(263 days)
Not Found
No
The document describes a viral transport medium and its performance in preserving viral samples. There is no mention of AI or ML technology being used in the device itself or in the analysis of the samples.
No
The device is described as a non-propagating transport device intended for the collection and transport of respiratory clinical specimens for diagnostic testing, not for treating any condition.
No
This device is a viral transport medium, which is used for the collection and transport of clinical specimens. It is designed to preserve viruses for later testing but does not perform the diagnostic assessment itself.
No
The device is a physical transport medium (liquid and tube) for biological samples, not a software application.
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 upper respiratory clinical specimens containing Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from the collection site to the testing laboratory." It also states that the media is intended to be used with "standard diagnostic/identification techniques." This clearly indicates its role in the diagnostic process.
- Device Description: The description details how the device is used to "preserves upper respiratory samples collected from a patient by placing the sample into the polymer tube containing 3 mL of media." This is a crucial step in preparing a biological sample for in vitro testing.
- Performance Studies: The document describes performance studies evaluating the device's ability to maintain viral recovery for subsequent testing using a "plaque forming assay." This assay is a standard laboratory technique used for quantifying infectious viral particles, which is an in vitro diagnostic procedure.
- Predicate Device: The mention of a predicate device (K212856 - iClean Viral Transport System (VTM-RT kit)) which is also a viral transport system, further supports its classification as an IVD. Viral transport media are commonly regulated as IVDs.
In summary, the device is designed to collect and preserve biological specimens for subsequent in vitro diagnostic testing, making it an integral part of the diagnostic process.
N/A
Intended Use / Indications for Use
The ALB Luz Viral Transport Media is intended for the collection and transport of upper respiratory clinical specimens containing Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from the collection site to the testing laboratory. The Viral Transport Media is a culture-based media that is intended to be used with standard diagnostic/identification techniques that utilize stable recoverable infectious viral particles.
Product codes
JSM
Device Description
The Viral Transport Medium (VTM) is a non-propagating transport device composed of a culturebased media without swabs. The VTM is designed to preserves upper respiratory samples collected from a patient by placing the sample into the polymer tube containing 3 mL of media. The sample and media are then secured with a leak-proof screwcap for transportation.
The VTM maintains cellular integrity and preservation of viruses when properly stored. Prior to use, vials should be stored at 2℃ to 35℃. After specimen collection, the transport tube containing the specimen can be stored for up to 48 hours at either 2-8°C or 20-25°C, for transportation to the laboratory and storage. The medium has been evaluated for storage of the following respiratory viruses, Influenza A, Respiratory Syncytial Virus (RSV), and Rhinovirus, for viral recovery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper respiratory
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
Performance of ALB LUZ Viral Transport Media was evaluated by Culture-Based Recovery Studies for viral test strains using plaque forming assay.
Viral Strains and Cell Lines:
- Influenza A virus H1N1 (ATCC VR-1520) with MDCK (ATCC CCL-34)
- Human respiratory syncytial virus (ATCC VR-1540) with MRC-5 (Instituto Adolfo Lutz CCIAL 023)
- Human rhinovirus (ATCC VR-1178) with MRC-5 (Instituto Adolfo Lutz CCIAL 023)
Methodology:
Virus stock was 10-fold serially diluted into pooled negative clinical nasal matrix. Each sample dilution was transferred into ALB LUZ Viral Transport Media by using Rayon Tip Swab and stored at 2-8℃ and 20-25℃ for 0, 24 and 48 hours respectively. Three lots of VTM (newly manufactured, mid-range, close to expiry) were used. MDCK and MRC-5 cells were seeded in 24-well plates. Viral samples from VTM were serially diluted 10-fold and added to cell monolayers in triplicate for 1 hour at 37°C. Semisolid medium containing DMEM, 1% carboxymethyl cellulose, and 1% penicillin/streptomycin antibiotics was added, and incubated at 37°C for 5-7 days. Cell fixation with 10% paraformaldehyde and staining with 1% crystal violet allowed visual counting of plaque-forming units.
Key Results:
Results were considered acceptable if the average viral recovery demonstrates any percent changes within ±90% (i.e., 1 log change).
The ALB LUZ Viral Transport Media demonstrated the recovery of tested viruses (Influenza A, RSV and RV), in all replicates at tested incubation times and storage conditions.
Viral Recovery for specimen storage at 2-8°C (Average recovery in PFU/mL):
- Influenza A:
- Lot 113364: 0 hr: 5.56E+04, 24 hrs: 5.04E+04 (-9% change), 48 hrs: 3.60E+04 (-35% change)
- Lot 111777: 0 hr: 5.76E+04, 24 hrs: 5.40E+04 (-6% change), 48 hrs: 3.67E+04 (-36% change)
- Lot 111307: 0 hr: 4.97E+04, 24 hrs: 4.97E+04 (0% change), 48 hrs: 3.07E+04 (-38% change)
- Respiratory Syncytial Virus:
- Lot 113364: 0 hr: 2.00E+06, 24 hrs: 1.78E+06 (-11% change), 48 hrs: 1.11E+06 (-45% change)
- Lot 111777: 0 hr: 1.78E+06, 24 hrs: 1.55E+06 (-13% change), 48 hrs: 1.11E+06 (-38% change)
- Lot 111307: 0 hr: 1.56E+06, 24 hrs: 1.67E+06 (7% change), 48 hrs: 7.78E+05 (-50% change)
- Rhinovirus:
- Lot 113364: 0 hr: 2.33E+06, 24 hrs: 2.44E+06 (5% change), 48 hrs: 1.11E+06 (-52% change)
- Lot 111777: 0 hr: 1.89E+06, 24 hrs: 1.89E+06 (0% change), 48 hrs: 1.22E+06 (-35% change)
- Lot 111307: 0 hr: 2.67E+06, 24 hrs: 2.45E+06 (-8% change), 48 hrs: 1.78E+06 (-33% change)
Viral Recovery for specimen storage at 20-25°C (Average recovery in PFU/mL):
- Influenza A:
- Lot 113364: 0 hr: 5.08E+04, 24 hrs: 4.70E+04 (-7% change), 48 hrs: 3.39E+04 (-33% change)
- Lot 111777: 0 hr: 4.87E+04, 24 hrs: 4.04E+04 (-17% change), 48 hrs: 2.98E+04 (-39% change)
- Lot 111307: 0 hr: 4.73E+04, 24 hrs: 3.81E+04 (-20% change), 48 hrs: 2.97E+04 (-37% change)
- Respiratory Syncytial Virus:
- Lot 113364: 0 hr: 2.22E+06, 24 hrs: 2.11E+06 (-5% change), 48 hrs: 1.33E+06 (-40% change)
- Lot 111777: 0 hr: 1.56E+06, 24 hrs: 1.33E+06 (-15% change), 48 hrs: 8.89E+05 (-43% change)
- Lot 111307: 0 hr: 1.55E+06, 24 hrs: 1.56E+06 (0% change), 48 hrs: 9.89E+05 (-36% change)
- Rhinovirus:
- Lot 113364: 0 hr: 1.89E+06, 24 hrs: 1.55E+06 (-18% change), 48 hrs: 1.33E+06 (-29% change)
- Lot 111777: 0 hr: 2.67E+06, 24 hrs: 2.11E+06 (-21% change), 48 hrs: 1.44E+06 (-46% change)
- Lot 111307: 0 hr: 2.11E+06, 24 hrs: 2.11E+06 (0% change), 48 hrs: 1.22E+06 (-42% change)
Key Metrics
Not Found
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).
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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: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION".
May 3, 2024
ALB Luz % Graziela Brum Regulatory Affairs Specialist PR Servicos Regulatorios Administrativos Ltda Rua Alice Alem Saadi, 855/2402 Ribeirao Preto, Sao Paulo 14096-570 Brazil
Re: K232454
Trade/Device Name: Viral Transport Media (VTM) Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: Class I, reserved Product Code: JSM Dated: April 4, 2024 Received: April 4, 2024
Dear Graziela Brum:
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.
Please note that if you modify your IVD in the future to exceed any of the limitations to the exemption found in 21 CFR 866.9(c), your device will require a new 510(k) prior to marketing this device in the United States and will not be exempt from the premarket notification requirements so long as it exceeds the limitations to the exemption found in 21 CFR 866.9.
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
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 product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch
2
Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232454
Device Name Viral Transport Media (VTM)
Indications for Use (Describe)
The ALB Luz Viral Transport Media is intended for the collection and transport of upper respiratory clinical specimens containing Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from the collection site to the testing laboratory. The Viral Transport Media is a culture-based media that is intended to be used with standard diagnostic/identification techniques 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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4
VIRAL TRANSPORT MEDIA
510(k) Summary: K232454
ADMINISTRATIVE INFORMATION
| Sponsor | ALB LUZ Ltda.
Rua Um, 437
Valinhos, São Paulo, Brazil 13273-200
Telephone: +55 (19) 3849-7499 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person and Preparer | Graziela Brum and Tatiana Jabor Botura
Regulatory Affairs Specialist
Passarini Regulatory Affairs
e-mail: graziela@passarini.com.br
Telephone: +55 (16) 3421 8488 |
| Data Prepared | April, 02,2024 |
DEVICE NAME AND CLASSIFICATION
| Trade Name | Viral Transport Media - VTM | |
|---|---|---|
| Common Name | Specimen Collection and Transport System | |
| Regulation Number | 21 CFR 866.2390 – Transport Culture Medium | |
| Regulatory Class | Class I, Reserved | |
| Product Code | JSM | |
| Classification Panel | MI -Microbiology |
PREDICATE DEVICE INFORMATION
Predicate Device: K212856 - iClean Viral Transport System (VTM-RT kit)
Indications For Use
The ALB Luz Viral Transport Media is intended for the collection and transport of upper respiratory clinical specimens containing Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus from the collection site to the testing laboratory. The Viral Transport Media is a culture-based media that is intended to be used with standard diagnostic/identification techniques that utilize stable recoverable infectious viral particles.
Device Description
The Viral Transport Medium (VTM) is a non-propagating transport device composed of a culturebased media without swabs. The VTM is designed to preserves upper respiratory samples collected from a patient by placing the sample into the polymer tube containing 3 mL of media. The sample and media are then secured with a leak-proof screwcap for transportation.
The VTM maintains cellular integrity and preservation of viruses when properly stored. Prior to
5
use, vials should be stored at 2℃ to 35℃. After specimen collection, the transport tube containing the specimen can be stored for up to 48 hours at either 2-8°C or 20-25°C, for transportation to the laboratory and storage. The medium has been evaluated for storage of the following respiratory viruses, Influenza A, Respiratory Syncytial Virus (RSV), and Rhinovirus, for viral recovery.
Technological Characteristics
The Viral Transport Media - VTM has a formulation that preserves viral viability. The VTM contains the following ingredients.
Hank's balanced salt solution (HBSS) Amphotericin B Colistin sulfate HEPES buffer Phenol red Bovine serum albumin fraction V (BSA) Dextrose Penicillin G potassium Gelatin powder
Hank's Balanced Salt Solution (HBSS) is further enriched with proteins and sugars for stabilization, and antimicrobial agents to inhibit the overgrowth of bacteria, fungi, and yeasts. A buffer system to maintain neutral pH and a pH indicator. Polymer screw-cap top tubes are filled with 3mL of VTM.
Substantial Equivalence Information
The subject and predicate devices comparison is described in the table below:
| Device & Predicate
| Device(s): | Device: K232454 | Predicate: K212856 |
|---|---|---|
| Device Trade Name | Viral Transport Media - VTM | iClean Viral Transport |
| System (VTM-RT kit) | ||
| Product Code and | ||
| Classification | JSM, Class I | JSM, Class I |
| General Device | ||
| Characteristic | ||
| Similarities | ||
| Intended Use/Indications | ||
| For Use | The ALB Luz Viral Transport | |
| Media is intended for the | ||
| collection and transport of upper | ||
| respiratory clinical specimens | ||
| containing Influenza A, Influenza | ||
| B, Respiratory Syncytial Virus | ||
| (RSV), and Rhinovirus from the | ||
| collection site to the testing | ||
| laboratory. The Viral Transport | ||
| Media is a culture-based media | 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 | ||
| Device & Predicate | ||
| Device(s): | Device: K232454 | Predicate: K212856 |
| that is intended to be used with | ||
| standard diagnostic/identification | ||
| techniques that utilize stable | ||
| recoverable infectious viral | ||
| particles. | 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. | ||
| Validation | Culture Media | Culture Media |
| Tube Material | Plastic Screw-Cap Tube | Plastic Screw-Cap Tube |
| Single Use Device | Yes | Yes |
| General Device | ||
| Characteristic | ||
| Differences | ||
| Shelf Life | 18 months | 12 months |
| Storage Temperature | 2 to 35°C | 20 to 25°C |
| pH | 7.4±0.2 | 7.4±0.4 |
| Supported Strains | Influenza A, | |
| Influenza B, | ||
| Respiratory | ||
| Syncytial Virus (RSV), | ||
| Rhinovirus | Adenovirus, | |
| Cytomegalovirus, | ||
| Echovirus Type 30, | ||
| Herpes SimplexVirus Type 1, | ||
| Herpes Simplex Virus | ||
| Type 2, | ||
| Influenza A, Parainfluenza 3, | ||
| Respiratory Syncytial Virus, | ||
| Chlamydia pneumoniae, | ||
| Chlamydia trachomatis, | ||
| Mycoplasma hominis | ||
| List of Ingredients | Hank's balanced salt solution | |
| (HBSS) | ||
| Amphotericin B | ||
| Colistin sulfate | ||
| HEPES buffer | ||
| Phenol red | ||
| Bovine serum albumin fraction V | ||
| (BSA) | ||
| Dextrose | ||
| Penicillin G potassium | ||
| Gelatin powder | Hank's balanced salt solution | |
| (HBSS) | ||
| Amphotericin B | ||
| Colistin | ||
| HEPES buffer | ||
| Phenol red | ||
| Bovine Serum Albumin | ||
| (BSA) | ||
| Gentamicin sulfate | ||
| L-Glutamic acid |
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7
Shelf life
The shelf-life for the ALB LUZ Viral Transport Media was established to be 18 months from the date of manufacture when stored in a clean, dry, ventilated environment at 2 - 35°C. The shelf-life study was conducted by using real-time aging performance test for 18 months. In this study, the shelf life was evaluated for physical stability of appearance and volume, and pH stability during the period of storage.
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- Physical Stability: To evaluate physical stability, any changes in appearance in color, turbidity and volume of the ALB LUZ Viral Transport Media were physically or visually examined at storage time points T = 0, 3, 6, 9, 12, 15, and 18 months. Three lots were tested for physical stability at storage conditions of 2°C and 35°C. At each time point, appearance of the product was inspected visually which appeared clear with slight precipitation and maintained an orange-pink color (i.e., no changes in color) and no changes in liquid media volume. All results support the claim that the ALB LUZ Viral Transport Media is physically or visually stable for 18 months.
-
- pH Stability: To evaluate product stability, the pH of the ALB LUZ Viral Transport Media was tested at storage time points T = 0, 3, 6, 9, 12, 15, and 18 months. Three lots were tested for pH stability at storage condition of 2℃ and 35℃. At each time point, the pH was measured by immersing the pH meter electrode into each ALB LUZ Viral Transport Media by adjusting the temperature to 25°C. For all the tubes tested, the pH measurement was within the acceptable pH range of 7.2 to 7.6. All results support the claim for pH stability of the ALB LUZ Viral Transport Media for 18 months.
The results for physical stability and pH stability collectively support the 18-month stability claim for the ALB LUZ Viral Transport Media.
-
- Sterilization:
The ALB LUZ Viral Transport Media is not claimed to be sterile nor is it intended to be sterilized by the end user. To reduce the contamination, the transport media is filtered using a 0.22 um sterile filter membrane and then 3 ml aliquot is aseptically transferred into individual sterile conical screw-capped tubes. A microbial contamination check was conducted by incubating the tubes for 48 hours at 35°C ± 2°C followed by transferring 100 µL of transport media into BHI media and incubating for 24 hours at 35°C ± 2°C. No growth was observed on any of the tested media.
- Sterilization:
Performance testing
Performance of ALB LUZ Viral Transport Media was evaluated by Culture-Based Recovery Studies for viral test strains using plaque forming assay. The viral strains and cell lines used for the plaque forming assay are shown in the Table 1.
| Virus Strains | Cell Lines |
|---|---|
| Influenza A virus H1N1 (ATCC VR-1520) | MDCK (ATCC CCL-34) |
| Human respiratory syncytial virus (ATCC VR-1540) | MRC-5 (Instituto Adolfo Lutz CCIAL 023) |
| Human rhinovirus (ATCC VR-1178) | MRC-5 (Instituto Adolfo Lutz CCIAL 023) |
Table 1. Viral strains and Cell Lines used for the plaque forming assay.
8
To perform the recovery assay, virus stock was 10-fold serially diluted into pooled negative clinical nasal matrix. Each sample dilution was transferred into ALB LUZ Viral Transport Media by using Rayon Tip Swab and stored at 2-8℃ and 20-25℃ for 0, 24 and 48 hours respectively. Three lots of VTM with newly manufactured, mid-range lot and close to expiry lots were used to evaluate viral recovery. For tissue culture, MDCK (ATCC CCL-34) and MRC-5 (Instituto Adolfo Lutz CCIAL 023) were seeded in 24-well plates and grown to a confluent monolayer. To perform the plaque forming assay, the viral samples from ALB LUZ Viral Transport Media were serially diluted 10-fold and added to the monolayer in triplicate and allowed for virus adsorption by incubating the plates for 1 hour at 37°C. Semisolid medium containing DMEM, 1% carboxymethyl cellulose, and 1% penicillin/streptomycin antibiotics were added to each well and incubated at 37°C for 5-7 days. For counting the plaques developed, the cell fixation was performed with 10% paraformaldehyde and the staining of cell monolayer was performed with 1% crystal violet. Plaque-forming units were counted visually. The viral titer of each sample was recorded and calculated in plaque-forming units per mL (PFU/mL) and the results from the triplicates were provided as an average PFU/mL for 0, 24 and 48 hours. Results were considered acceptable if the average viral recovery demonstrates any percent changes within ±90% (i.e.,1 log change).
The results are presented in the Table 2 and Table 3 below. Any reduction in the viral count in the timepoints was shown as percent changes and -ve indicates reduction.
| Viral Strain
| Tested | Lots | Average recovery in PFU/mL | Percent | Percent | ||
|---|---|---|---|---|---|---|
| 0 hr. | 24 hrs. | 48 hrs. | changes | |||
| (0 to 24 hrs.) |
- | changes
(0 to 48 hrs.) * |
| Influenza A | 113364 | 5.56E+04 | 5.04E+04 | 3.60E+04 | -9% | -35% |
| | 111777 | 5.76E+04 | 5.40E+04 | 3.67E+04 | -6% | -36% |
| | 111307 | 4.97E+04 | 4.97E+04 | 3.07E+04 | 0% | -38% |
| Respiratory
Syncytial Virus | 113364 | 2.00E+06 | 1.78E+06 | 1.11E+06 | -11% | -45% |
| | 111777 | 1.78E+06 | 1.55E+06 | 1.11E+06 | -13% | -38% |
| | 111307 | 1.56E+06 | 1.67E+06 | 7.78E+05 | 7% | -50% |
| Rhinovirus | 113364 | 2.33E+06 | 2.44E+06 | 1.11E+06 | 5% | -52% |
| | 111777 | 1.89E+06 | 1.89E+06 | 1.22E+06 | 0% | -35% |
| | 111307 | 2.67E+06 | 2.45E+06 | 1.78E+06 | -8% | -33% |
Table 2. Viral Recovery for specimen storage at 2-8°C.
- -ve indicates reduction
Table 3. Viral Recovery for specimen storage at 20-25°C.
| Viral Strain
| Tested | Lots | Average recovery in PFU/mL | Percent | Percent | ||
|---|---|---|---|---|---|---|
| 0 hr. | 24 hrs. | 48 hrs. | changes | |||
| (0 to 24 hrs.) |
- | changes
(0 to 48 hrs.) * |
| Influenza A | 113364 | 5.08E+04 | 4.70E+04 | 3.39E+04 | -7% | -33% |
| | 111777 | 4.87E+04 | 4.04E+04 | 2.98E+04 | -17% | -39% |
| | 111307 | 4.73E+04 | 3.81E+04 | 2.97E+04 | -20% | -37% |
| Respiratory
Syncytial Virus | 113364 | 2.22E+06 | 2.11E+06 | 1.33E+06 | -5% | -40% |
| | 111777 | 1.56E+06 | 1.33E+06 | 8.89E+05 | -15% | -43% |
| | 111307 | 1.55E+06 | 1.56E+06 | 9.89E+05 | 0% | -36% |
| Rhinovirus | 113364 | 1.89E+06 | 1.55E+06 | 1.33E+06 | -18% | -29% |
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| 111777 | 2.67E+06 | 2.11E+06 | 1.44E+06 | -21% | -46% |
|---|---|---|---|---|---|
| 111307 | 2.11E+06 | 2.11E+06 | 1.22E+06 | 0% | -42% |
- -ve indicates reduction
The ALB LUZ Viral Transport Media demonstrated the recovery of tested viruses (Influenza A, RSV and RV), in all replicates at tested incubation times and storage conditions.
Conclusion:
The documentation submitted in this premarket notification demonstrates that the subject device K232454 has comparable features and performance and is substantially equivalent to the predicate device.