(1318 days)
The Azer Scientific Universal Transport Medium is for the collection and transport of upper respiratory clinical specimens. containing respiratory viruses from the to the testing laboratory. The Azer Scientific Universal Transport Medium is a culture-based media that can be processed usincal laboratory operating procedures for the isolation and detection of upper respiratory viruses including Influenza A, Respiratory Syncytial Virus (RSV) and Adenovirus.
The Azer Scientific Universal Transport Medium includes a plastic screw-cap tube with conical bottom containing 3 mL of transport medium and three, 3 mm size glass beads. Azer Scientific Universal Transport Medium tubes can be supplied alone or in a kit format with one of three different collection swab options in a sterile peel pouch.
The provided document is a 510(k) Premarket Notification for the Azer Scientific Universal Transport Medium. It does not describe an AI/ML powered device, but rather a universal transport medium for the collection and transport of respiratory clinical specimens containing viruses. Therefore, many of the requested sections related to AI/ML device performance and testing (e.g., human reader studies, AI effect size, training set details, expert qualifications for ground truth) are not applicable.
However, I can provide the available information regarding the acceptance criteria and the study proving the device meets these criteria, focusing on the device's intended function: viral recovery and stability.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Internal) | Reported Device Performance (Azer Scientific Universal Transport Medium) |
|---|---|
| Shelf-life Stability: | |
| 12 months from manufacture when stored at 2-25°C. | Met: The shelf-life was determined to be 12 months from the date of manufacture when stored at 2-25°C. Studies covered 0, 3, 6, 9, and 12-month time points. |
| Appearance: No significant color change (pink, transparent), precipitate, particulates, or cloudy appearance. | Met: All lots tested at each time point passed the criteria for appearance when held at 2-8°C and 20-25°C. |
| pH Stability: pH within the targeted range of 7.3 ± 0.2. | Met: For all tubes at each time point and each lot, the pH was within the targeted range of 7.3 ± 0.2 when held at 2-8°C and 20-25°C. |
| Microbial Contamination: No growth contaminants after overnight incubation at 37±2°C. | Met: All lots tested at each time point and each temperature passed the criteria for no contamination (no growth) when held at 2-8°C and 20-25°C. |
| Viral Recovery: Change of virus titer within one log (+/-90%) from the baseline (time point 0) considered acceptable for H1N1, Adenovirus, and RSV. | Met: The Azer Scientific Universal Transport Medium demonstrated the recovery of H1N1 Influenza BEI NR-29027, Adenovirus 10 JJ, and Human Respiratory Syncytial Virus (HRSV) in all replicates at tested incubation times (24 and 48 hours) and storage conditions (2-8°C and 20-25°C) met the acceptance criteria. For example, for Influenza A, the average percent change at 48 hours was 77% at 2-8°C and 41% at 20-25°C, well within the 90% threshold. One instance for Influenza A at 24 hours at 2-8°C showed a 133% increase but was considered acceptable as the subsequent 48hr time point showed ≤ 90% increase, demonstrating stability. Other viral strains also showed results within the acceptance criteria. |
| Sterility for Swabs: Individually packaged and sterile. | Met: The swabs provided with the Azer Scientific Universal Transport Medium are individually packaged and are sold as sterile. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Description: The performance testing for viral recovery involved "three (3) lots of test kits." Each viral strain (Influenza A, Adenovirus, RSV) was spiked into "pooled, human nasopharyngeal swab sample matrix tested as negative using an FDA cleared RT-PCR assay." Serial dilutions (10⁻¹, 10⁻², 10⁻³, and 10⁻⁴) of each virus were used, and samples were tested "in triplicate."
- Sample Size Calculation (Implied): While an explicit sample size calculation is not provided, the "in triplicate" testing for each dilution, across 3 lots, for 3 viruses, at 2 temperatures, and 3 time points (0, 24, 48 hours) suggests a robust experimental design.
- Data Provenance: The origin of the "pooled, human nasopharyngeal swab sample matrix" is not explicitly stated (e.g., country of origin). The study appears to be a prospective laboratory study designed to evaluate the viral transport medium's performance under controlled conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/ML device relying on expert-reviewed imagery or clinical interpretation. The ground truth for viral recovery studies is established by laboratory methods, specifically:
- Inoculation of known viral strains at specific concentrations.
- Measurement of viral titers (TCID50/mL) using established cell culture techniques.
- Observation of cytopathic effect (CPE) under a microscope, which is a standard laboratory endpoint.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device where human interpretation or consensus is required for establishing ground truth from complex data. The evaluation relies on quantitative laboratory measurements of viral titers and qualitative observations of cell culture effects.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device. The device itself is the transport medium, and its performance is evaluated in a standalone manner without human-in-the-loop assistance for its primary function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance study (viral recovery) was established by:
- Known Viral Stocks: Using well-characterized and quantified viral strains (Influenza A, Adenovirus, HRSV).
- Laboratory Assays: Measuring viral viability and infectivity through cell culture techniques (cytopathic effect - CPE) and calculating viral titers (TCID50/mL) using the Reed-Muench method. This is a scientific, quantitative ground truth.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device requiring a training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 11, 2024
C/O Katrina Fiedler Founder & Principal Consultant WolfKat Regulatory Consulting, LLC. 44 Oxford Drive East Winsor, New Jersey 08520
Re: K202531
Trade/Device Name: Azer Scientific Universal Transport Medium Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: Class I. reserved Product Code: JSM Dated: August 31, 2020 Received: September 1, 2020
Dear Katrina Fiedler:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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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,
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 Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K202531
Device Name
Azer Scientific Universal Transport Medium
Indications for Use (Describe)
The Azer Scientific Universal Transport Medium is for the collection and transport of upper respiratory clinical specimens. containing respiratory viruses from the to the testing laboratory. The Azer Scientific Universal Transport Medium is a culture-based media that can be processed usincal laboratory operating procedures for the isolation and detection of upper respiratory viruses including Influenza A, Respiratory Syncytial Virus (RSV) and Adenovirus.
| 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 - K202531
April 10, 2024
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
| Submitted by: | Azer Scientific, Inc. | |
|---|---|---|
| 701 Hemlock Road | ||
| Morgantown PA 19543 | ||
| Tel: +1-610-524-5810 | ||
| E-mail: info@AzerSci.com | ||
| Website: www. AzerSci.com | ||
| Contact Person: | Katrina Fiedler, | |
| Founder and Principal Consultant, | ||
| WolfKat Regulatory Consulting, LLC. | ||
| 44 Oxford Drive | ||
| East Winsor, NJ 08520 | ||
| Tel: +1-609-902-6162 | ||
| Email: admin@wolfkatreg.com | ||
| Website: www.wolfkatreg.com | ||
| Name of Device: | Azer Scientific Universal Transport Medium | |
| Classification Name: | Culture Media, Non-Propagating Transport | |
| Regulatory Class: | Class I | |
| Product Code: | JSM | |
| Regulation: | 21 CFR 866.2390 | |
| Predicate Device: | Copan Universal Transport Medium (UTM-RT) System | |
| (K042970) Manufacturer: Copan Diagnostics Inc. |
1. Intended Use/Indication for Use
The Azer Scientific Universal Transport Medium is for the collection and transport of upper respiratory clinical specimens, containing respiratory viruses from the collection site to the testing laboratory. The Azer Scientific Universal Transport Medium is a culture-based media that can be processed using standard clinical laboratory operating procedures for the isolation and detection of upper respiratory viruses including Influenza A, Respiratory Syncytial Virus (RSV) and Adenovirus.
2. Device Description
The Azer Scientific Universal Transport Medium includes a plastic screw-cap tube with conical bottom containing 3 mL of transport medium and three, 3 mm size glass beads. Azer Scientific Universal Transport Medium tubes can be supplied alone or in a kit format with one of three different collection swab options in a sterile peel pouch.
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Swab Options:
- PurFlock Ultra 6" Sterile Standard Flock Swab w/Polystyrene Handle, 80mm Breakpoint. ● Regular Flock Tipped Specimen Collection Applicator and Plastic Handle (80mm Breakpoint) (SKU#: 25-3306-U).
- PurFlock Ultra 6" Sterile Revised Ultrafine Flock Swab w/Polystyrene Handle, 80mm . Breakpoint. Revised Ultrafine Flock Tipped Applicator with Plastic Handle (80mm breakpoint) (SKU#: 25-3320-U EMB 80MM)
- Azer Scientific 3" Foam Swab, individually wrapped, sterile (ES45019S) .
| PRODUCT DESCRIPTION | |||
|---|---|---|---|
| SKU | TUBE | SWAB | PACKAGING |
| PFUTM-10 | 3 mL universal transportmedium in 10mL screwcap tube with internalshaped conical bottomwith 3 mm size glassbeads | NA | 50/Pack |
| PFUTM-15 | 3 mL universal transportmedium in 15mL screwcap tube with internalshaped conical bottomwith 3 mm size glassbeads | NA | 50/Pack |
| ES45019S | NA | Azer Scientific FoamSwab, individuallywrapped, sterile | 500/pack |
| NPKIT-10 | PFUTM-10 | PurFlock Ultra 6" SterileRevised Ultrafine FlockSwab w/PolystyreneHandle, 80mmBreakpoint. RevisedUltrafine Flock TippedApplicator with PlasticHandle (80mmbreakpoint) | 50/pack |
| MCKIT-10 | PFUTM-10 | PurFlock Ultra 6" SterileStandard Flock Swabw/Polystyrene Handle,80mm Breakpoint.Regular Flock TippedSpecimen CollectionApplicator and PlasticHandle(80mm Breakpoint) | 50/pack |
| FOAMKIT-10 | PFUTM-10 | 3" Foam SpecimenCollection Swab | 50/pack |
| NPKIT-15 | PFUTM-15 | PurFlock Ultra 6" SterileRevised Ultrafine FlockSwab w/PolystyreneHandle, 80mmBreakpoint. RevisedUltrafine Flock TippedApplicator with PlasticHandle (80mmbreakpoint) | 50/pack |
| MCKIT-15 | PFUTM-15 | PurFlock Ultra 6" SterileStandard Flock Swabw/Polystyrene Handle,80mm Breakpoint.Regular Flock TippedSpecimen CollectionApplicator and PlasticHandle (80mmBreakpoint) | 50/pack |
| FOAMKIT - 15 | PFUTM-15 | 3" Foam Specimencollection Swab | 50/pack |
The Azer Scientific Universal Transport Medium is offered in the following configurations:
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Media Formulation:
- Hank's Balanced Salt Solution ●
- Bovine Serum Albumin ●
- L-cysteine ●
- Gelatin
- Sucrose ●
- L-glutamic acid ●
- HEPES buffer
- Vancomycin
- Amphotericin B ●
- . Colistin
- Phenol red ●
3. Principles of Operation
The Azer Scientific Universal Transport Medium is an isotonic and non-toxic medium. The medium consists of the following: Hank's Balanced Salt Solution. Bovine Serum Albumin, Lcysteine, L-glutamic acid, Vancomycin, Amphotericin B, Colistin, gelatin, HEPES Buffer, sucrose and Phenol red. The Hank's buffer creates a neutral environment to help increase the stability of the virus. Bovine Serum Albumin (BSA) acts as a protein stabilizer by 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. Vancomycin, Amphotericin B, and Colistin inhibit the proliferation of competing bacteria and yeasts. 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. Phenol red is
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a pH indicator which serves as a visual quality control mechanism. The L-cysteine, gelatin, and sucrose, helps in preserving the virus.
4. Substantial Equivalence
The Azer Scientific Universal Transport Medium 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 Azer Scientific Universal Transport Medium is adequately supported by the substantial equivalence information and testing results provided. Below is a summary of comparison table between Azer Scientific Universal Transport Medium and the predicate device, K042970:
| Device & PredicateDevice(s): | Device: K202531 | Predicate: K042970 |
|---|---|---|
| Device Trade Name | Azer Scientific UniversalTransport Medium | Copan Universal TransportMedium (UTM-RT) System |
| General DeviceCharacteristicSimilarities | ||
| Intended Use/Indicationsfor Use | The Azer Scientific UniversalTransport Medium is for thecollection and transport ofupper respiratory clinicalspecimens, containingrespiratory viruses from thecollection site to the testinglaboratory. The Azer ScientificUniversal Transport Mediumis a culture-based media thatcan be processed usingstandard clinical laboratoryoperating procedures for theisolation and detection ofupper respiratory virusesincluding Influenza A,Respiratory Syncytial Virus(RSV) and Adenovirus. | Copan Universal TransportMedium (UTM-RT) System isintended for the collection andtransport of clinical specimenscontaining viruses,chlamydiae, mycoplasma orureaplasma from the collectionsite to the testing laboratory.UTM-RT can be processedusing standard clinicallaboratory operatingprocedures for viral,chlamydial, mycoplasma andureaplasma culture. |
| Single-use Device | Yes | Same |
| Medium Formulation | Hank's Balanced Salt SolutionBovine Serum AlbuminL-cysteineGelatinSucroseL-glutamic acidHEPES bufferVancomycinAmphotericin BColistinPhenol red | Same |
| pH | 7.3 ± 0.2 | Same |
| Storage Temperature | 2 - 25°C | Same |
| Glass Beads | 3 x 3 mm | Same |
| Container | Plastic, conical bottom | Same |
| Product Configuration | Media in tube with cap orMedia Kit; Media in tube withcap and sterile swab options | Same |
| Shelf Life | 12 months | Same |
| General DeviceCharacteristicDifferences | ||
| Fill volume | 3 mL | 1.5 mL; 3 mL; or 10 mL |
| Swab Tip | Flocked Nylon (SpecimenCollection and NP Swabs)Reticulated PolyurethaneFoam (Mid-turbinate FoamSwab) | Polyester |
| Swab Shaft | Polypropylene (SpecimenCollection, NP, and FoamSwabs) | Plastic; Stainless Steel - Plastic |
| Viruses: | Viruses: | |
| Supported Strains | Influenza AAdenovirusRespiratory Syncytial Virus(RSV) | AdenovirusCytomegalovirus (CMV)Echovirus Type 30 (Echo 30)Herpes Simplex Virus Type 1(HSV1)HSV2Influenza AParainfluenza Type 3Respiratory Syncytial Virus(RSV)Varicella Zoster Virus (VZV)Chlamydiae:Chlamydia pneumoniae StrainCM-1Chlamydia trachomatis Type 1Strain UW-12/URMycoplasma:Mycoplasma hominisMycoplasma pneumoniaeUreaplasma:Ureaplasma urealyticum |
| Sample Stability | 48 hrs. at 2-8°C or 20-25°C |
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5. Shelf-life Stability
The shelf-life of the Azer Scientific Universal Transport Medium was determined to be 12 months from the date of manufacture when stored at 2-25°C. Three lots of Azer Scientific Universal Transport Medium were assessed qualitatively at each time point for functionality and physical characteristics using real time ageing studies. In the real time study, media lots were held at 2-8°C, and 20-25°C for 12 months (T=0, 3, 6, 9, and 12 months).
-
a) Appearance
To evaluate appearance, the different lots of the Azer Scientific Universal Transport Medium were visually examined. The appearance of the product was observed to have no significant color change (pink, transparent), precipitate, particulates, or cloudy appearance. All lots tested at each time point passed the criteria for appearance when held at 2-8°C, and 20-25°C. -
b) 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 each lot, the pH was within the targeted range of 7.3±0.2 when held at 2-8°C and 20-25°C only.
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- c) Microbial contamination check
- Microbial contamination was determined by incubating an appropriate number of Azer Scientific Universal Transport Medium lots overnight at 37±2°C and examined for growth contaminants. All lots tested at each time point and each temperature passed the criteria for no contamination (no growth) when held at 2-8°C, and 20-25°C.
6. Sterility
The Azer Scientific Universal Transport Medium is not claimed to be sterile nor is it intended to be sterilized by the end user. To decrease the chances of contamination, components of the Azer Scientific Universal Transport Medium are either sterilized by moist heat sterilization or filter sterilization and the transport medium is filled aseptically under controlled conditions. The swabs provided with the Azer Scientific Universal Transport Medium are individually packaged and are sold as sterile.
7. Performance Data
Performance Testing - Viral Recovery:
Performance of the Azer Scientific Universal Transport Medium was evaluated by performing culture-based recovery studies. The viral recovery study was conducted by spiking virus stock Influenza A/Puerto Rico-8-9VMC2/1934 (H1N1), Human Adenovirus 10 JJ (AV), and Human Respiratory Syncytial Virus, Strain A1998/3-2 (HRSV) into pooled, human nasopharyngeal swab sample matrix tested as negative using an FDA cleared RT-PCR assay.
Performance evaluation was carried out using three (3) lots of test kits each including a PurFlock Ultra 6" Sterile Revised Ultrafine Flock Swab w/Polystyrene Handle, 80 mm Breakpoint swab provided with Azer Scientific Universal Transport Medium with serial dilutions of each virus (10-), 10-2, 10-3 and 10-4) spiked into negative clinical matrix in triplicate. Contrived samples were held at both 2-8°C and 20-25°C for 0, 24, and 48 hours in a 96-well plate.
Samples in the 96-well plate were examined under the microscope for cytopathic effect (CPE) after the appropriate incubation period for each virus time point. Viral titers of samples collected at 0. 24. and 48 hours were calculated for recovery and determined by percent log reduction of TCID50/mL using the Reed-Muench method. Host cell lines used for the different viruses are outlined in Table 1. Viral Recovery study data is outlined in Table 2. Any change of virus titer that was within one log (+/-90%) from the baseline (time point 0) was considered acceptable.
| Organism | Strain ID | Host Cell/GrowthMedium |
|---|---|---|
| Influenza A/Puerto Rico-8-9VMC2/1934(H1N1) | NR-29027 | MDCK cells/EMEM +10% FBS |
| Human Adenovirus 10 JJ (AV) | NR-53907 | A549 cells/EMEM + 10%FBS |
| Human Respiratory Syncytial Virus, StrainA1998/3-2 (HRSV) | NR-28529 | HEP-2 cells/EMEM +10% FBS |
Table 1: Host Cells
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| Duration(hrs.) | 2-8°C | 20-25°C | |||
|---|---|---|---|---|---|
| Viral Strain | AverageTCID50/mL | AveragePercentChange(- is areduction) | AverageTCID50/mL | AveragePercentChange(- is areduction) | |
| InfluenzaA/PuertoRico-8-9VMC2/1934(H1N1) | 0 | 4.74 x 103 | N/A | 4.74 x 103 | N/A |
| 24 | 11.03 x 103 | 133%* | 8.76 x 103 | 85% | |
| 48 | 8.38 x 103 | 77% | 6.69 x 103 | 41% | |
| Adenovirus 10JJ (AV) | 0 | 22.43 x 103 | N/A | 22.43 x 103 | N/A |
| 24 | 14.30 x 103 | -36% | 39.47 x 103 | 76% | |
| 48 | 9.53 x 103 | -58% | 13.94 x 103 | -38% | |
| HumanRespiratorySyncytialVirus (HRSV) | 0 | 16.48 x 103 | N/A | 16.48 x 103 | N/A |
| 24 | 10.01 x 103 | -39% | 15.50 x 103 | -6% | |
| 48 | 16.47 x 103 | -0% | 12.63 x 103 | -23% |
- Considered acceptable because subsequent timepoint, i.e., 48 h time points showed ≤ 90% increase.
Conclusion of the culture-based viral recovery study:
The Azer Scientific Universal Transport Medium demonstrated the recovery of H1N1 Influenza BEI NR-29027, Adenovirus 10 JJ, and Human Respiratory Syncytial Virus (HRSV) in all replicates at tested incubation times and storage conditions met the acceptance criteria. This data supports the transportation of Influenza A, Adenovirus, and Respiratory Syncytial Virus (RSV) in Azer Scientific Universal Transport Medium when stored refrigerated (2-8°C) or room temperature (20-25°C) for up to 48 hours.
8. Conclusion
Based on the indications for use, technological characteristics, safety, and performance testing, the subject device, Azer Scientific Universal Transport Medium 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.
§ 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).