(254 days)
Not Found
No
The device description and performance studies focus on the chemical composition and biological recovery capabilities of a viral transport medium. There is no mention of AI, ML, image processing, or any computational analysis of data.
No
This device is a transport medium for collecting and preserving clinical specimens containing viruses, chlamydiae, mycoplasmas, and ureaplasmas for diagnostic testing, not a device used to provide therapy or treatment to a patient.
No
Explanation: The KaiBiLi Extended ViralTrans is a transport medium intended for the collection and transport of clinical specimens. It sustains the viability of viruses and bacteria, but it does not perform any diagnostic analysis itself. It is used as a preliminary step to prepare samples for diagnostic tests, such as culture or other assays, which would then be performed at a separate "test site".
No
The device description clearly states it is a culture-based medium supplied in a plastic vial with a screw cap, containing liquid medium and glass beads, and potentially collection swabs. These are all physical components, not software.
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 of clinical specimens containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the test site." This is a key characteristic of an IVD, as it is used to collect and transport biological specimens for subsequent diagnostic testing.
- Device Description: The description details the composition of the transport medium, which is designed to maintain the viability of specific microorganisms for diagnostic purposes.
- Performance Studies: The document describes performance studies that evaluate the ability of the medium to recover and maintain the viability of various viruses and bacteria. These studies are conducted to demonstrate the suitability of the device for its intended diagnostic use.
- Comparison to Predicate Device: The mention of a predicate device (Copan Universal Transport Medium (UTM-RT) System, K042970) further indicates that this device is being compared to another device already classified as an IVD.
While the device itself is a transport medium and not a test that provides a diagnostic result, it is an essential component in the process of performing in vitro diagnostic tests on the collected specimens. Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
The KaiBiLi Extended ViralTrans is intended for the collection of clinical specimens containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the test site. The KaiBiLi Extended ViralTrans is a culture-based medium that has been validated with multiple sample types and can be used to process clinical specimens using standard laboratory operating procedures for culture of clinical specimens or with other assays that utilize stable recoverable infectious viral particles or bacteria.
Product codes
JSM
Device Description
The KaiBiLi Extended ViralTrans is room temperature stable and can sustain the viability of virus, chlamydiae, mycoplasma and ureaplasma when transported at 2-8°C or 20-25°C. The product can maintain proper pH environment and inhibit the growth of indigenous microbiota.
KaiBiLi Extended ViralTrans consists of modified Hank's balanced salt solution supplemented with bovine serum albumin, cysteine, glutamic acid, sucrose and HEPES. The HEPES buffer protects against pH changes. Phenol red is used as a pH indicator. Sucrose aids in the preservation of organism viability. To minimize the contamination of commensal organisms, Vancomycin, Econazole Nitrate, and Polymyxin B are incorporated into the medium formula.
KaiBiLi Extended ViralTrans is supplied as one plastic flat-bottom vial along with a screw cap for safely containing and transporting biological specimens. The vial is filled with either 1 mL or 3 mL of transport medium and glass beads, or in a kit format together with collection swabs.
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The shelf life for the KaiBiLi Extended ViralTrans was determined to be 12 months from the date of manufacture when stored at temperature 2-8℃ and 20-25℃. The shelf life was established using real-time aging performance test at T= 0, 6, 9, 11, and 12 months using three lots each of the 1 mL and 3 mL configurations (total of 6 lots). At each time point, appearance, volume, pH, and bacteriostatic performance were assessed.
Performance of the KaiBiLi Extended ViralTrans media was evaluated using culture-based recovery studies for viruses and bacteria at different incubation times and temperatures.
For Recovery Studies, virus titer (TCIDso/mL) was quantified to evaluate the recovery of the following viruses: Herpes Simplex Virus Type 1 (ATCC VR-733; HSV-1), Herpes Simplex Virus Type 2 (ATCC VR-734; HSV-2), Respiratory Syncytial Virus (ATCC VR-26; RSV), Cytomegalovirus (ATCC VR-977), Adenovirus (ATCC VR-3), Parainfluenza 3 (ATCC VR-93), Influenza A (ATCC VR-822; Flu A), and Varicella Zoster Virus (ATCC VR-1832; VZV). Recovery of Chlamydophila pneumoniae (ATCC VR-2282) was evaluated using Fluorescent Foci Count method (IFU/mL). Recovery of Mycoplasma pneumoniae (ATCC 15531) and Ureaplasma urealyticum (ATCC 27618) was evaluated using the Swab Elution and Roll Plate methods (CFU/mL). Performance evaluation was carried out in three lots of media that represent newly manufactured, middle-aged, and recently expired media. Negative clinical matrix pools were contrived from a minimum of five donors. Matrix pools were determined to be negative prior to use in the specimen stability recovery studies.
Viral stocks were diluted into two different dilutions into the corresponding pooled negative clinical matrix and 100 µL of each dilution was transferred onto a dry sterile swab and placed into the KaiBiLi Extended ViralTrans media tubes in triplicate and stored at 2-8ºC and 20-25°C for 0, 24, and 48 hours. At each incubation time point, the sample was vortexed and a 200µL aliquot was removed for the recovery study. The recovery study was conducted using suitable host cells and tissue culture media.
Bacterial stocks were diluted into four different dilutions into the corresponding pooled negative clinical matrix and 100 µL of each dilution was transferred onto a dry sterile swab and placed into the KaiBiLi Extended ViralTrans media tubes in duplicate and stored at 2-8°C and 20-25°C for 0, 24, and 48 hours. For the swab elution method, at each incubation time point, each sample was vortexed, serially diluted and a 100µL aliquot was removed for the recovery study. The recovery study was conducted using Mycoplasma pneumoniae culture medium for M. pneumoniae and Ureaplasma urealyticum culture medium for U. urealyticum. For the roll-plate method, a single dilution was tested in triplicate by streaking the swab from the various KaiBiLi Extended ViralTrans media tube incubation time point over the agar media specified above and incubating for CFU enumeration.
The changes (any increase or decrease) in the recovery between time points (each time point compared to time point 0) were presented in percent values or log10 change (negative for decrease and positive for increase). Any change that was within one log difference (+/-90%) was considered acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Recovery of viruses and bacteria at 2-8°C storage:
- HSV-1: -20% (0-24 hrs), -38% (0-48 hrs).
- HSV-2: -18% (0-24 hrs), -46% (0-48 hrs).
- RSV: -14% (0-24 hrs), -45% (0-48 hrs).
- Cytomegalovirus (blood): -19% (0-24 hrs), -44% (0-48 hrs).
- Cytomegalovirus (urine): -19% (0-24 hrs), -45% (0-48 hrs).
- Adenovirus: -20% (0-24 hrs), -36% (0-48 hrs).
- Parainfluenza 3: -19% (0-24 hrs), -33% (0-48 hrs).
- Flu A: -19% (0-24 hrs), -35% (0-48 hrs).
- VZV: -14% (0-24 hrs), -41% (0-48 hrs).
- C. pneumoniae: -21% (0-24 hrs), -39% (0-48 hrs).
- M. pneumoniae (swab elution): -0.03 log10 (0-24 hrs), -0.45 log10 (0-48 hrs).
- U. urealyticum (swab elution): -0.08 log10 (0-24 hrs), -0.53 log10 (0-48 hrs).
- M. pneumoniae (roll plate): -0.13 log10 (0-24 hrs), -0.42 log10 (0-48 hrs).
- U. urealyticum (roll plate): -0.15 log10 (0-24 hrs), -0.48 log10 (0-48 hrs).
Recovery of viruses and bacteria at 20-25°C storage:
- HSV-1: -21% (0-24 hrs), -41% (0-48 hrs).
- HSV-2: -20% (0-24 hrs), -48% (0-48 hrs).
- RSV: -21% (0-24 hrs), -48% (0-48 hrs).
- Cytomegalovirus (blood): -20% (0-24 hrs), -45% (0-48 hrs).
- Cytomegalovirus (urine): -20% (0-24 hrs), -48% (0-48 hrs).
- Adenovirus: -21% (0-24 hrs), -41% (0-48 hrs).
- Parainfluenza 3: -20% (0-24 hrs), -35% (0-48 hrs).
- Flu A: -20% (0-24 hrs), -38% (0-48 hrs).
- VZV: -17% (0-24 hrs), -45% (0-48 hrs).
- C. pneumoniae: -21% (0-24 hrs), -39% (0-48 hrs).
- M. pneumoniae (swab elution): -0.03 log10 (0-24 hrs), -0.46 log10 (0-48 hrs).
- U. urealyticum (swab elution): -0.10 log10 (0-24 hrs), -0.56 log10 (0-48 hrs).
- M. pneumoniae (roll plate): -0.15 log10 (0-24 hrs), -0.46 log10 (0-48 hrs).
- U. urealyticum (roll plate): -0.23 log10 (0-24 hrs), -0.50 log10 (0-48 hrs).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2023
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. Guan Emma, Int'l RA #139 10th Street (East) Hangzhou Economic And Technology Development Zone Hangzhou, 310018, China
Re: K231027
Trade/Device Name: KaiBiLi Extended ViralTrans Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: Class I, reserved Product Code: JSM Dated: April 11, 2023 Received: April 11, 2023
Dear Guan Emma:
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
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 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.
Natasha Griffin -S
O.B.O. 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
2
Indications for Use
510(k) Number (if known) K231027
Device Name KaiBiLi Extended ViralTrans
Indications for Use (Describe)
The KaiBiLi Extended ViralTrans is intended for the collection of clinical specimens containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the test site. The KaiBiLi Extended ViralTrans is a culture-based medium that has been validated with multiple sample types and can be used to process clinical specimens using standard laboratory operating procedures for culture of clinical specimens or with other assays that utilize stable recoverable infectious viral particles or bacteria.
| Type of Use (Select one or both, as applicable) |
|---|
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3
510(k) Summary
Dec.18, 2023
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
| Submitted by | Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.
#139, 10th Street (East), Hangzhou Economic and Technology
Development Zone, Hangzhou Zhejiang, CN 310018
Tel : +86-571-87818163 |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Emma Guan
Int'l RA
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.
#139, 10th Street (East), Hangzhou Economic and Technology
Development Zone, Hangzhou Zhejiang, CN 310018
Telephone: +86 571-86736901-892
Email: yguan@hgb.com.cn |
| Trade Name | KaiBiLi Extended ViralTrans |
| Common Name | Transport culture medium |
| Review Panel | Microbiology |
| Regulation | 21 CFR 866.2390 |
| Class | Class I |
| Product Code | JSM |
| Predicate Device | K042970 |
1. Device Description
The KaiBiLi Extended ViralTrans is room temperature stable and can sustain the viability of virus, chlamydiae, mycoplasma and ureaplasma when transported at 2-8°C or 20-25°C. The product can maintain proper pH environment and inhibit the growth of indigenous microbiota.
KaiBiLi Extended ViralTrans consists of modified Hank's balanced salt solution supplemented with bovine serum albumin, cysteine, glutamic acid, sucrose and HEPES. The HEPES buffer protects against pH changes. Phenol red is used as a pH indicator. Sucrose aids in the preservation of organism viability. To minimize the contamination of commensal organisms, Vancomycin, Econazole Nitrate, and Polymyxin B are incorporated into the medium formula.
4
2. Intended Use and Indication for Use
The KaiBiLi Extended ViralTrans is intended for the collection and transportation of clinical specimens containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the test site. The KaiBiLi Extended ViralTrans is a culture-based medium that has been validated with multiple sample types and can be used to process clinical specimens using standard laboratory operating procedures for culture of clinical specimens or with other assays that utilize stable recoverable infectious viral particles or bacteria.
3. Device Specification
KaiBiLi Extended ViralTrans is supplied as one plastic flat-bottom vial along with a screw cap for safely containing and transporting biological specimens. The vial is filled with either 1 mL or 3 mL of transport medium and glass beads, or in a kit format together with collection swabs.
The KaiBiLi Extended ViralTrans is offered with one of the following configurations :
| Cat. No. | Description |
|---|---|
| M221001 | KaiBiLi Extended ViralTrans 3 mL- |
| 3 mL viral transport medium/vial | |
| M221006 | KaiBiLi Extended ViralTrans 3 mL with minitip swab- |
| 3 mL viral transport medium/vial, with a minitip swab | |
| M221007 | KaiBiLi Extended ViralTrans 3 mL with regular swab- |
| 3 mL viral transport medium/vial, with a regular swab | |
| M221008 | KaiBiLi Extended ViralTrans 3 mL with regular swab and minitip swab- |
| 3 mL viral transport medium/vial, with a regular swab and a minitip swab | |
| M221009 | KaiBiLi Extended ViralTrans 1 mL- |
| 1 mL viral transport medium/vial | |
| M221010 | KaiBiLi Extended ViralTrans 1 mL with minitip swab- |
| 1 mL viral transport medium/vial, with a minitip swab | |
| M221011 | KaiBiLi Extended ViralTrans 1 mL with regular swab- |
| 1 mL viral transport medium/vial, with a regular swab | |
| M221012 | KaiBiLi Extended ViralTrans 1 mL with regular swab and minitip swab- |
| 1 mL viral transport medium/vial, with a regular swab and a minitip swab |
Media Formulation:
- Hank's Balanced Salts
- HEPES Buffer
- BSA
- L-Cysteine .
- L-Glutamic Acid .
- · Sucrose
- Vancomycin
- Econazole Nitrate
- Polymyxin B
- Phenol Red
4. Substantial Equivalence
The KaiBiLi Extended ViralTrans is compared with the predicate device, K042970, in intended use, medium formulation, product configuration, shelf life, packaging and volume, etc. The safety and effectiveness of the KaiBiLi Extended ViralTrans is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification. Below is a summary of comparison table between KaiBiLi Extended ViralTrans and predicate device K042970:
5
| Device & Predicate
| Device(s): | Device: K231027 | Predicate: K042970 |
|---|---|---|
| Device Trade Name | KaiBiLi Extended | |
| ViralTrans | Copan Universal | |
| Transport Medium (UTM- | ||
| RT) System | ||
| General Device | ||
| Characteristic | ||
| Similarities | ||
| Intended Use/Indications | ||
| For Use | The KaiBiLi Extended | |
| ViralTrans is intended for | ||
| the collection and | ||
| transportation of clinical | ||
| specimens containing | ||
| viruses, chlamydiae, | ||
| mycoplasmas and | ||
| ureaplasmas from the | ||
| collection site to the test | ||
| site. The KaiBiLi | ||
| Extended ViralTrans is a | ||
| culture-based medium | ||
| that has been validated | ||
| with multiple sample | ||
| types and can be used to | ||
| process clinical | ||
| specimens using | ||
| standard laboratory | ||
| operating procedures for | ||
| culture of clinical | ||
| specimens 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 | 2-8°C and 20-25°C | Same |
| Product configuration | Medium tubes; kit with | |
| medium tubes and swab | ||
| options | Same | |
| Single use device | Yes | Same |
| Container | Tube; plastic; self- | |
| standing with a screw | ||
| cap; with glass beads | Same | |
| Shelf Life | 12 months | Same |
| pH | 7.3 +/-0.2 | Same |
| General Device | ||
| Characteristic | ||
| Differences | ||
| Media Formulation | Hank's Balanced Salts | |
| HEPES Buffer | ||
| BSA | ||
| L-Cysteine | ||
| L-Glutamic Acid | ||
| Sucrose | ||
| Vancomycin | ||
| Econazole Nitrate | ||
| Polymyxin B | ||
| Phenol Red | Hank's Balanced Salts | |
| Bovine Serum Albumin | ||
| L-Cysteine | ||
| Gelatin | ||
| Sucrose | ||
| L-Glutamic Acid | ||
| HEPES Buffer | ||
| Vancomycin | ||
| Amphotericin B | ||
| Colistin | ||
| Phenol Red | ||
| Supported Strains | Adenovirus | |
| Cytomegalovirus | ||
| Herpes Simplex Virus | ||
| Type 1 | ||
| Herpes Simplex Virus | ||
| Type 2 | ||
| Influenza A | ||
| Parainfluenza 3 | ||
| Respiratory Syncytial | ||
| Virus | ||
| Varicella Zoster Virus | ||
| Mycoplasma | ||
| pneumoniae | ||
| Chlamydia pneumoniae | ||
| Ureaplasma urealyticum | 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 | ||
| Medium volume | 1 mL or 3 mL | 3 mL or 6 mL |
6
As shown with the comparison above, KaiBiLi Extended ViralTrans and the predicate's specification, safety and performance are comparable.
7
5. Shelf Life
The shelf life for the KaiBiLi Extended ViralTrans was determined to be 12 months from the date of manufacture when stored at temperature 2-8℃ and 20-25℃. The shelf life of the KaiBiLi Extended ViralTrans was established using real-time aging performance test at time points T= 0, 6, 9, 11, and 12 months. Three lots each of the KaiBiLi Extended ViralTrans media at 1 mL and 3 mL configurations (a total of 6 lots) were evaluated. At each time point, appearance, volume, pH, and bacteriostatic performance were assessed.
-
(1) Appearance and volume
To evaluate appearance, stability of the different lots of KaiBiLi Extended ViralTrans were physically or visually examined. The appearance of the product was observed to be a clear, pink, transparent liquid media with no turbidity or sedimentation. Volume range of 2.7-3.3 mL for the 3 mL media configuration or 0.9-1.1 mL for the 1 mL media configuration were observed. All lots tested at each time point passed the criteria for appearance and net volume. -
(2) pH Stability
The pH of the media was used as one of the indicators to support product stability. For all the tubes at each time point and with each lot, the pH was within the targeted pH range of 7.3 ± 0.2 after 12 months of storage. -
(3) Bacteriostatic performance
KaiBiLi Extended ViralTrans contains Vancomycin, Econazole Nitrate and Polymyxin B to inhibit growth of bacteria or yeast. At each time point, the KaiBiLi Extended ViralTrans were inoculated with the following microorganisms: E. Coli (1.0x103 CFU/mL), Staphylococcus aureus (1.0x103 CFU/mL), Streptococcus pyogenus (1.0x103 CFU/mL), and Candida albicans (1.0x103 CFU/mL). The KaiBiLi Extended ViralTrans had no microorganism growth after 48 hours growth at 37°C. All lots tested at each time point passed the criteria for bacteriostasis.
6. Performance Testing - Recovery Studies
Performance of the KaiBiLi Extended ViralTrans media was evaluated using culture-based recovery studies for viruses and bacteria at different incubation times and temperatures.
For Recovery Studies, virus titer (TCIDso/mL) was quantified to evaluate the recovery of the following viruses in the corresponding matrices listed in Table 1 below: Herpes Simplex Virus Type 1 (ATCC VR-733; HSV-1), Herpes Simplex Virus Type 2 (ATCC VR-734; HSV-2), Respiratory Syncytial Virus (ATCC VR-26; RSV), Cytomegalovirus (ATCC VR-977), Adenovirus (ATCC VR-3), Parainfluenza 3 (ATCC VR-93), Influenza A (ATCC VR-822; Flu A), and Varicella Zoster Virus (ATCC VR-1832; VZV). Recovery of Chlamydophila pneumoniae (ATCC VR-2282) was evaluated using Fluorescent Foci Count method (IFU/mL). Recovery of Mycoplasma pneumoniae (ATCC 15531) and Ureaplasma urealyticum (ATCC 27618) was evaluated using the Swab Elution and Roll Plate methods (CFU/mL). Performance evaluation was carried out in three lots of media that represent newly manufactured, middle-aged, and recently expired media. Negative clinical matrix pools were contrived from a minimum of five donors. Matrix pools were determined to be negative prior to use in the specimen stability recovery studies.
8
| Negative Clinical
| specimen Type | Microbial Testing |
|---|---|
| Skin | Herpes Simplex Virus Type 1 |
| Skin | Varicella Zoster Virus |
| Genital specimens | Herpes Simplex Virus Type 2 |
| Nasopharynx | Respiratory Syncytial Virus |
| Nasopharynx | Adenovirus |
| Nasopharynx | Parainfluenza3 |
| Nasopharynx | Influenza A |
| Throat | Chlamydophila pneumoniae |
| Throat | Mycoplasma pneumoniae |
| Blood | Cytomegalovirus |
| Urine | Cytomegalovirus |
| Urine | Ureaplasma urealyticum |
Table 1: Negative clinical matrix used for organism validation.
Viral stocks were diluted into two different dilutions into the corresponding pooled negative clinical matrix and 100 µL of each dilution was transferred onto a dry sterile swab and placed into the KaiBiLi Extended ViralTrans media tubes in triplicate and stored at 2-8ºC and 20-25°C for 0, 24, and 48 hours. At each incubation time point, the sample was vortexed and a 200µL aliquot was removed for the recovery study. The recovery study was conducted using suitable host cells and tissue culture media. For tissue culture, host cells were plated in a microwell plate and allowed to adhere for 48-72 hours prior to recovery testing. Hep-2 cells were used for HSV-1, RSV, and C. pneumoniae; Vero cells were used for HSV-2; MRC-5 cells were used for Cytomegalovirus and VZV: A549 cells were used for Adenovirus: LLC-MK2 cells were used for Parainfluenza 3; MDCK cells were used for Flu A.
Bacterial stocks were diluted into four different dilutions into the corresponding pooled neqative clinical matrix and 100 µL of each dilution was transferred onto a dry sterile swab and placed into the KaiBiLi Extended ViralTrans media tubes in duplicate and stored at 2-8°C and 20-25°C for 0, 24, and 48 hours. For the swab elution method, at each incubation time point, each sample was vortexed, serially diluted and a 100µL aliquot was removed for the recovery study. The recovery study was conducted using Mycoplasma pneumoniae culture medium for M. pneumoniae and Ureaplasma urealyticum culture medium for U. urealyticum. For the roll-plate method, a single dilution was tested in triplicate by streaking the swab from the various KaiBiLi Extended ViralTrans media tube incubation time point over the agar media specified above and incubating for CFU enumeration.
Viral titer for the viruses and foci counts for C. pneumoniae were evaluated, and CFU was enumerated for M. pneumoniae and U. urealyticum. The average recovery was calculated
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as mean viral titer (TCID50/mL), mean foci count (IFU/mL), or mean CFU/mL, respectively, for each storage temperature and time points. The changes (any increase or decrease) in the recovery between time points (each time point compared to time point 0) were presented in percent values or logio change (negative for decrease and positive for increase). Any change that was within one log difference (+/-90%) was considered acceptable. Results were combined for all the lots, irrespective of age, as all changes were acceptable. The results are presented in Tables 2 and 3 below.
| Average recovery | Percent observed changes | ||||
|---|---|---|---|---|---|
| Test strain | (TCID50/mL) | (-ve indicate reduction) | |||
| HSV-1 | 3.53x103 | 2.84x103 | 2.23x103 | -20% | -38% |
| HSV-2 | 4.31x103 | 3.54x103 | 2.37x103 | -18% | -46% |
| RSV | 1.29x104 | 1.13x104 | 7.14x103 | -14% | -45% |
| Cytomegalovirus¹ | 5.89x103 | 4.75x103 | 3.32x103 | -19% | -44% |
| Cytomegalovirus2 | 5.87x103 | 4.76x103 | 3.26x103 | -19% | -45% |
| Adenovirus | 1.31x105 | 1.06x105 | 8.53x104 | -20% | -36% |
| Parainfluenza 3 | 2.70x104 | 2.19x104 | 1.83x104 | -19% | -33% |
| Flu A | 1.46x104 | 1.19x104 | 9.71x103 | -19% | -35% |
| VZV | 1.25x103 | 1.08x103 | 7.37x102 | -14% | -41% |
| Test strain | Average recovery | Percent observed changes | |||
| (IFU/mL) | (-ve indicate reduction) | ||||
| C. pneumoniae | 3.40x105 | 2.72x105 | 2.12x105 | -21% | -39% |
| Test strain | Average recovery using swab elution method | Log10 observed changes | |||
| (CFU/mL) | (-ve indicate reduction) | ||||
| M. pneumoniae | 6.36x104 | 5.89x104 | 2.43x104 | -0.03 | -0.45 |
| U. urealyticum | 6.74x104 | 5.81x104 | 2.19x104 | -0.08 | -0.53 |
| Test strain | Average recovery using roll plate method | Log10 observed changes | |||
| (CFU) | (-ve indicate reduction) | ||||
| M. pneumoniae | 2.97x102 | 2.18x102 | 1.13x102 | -0.13 | -0.42 |
| U. urealyticum | 2.98x102 | 2.11x102 | 9.80x101 | -0.15 | -0.48 |
Table 2: Recovery of viruses and bacteria at 2-8°C storage
1 Cytomegalovirus recovery in blood; 2 Cytomegalovirus recovery in urine
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| Table 3. Recovery of viruses and bacteria at 20-25°C storage | |||||
|---|---|---|---|---|---|
| Test strain | Average recovery (TCID50/mL) | Percent observed changes (-ve indicate reduction) | |||
| 0 hrs | 24 hrs | 48 hrs | 0-24 hrs | 0-48 hrs | |
| HSV-1 | 3.53x10³ | 2.83x10³ | 2.14x10³ | -21% | -41% |
| HSV-2 | 4.31x10³ | 3.49x10³ | 2.30x10³ | -20% | -48% |
| RSV | 1.29x10⁴ | 1.02x10⁴ | 6.76x10³ | -21% | -48% |
| Cytomegalovirus¹ | 5.89x10³ | 4.71x10³ | 3.22x10³ | -20% | -45% |
| Cytomegalovirus² | 5.87x10³ | 4.73x10³ | 3.07x10³ | -20% | -48% |
| Adenovirus | 1.31x10⁵ | 1.05x10⁵ | 7.89x10⁴ | -21% | -41% |
| Parainfluenza 3 | 2.70x10⁴ | 2.15x10⁴ | 1.78x10⁴ | -20% | -35% |
| Flu A | 1.46x10⁴ | 1.17x10⁴ | 9.39x10³ | -20% | -38% |
| VZV | 1.25x10³ | 1.04x10³ | 6.86x10² | -17% | -45% |
| Test strain | Average recovery (IFU/mL) | Percent observed changes (-ve indicate reduction) | |||
| 0 hrs | 24 hrs | 48 hrs | 0-24 hrs | 0-48 hrs | |
| C. pneumoniae | 3.40x10⁵ | 2.69x10⁵ | 2.09x10⁵ | -21% | -39% |
| Test strain | Average recovery using swab elution method (CFU/mL) | Log₁₀ observed changes (-ve indicate reduction) | |||
| 0 hrs | 24 hrs | 48 hrs | 0-24 hrs | 0-48 hrs | |
| M. pneumoniae | 6.36x10⁴ | 5.92x10⁴ | 2.40x10⁴ | -0.03 | -0.46 |
| U. urealyticum | 6.74x10⁴ | 5.60x10⁴ | 2.04x10⁴ | -0.10 | -0.56 |
| Test strain | Average recovery using roll plate method (CFU) | Log₁₀ observed changes (-ve indicate reduction) | |||
| 0 hrs | 24 hrs | 48 hrs | 0-24 hrs | 0-48 hrs | |
| M. pneumoniae | 2.47x10² | 2.09x10² | 1.03x10² | -0.15 | -0.46 |
| U. urealyticum | 2.98x10² | 1.74x10² | 9.40x10¹ | -0.23 | -0.50 |
Table 3: Recovery of viruses and bacteria at 20-25°C storage
1 Cytomegalovirus recovery in blood; 2 Cytomegalovirus recovery in urine
7. Conclusion
The KaiBiLi Extended ViralTrans media demonstrated the recovery of tested viruses (HSV-1, HSV-2, RSV, Cytomegalovirus, Adenovirus, Parainfluenza, Flu A, and VZV) and bacteria (C. pneumoniae, M. pneumoniae, and U. urealyticum) at an acceptable rate when stored at 2-8°C and 20-25°C up to 48 hours.
Based on the indications for use, technological characteristics, safety and performance testing, the subject device, the KaiBiLi Extended ViralTrans, meets the requirements that are considered essential for its intended use and is substantially equivalent to the legally marketed predicate device, Copan Universal Transport Medium (UTM-RT) System , K042970.