BioSci™ Disposable Virus Sampling Tubes

{0} FDA U.S. FOOD & DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY ## I Background Information: A 510(k) Number K230035 B Applicant Shenzhen Dakewe Bio-engineering Co., Ltd. C Proprietary and Established Names BioSci Disposable Virus Sampling Tubes D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | JSM | Class I, reserved | 21 CFR 866.2390 - Transport Culture Medium | MI - Microbiology | ## II Submission/Device Overview: A Purpose for Submission: To obtain a substantial equivalence determination for the BioSci Disposable Virus Sampling Tube for the collection and transport of clinical specimens containing viruses or chlamydiae from the collection site to the testing laboratory. B Measurand: Not applicable. C Type of Test: Non-propagating Transport Device. ## III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} K230035 - Page 2 of 8 B Indication(s) for Use: BioSci Disposable Virus Sampling Tube is intended for the collection and transport of clinical specimens containing viruses or chlamydiae from the collection site to the testing laboratory. The system can be processed using standard clinical laboratory operating procedures for culture of clinical specimens. C Special Conditions for Use Statement(s): Rx - For Prescription Use Only D Special Instrument Requirements: IV Device/System Characteristics: A Device Description: BioSci Disposable Virus Sampling Tube includes a screw-cap tube containing transport medium which is divided into two formats – in kit and tube. The format in kit is supplied in pre-packaged collection sets containing one of the two swab types: 1. Minitip (2.5 mm tip) flocking swab with 8 cm breaking point, for nasopharyngeal specimen collection 2. Regular (5 mm tip) flocking swab with 3 cm breaking point, for oropharyngeal specimen collection The screw-cap tube in kit format is pre-filled with 1 or 3 mL of transport medium for safe transportation of biological specimen. The format in tube only contains labeled screw-cap tubes pre-filled with 1 mL, 1.5 mL, 2 mL, and 3 mL of transport medium. The different configurations of BioSci Disposable Virus Sampling Tube are provided in table 1. Table 1. BioSci Disposable Virus Sampling Tube has following configurations: | REF | Model | Description | | | --- | --- | --- | --- | | | | Volume | Swab | | 6991111 | VN | 1 mL | One minitip flocking swab with 8 cm breaking point | | 6991311 | | 3 mL | | | 6991121 | VO | 1 mL | One regular flocking swab with 3 cm breaking point | | 6991321 | | 3 mL | | | 6991191 | VNO | 1 mL | One minitip flocking swab with 8 cm breaking point and one regular flocking swab with 3 cm breaking point | | 6991391 | | 3 mL | | | 6991034 | VM | 1 mL | Swab not included | | 6991074 | | 1.5 mL | | | 6991024 | | 2 mL | | | 6991014 | | 3 mL | | {2} K230035 - Page 3 of 8 ## B Principle of Operation: The BioSci Disposable Virus Sampling Tube is used to safely collect and transport of clinical specimens containing viruses or chlamydiae from collection sites to the testing laboratories. The transport media is packaged alone or with one of two swabs. Swabs are comprised of a solid molded plastic applicator shaft and the tip of the applicator is flocked and either a regular (5 mm) tip or a mini (2.5 mm) tip. After collecting specimens using the swab, the swab is put into the preservation tube for storage and transportation, and subsequent testing. Sample collection is intended to be used by health care professionals. The BioSci Disposable Virus Sampling Tube medium is composed of Hank's balanced salt solution, bovine serum albumin, glucose and the pH are buffered with HEPES buffer. Phenol red is used to indicate pH. Gentamicin and amphotericin B are incorporated into the medium to inhibit competing bacteria and fungi. The medium is isotonic and has been shown to be non-toxic to mammalian host cells. ## V Substantial Equivalence Information: ### A Predicate Device Name(s): Copan Universal Transport Medium (utm-rt) System ### B Predicate 510(k) Number(s): K042970 ### C Comparison with Predicate(s): | Device & Predicate Device(s): | Device: K230035 | Predicate: K042970 | | --- | --- | --- | | Device Trade Name | BioSci Disposable Virus Sampling Tube | Copan Universal Transport Medium (UTM-RT) System | | General Device Characteristic Similarities | | | | Intended Use/Indications For Use | BioSci Disposable Virus Sampling Tube is intended for the collection and transport of clinical specimens containing viruses or chlamydiae from the collection site to the testing laboratory. The system can be processed using standard clinical laboratory operating procedures for culture of clinical specimens. | 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. | | Single Use Device | Yes | Same | | Product Configuration | Medium Tubes; Kit with Medium Tubes and | Same | {3} | | Swab Options | | | --- | --- | --- | | pH | 7.3 ± 0.2 | Same | | Storage Temperature | 2 - 25°C | Same | | General Device Characteristic Differences | | | | Medium Formulation | Hank’s Balanced Salt Solution Bovine Serum Albumin Glucose HEPES buffer Amphotericin B Gentamicin Phenol red | Hank’s Balanced Salt Solution Bovine Serum Albumin Gelatin Sucrose L-glutamic acid HEPES buffer Vancomycin Amphotericin B Colistin Phenol red L-cysteine | | 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 | • 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 pneumoniae • Ureaplasma urealyticum • Mycoplasma hominis | | Medium Volume | 1 mL; 1.5 mL; 2 mL; or 3 mL; | 1.5 ml; 3 ml; or 10 ml | | Container | Tube; plastic; self-standing with a screw cap | Tube; plastic; self-standing with a screw cap; with three 3mm glass beads | | Shelf-life | 18 months | 12 months | VI Standards/Guidance Documents Referenced: Not applicable. VII Performance Characteristics (if/when applicable): A Analytical Performance: 1. Precision/Reproducibility: Not applicable. K230035 - Page 4 of 8 {4} 2. Linearity: Not applicable. 3. Analytical Specificity/Interference: Not applicable. 4. Assay Reportable Range: Not applicable. 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods): Shelf-life Stability: The shelf life for the BioSci Disposable Virus Sampling Tube was determined to be 18 months from the date of manufacture when stored at temperature $2 - 25^{\circ}\mathrm{C}$. The shelf life of the BioSci Disposable Virus Sampling Tube was established using real-time aging performance test at time points $\mathrm{T} = 0, 3, 6, 9, 12, 15$ and 18 months. Three lots of the BioSci Disposable Virus Sampling Tube were evaluated for appearance, net content, pH value, bacteriostasis, sterility and recovery study at each time point in the real-time aging performance test. a. Shelf-Life, Appearance, Net content, and pH Value: The shelf-life stability was conducted by visual inspection with the following criteria: the package should be intact without damage and no leakage of liquid; the media should appear to be a red and transparent without any color change, turbidity, or obvious precipitation. All lots tested at each time point passed the criteria for appearance. Net content stability was evaluated by measuring the volume of transport medium. The net content should not be less than the labeled volume. All the tubes tested in time points (1, 3, 9, 12, 15, and 18 months) meet the criteria for volume content. The pH stability of the transport medium was determined through testing of five replicates from each lot at each of the following time points (1, 3, 9, 12, 15, and 18 months). For all the tubes at each time point, the pH was within the predefined pH range of $7.3 \pm 0.3$. b. Sterility: The BioSci Disposable Virus Sampling Tube is not claimed to be sterile nor is it intended to be sterilized by the end user. To decrease the chances of contamination the screw-cap tubes are sterilized by e-beam irradiation and the transport medium is filled aseptically under control conditions. The results for appearance, net content, and pH value, collectively support the claim for 18 months of storage for the BioSci Disposable Virus Sampling Tube at $2 - 25^{\circ}\mathrm{C}$. 6. Detection Limit: Performance Testing - Recovery Studies: K230035 - Page 5 of 8 {5} Performance of the BioSci Disposable Virus Sampling Tube was evaluated by Culture-Based Recovery Studies for viruses and chlamydiae. For Viral Recovery Studies, Fluorescent Foci Count method was utilized to evaluate the recovery of Adenovirus (ATCC VR-1), Cytomegalovirus (ATCC VR-977), Herpes Simplex Virus Type 1 (ATCC VR-260) and Influenza A (ATCC VR-1736). This method was also utilized to evaluate the recovery of Chlamydia pneumoniae (ATCC VR-1360). Performance evaluation was carried out in four lots of media that represent newly manufactured media and older media (about to expire or recently expired). Virus stocks were diluted into two different dilutions in pooled negative clinical matrix and each dilution was inoculated into swab in triplicate and placed into BioSci Disposable Virus Sampling Tube to store at 2 - 8°C and 20 - 25°C for 0 and 48 hours respectively. At each time point following inoculation, each sample was vortexed, and an aliquot was taken for recovery study using suitable tissue culture medium and host cells. For tissue culture, host cells were seeded in a 96-well plate and allowed to adhere for 24 - 48 hours. MRC-5 cells (SCSP-5040) were used for Adenovirus and Cytomegalovirus, Vero cells (GNO10) for Herpes Simplex Virus Type 1, and MDCK cells (GNO23) for Influenza A. Aliquot of 100 microliter (μL) virus suspensions prepared in gradient dilutions in triplicate were added on the monolayer plate. After incubation, specific immunofluorescent antibody staining was used for detection. For Chlamydia recovery, McCoy cells (ATCC CRL-1696) were used. The number of infectious particles were counted as Fluorescent Foci and average recovery was calculated as mean of foci count per inoculum volume into 96-well plate (0.05 mL) for each storage temperature and time points. The changes (any increase or decrease) in the recovery between timepoints (0 to 48 hr) were presented in percent values (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 the Table 2 and 3. Table 2. Recovery of viruses and Chlamydiae at 4°C storage. | Test Strain | Average Recovery in Foci count/mL (×104Foci Counts/mL) | | Changes in 0 - 48 hrs. (-ve indicates reduction) | | --- | --- | --- | --- | | | 0 hr. | 48 hrs. | | | Adenovirus | 1.75 | 2.39 | 36% | | Cytomegalovirus | 1.65 | 1.46 | -12% | | Herpes Simplex Virus Type 1 | 1.33 | 1.56 | 17% | | Influenza A | 14.87 | 4.13 | -72% | | Chlamydia pneumoniae | 15.94 | 14.75 | -7% | Table 3. Recovery of viruses and Chlamydiae at 25°C storage. | Test Strain | Average Recovery in Foci count/mL (×104Foci Counts/mL) | | Changes in 0 - 48 hrs. (-ve indicates reduction) | | --- | --- | --- | --- | | | 0 hr. | 48 hrs. | | | Adenovirus | 1.75 | 2.58 | 47% | | Cytomegalovirus | 1.65 | 0.70 | -57% | | Herpes Simplex Virus Type 1 | 1.33 | 1.59 | 20% | | Influenza A | 14.87 | 1.44 | -90% | K230035 - Page 6 of 8 {6} K230035 - Page 7 of 8 | Chlamydia pneumoniae | 15.94 | 13.08 | -18% | | --- | --- | --- | --- | Conclusion: The BioSci Disposable Virus Sampling Tube demonstrated the recovery of tested viruses at an acceptable rate (Adenovirus, Cytomegalovirus, HSV Type 1 and Influenza A), and Chlamydia pneumoniae at 4°C and 25°C up to 48 hours. Based on these results, the following statement was added to the package insert. - Better recovery of viruses and chlamydiae are achieved when specimens are processed shortly after the time of collection and within 48 hours of collection when transported at 4°C compared to 25°C. 7. Assay Cut-Off: Not Applicable. B Comparison Studies: 1. Method Comparison with Predicate Device: Not Applicable. 2. Matrix Comparison: Not Applicable. C Clinical Studies: 1. Clinical Sensitivity: Not Applicable. 2. Clinical Specificity: Not Applicable. 3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable): Not Applicable. D Clinical Cut-Off: Not Applicable. E Expected Values/Reference Range: Not Applicable. {7} VIII Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. IX Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. K230035 - Page 8 of 8