 | ||
| 2021060201 | 276 | 215 | 108 | ||
| Mycoplasma hominis | |||||
| (ATCC VR-14027) | 2021120101 | New | 320 | 251 | 72 |
| 2021120102 | 297 | 278 | 82 | ||
| 2021120103 | 306 | 247 | 134 |
Swab Elution Method:
For the swab elution method, the Mycoplasma hominis inocula were prepared in a manner similar to that for the roll-plate method. The initial bacterial suspensions were diluted by 10-4 and dispensed 100 uL onto swabs in triplicate. The swabs were then placed in the iClean VTM and maintained under refrigerated or at room temperature for the specified timepoints. After 0, 24, and 48 hours the swabs were removed, and 10-fold serial dilutions were prepared. From each of the dilution, 50 µL was dispensed onto the agar plate and incubated to allow the growth of colonies. The results calculated in average CFU/mL for the specified time points are presented in Table 5 and 6. According to CLSI document M40-A2, the acceptance criteria for viability in the swab elution method was considered to be no more than a 3 log10 change in CFU count between the zero-time and the 48 hours - time points.
Table 5. Swab Elution Method of recovery for storage at refrigerated conditions (2-8°C).
| Test Strain | Lot No. | Lot Age | Average Recovery in CFU/mL | Change in log10 (0 to 48 hrs.) | ||
|---|---|---|---|---|---|---|
| 0 hr. | 24 hrs. | 48 hrs. | ||||
| 2021010105 | $2.1\times10^6$ | $5.1\times10^5$ | $2.1\times10^5$ | -1.0 | ||
| 2021010108 | Old | $1.3\times10^6$ | $7.2\times10^5$ | $3.3\times10^5$ | -0.6 | |
| 2021010205 | $1.4\times10^6$ | $3.4\times10^5$ | $1.4\times10^5$ | -1.0 | ||
| Mycoplasma hominis | 2021060105 | $1.5\times10^6$ | $7.2\times10^5$ | $2.5\times10^5$ | -0.8 | |
| 2021060108 | $2.3\times10^6$ | $4.1\times10^5$ | $2.2\times10^5$ | -1.0 |
12
| (ATCC VR-14027) | 2021060201 | Mid | $1.9\times10^6$ | $5.8\times10^5$ | $2.6\times10^5$ | -0.9 |
|---|---|---|---|---|---|---|
| 2021120101 | $8.9\times10^5$ | $4.9\times10^5$ | $1.8\times10^5$ | -0.7 | ||
| 2021120102 | New | $1.1\times10^6$ | $8.7\times10^5$ | $2.9\times10^5$ | -0.6 | |
| 2021120103 | $1.9\times10^6$ | $1.0\times10^6$ | $6.4\times10^5$ | -0.5 |
Table 6. Swab Elution Method of recovery for storage at room temperature (22-25°C).
| Test Strain | Lot No. | Lot
Age | Average Recovery in
CFU/mL | | | Change in log10
(0 to 48 hrs.) |
|---------------------------------------|------------|------------|-------------------------------|---------|---------|-----------------------------------|
| | | | 0 hr. | 24 hrs. | 48 hrs. | |
| Mycoplasma hominis
(ATCC VR-14027) | 2021010105 | Old | 2.7×106 | 8.9×105 | 1.4×105 | -1.3 |
| | 2021010108 | | | 2.1×106 | 1.1×106 | 2.2×105 |
| | 2021010205 | | | 1.8×106 | 3.5×105 | 8.6×104 |
| | 2021060105 | Mid | 8.4×105 | 7.0×105 | 1.8×105 | -0.7 |
| | 2021060108 | | | 1.2×106 | 5.7×105 | 1.6×105 |
| | 2021060201 | | | 2.0×106 | 8.9×105 | 1.1×105 |
| | 2021120101 | New | 1.7×106 | 3.9×105 | 2.1×105 | -0.9 |
| | 2021120102 | | | 2.7×106 | 8.7×105 | 1.0×105 |
| | 2021120103 | | | 2.2×106 | 2.8×105 | 9.4×104 |
8. Conclusion of the Culture-based Recovery Studies
The iClean VTM demonstrated the recovery of tested viruses, Chlamydia pneumoniae, C. trachomatis and Mycoplasma hominis in all replicates at tested incubation times and storage conditions.