(433 days)
The Dasky Disposable Sampling Tube (Model name: VSM02) is intended for the stabilization, transportation and inactivation of infectious unprocessed nasopharyngeal specimen samples suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens from the collection site to the laboratory. The specimens collected and stored in a Dasky Disposable Sampling Tube (Model name: VSM02) are suitable for use with compatible laboratory based molecular diagnostic devices.
The Dasky Disposable Sampling Tube (Model name: VSM02) consists of a plastic transport tube with medium which is supplied alone or in a kit with a nasopharyngeal (NP) swab, and an optional biosafety bag. The plastic transport tube contains 3 mL of the stabilization media. The media are intended to inactivate SARS-CoV-2 virus, lyse the cells, disruptlyse the lipid membranes and denature proteins for storage of the specimen between 39 °F and 73 °F (4°C - 23°C). The media is sold in the following configurations.
- . A plastic screw-cap tube filled with 3 mL of Dasky Disposable Sampling Tube media.
- . A plastic screw-cap tube filled with 3 mL of Dasky Disposable Sampling Tube media and a NP nylon flocked swab for sample collection.
This response is based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Limit of Detection (LoD) | SARS-CoV-2 RNA could be repeatedly recovered with an accuracy >95% | At 70 GCE/mL, 60/60 replicates were positive for all three lots (100% detection). At 63 GCE/mL, 47/60 replicates were positive (78% detection). The report states that the LoD at 70 GCE/mL meets the pre-defined acceptance criteria for NP swabs. |
| Specimen Stability (Ambient) | Acceptable RNA stabilization; deviation in Ct values < 2 compared to T₀ | At 23°C for at least 48 hours, the deviation between initial Ct and stored Ct was less than 2 Ct for ORF1ab, N gene, and S gene across all three lots and replicates. All replicates remained positive (100%). |
| Specimen Stability (Refrigerated) | Acceptable RNA stabilization; deviation in Ct values < 2 compared to T₀ | At 4°C for at least 144 hours, the deviation between initial Ct and stored Ct was less than 2 Ct for ORF1ab, N gene, and S gene across all three lots and replicates. All replicates remained positive (100%). |
| Inactivation | 100% inactivation of SARS-CoV-2 virus | For SARS-CoV-2 virus at 1x 10³ GCE/mL, 100% inactivation was observed at a minimum of 5 minutes in the Dasky Disposable Sampling Tube for all three lots. The experimental group showed uninfected Vero-E6 cells, while the control group showed infected cells. |
| Shelf-life | Stability maintained for 1 year post-manufacture (based on appearance, pH, RT-PCR, inactivation efficiency, and LoD) | Real-time stability study on 9 samples (3 lots) showed acceptable performance for item appearance, pH detection, RT-PCR test, virus inactivation efficiency, and Limit of detection. The device is confirmed to have a shelf-life of 1 year. This is implicitly stated as meeting the requirement by the conclusion that the device performs as well as or better than the predicate. |
2. Sample Size Used for the Test Set and the Data Provenance
- LoD Testing: 60 replicates per concentration level (20 tubes/lot * 3 lots) for a total of 300 replicates across the tested concentrations from 63 GCE/mL to 10^4 GCE/mL.
- Data Provenance: Clinical NP swab specimens collected from healthy individuals who tested negative for SARS-CoV-2 virus. (Country of origin not specified, but the applicant company is based in China.) The study is prospective in the sense that the test samples were prepared and evaluated, but the origin of the base clinical NP swab specimens is retrospective in their collection.
- Specimen Stability: 3 replicates per lot for each storage condition (T₀, T₂₃->₄₈, T₄->₁₄₄) across 3 lots, for a total of 27 samples tested in the stability study (9 per lot * 3 time points).
- Data Provenance: Clinical NP swab specimens collected from individuals who tested negative for SARS-CoV-2 virus. (Country of origin not specified, but the applicant company is based in China.)
- Inactivation: 3 experimental samples per lot and 1 control sample per lot across 3 lots.
- Data Provenance: Clinical NP swab specimens collected from 9 healthy individuals who tested negative for SARS-CoV-2 virus (for the experimental group). The virus itself was spiked. (Country of origin not specified, but the applicant company is based in China.)
- Shelf-life: 9 samples (3 lots)
- Data Provenance: Not explicitly detailed beyond being "Realtime stability study" using manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not specify the use of experts to establish ground truth for the test set.
- For LoD and Specimen Stability, ground truth was established by spiking known concentrations/titers of SARS-CoV-2 virus into negative clinical NP swab specimens and then evaluating its detection by RT-PCR.
- For Inactivation, ground truth was established by observing cytological changes in Vero-E6 cells after exposure to the treated virus, comparing experimental (inactivated) to control (non-inactivated) samples.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving experts for any of the test sets. The determination of positive/negative and Ct values for LoD and stability was quantitative via RT-PCR. Inactivation was determined by observing cell morphology under an electron microscope, comparing treated samples to controls.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a microbial nucleic acid storage and stabilization device, not an imaging or diagnostic device that typically involves human readers. The performance studies evaluate the device's ability to preserve and inactivate the virus, assayed by laboratory methods.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone performance evaluations of the device (Dasky Disposable Sampling Tube (Model name: VSM02)) itself, without a human-in-the-loop component in terms of interpretive performance. The device's function is to stabilize, transport, and inactivate samples, not to
diagnose or interpret.
7. The Type of Ground Truth Used
- For LoD and Specimen Stability: Spiked samples with known concentrations/titers of SARS-CoV-2 virus into clinical NP swab specimens confirmed to be negative for SARS-CoV-2. This combines a known viral load (synthetic representation of infection) with clinical matrix. Detection was via RT-PCR, providing a quantitative ground truth (Ct values).
- For Inactivation: Live SARS-CoV-2 virus spiked into negative clinical NP swab specimens, followed by incubation in the device medium or control (PBS). The ground truth for inactivation was determined by measuring the ability of the treated samples to infect Vero-E6 cells, which is a direct measure of viral viability/infectivity (viability/infection outcome data).
8. The Sample Size for the Training Set
The document does not describe a training set. This is a medical device for sample collection and stabilization, not an AI or machine learning algorithm that typically requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is described for this device.
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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 & 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.
Ningbo Dasky Life Science Co., Ltd. Wilson Wong Sales Manager No. 6, Donggong 1st Road, Yinzhou District Ningbo, Zhejiang 315000 China
August 8, 2022
Re: K211675
Trade/Device Name: Dasky Disposable Sampling Tube (Model name: VSM02) Regulation Number: 21 CFR 866.2950 Regulation Name: Microbial nucleic acid storage and stabilization device Regulatory Class: Class II Product Code: QBD Dated: May 25, 2021 Received: June 1, 2021
Dear Wilson Wong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
Kristian Roth, Ph.D. Deputy Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211675
Device Name
Dasky Disposable Sampling Tube (Model name: VSM02)
Indications for Use (Describe)
The Dasky Disposable Sampling Tube (Model name: VSM02) is intended for the stabilization, transportation and inactivation of infectious unprocessed nasopharyngeal specimen samples suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens from the collection site to the laboratory. The specimens collected and stored in a Dasky Disposable Sampling Tube (Model name: VSM02) are suitable for use with compatible laboratory based molecular diagnostic devices.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: August 7,2022
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | NINGBO DASKY LIFE SCIENCE CO.,LTD. |
|---|---|
| Address: | No.6, Donggong 1st Road, Yinzhou District,Ningbo, Zhejiang315000 China |
| Contact person: | Wilson Wong |
| Title: | Sales manager |
| E-mail: | sales@daskymed.com |
| Tel: | +86-13566546046 |
2. Device Identification
| 510(K) number: | K211675 |
|---|---|
| Trade/Device Name: | Dasky Disposable Sampling Tube (Model name: VSM02) |
| Models: | VSM02 |
| Regulation Number: | 21 CFR 866.2950 |
| Regulation Description: | Microbial Nucleic Acid Storage And Stabilization Device |
| Regulation Class: | Class II |
| Panel: | Microbiology |
| Product Code: | QBD |
3. Predicate Device
| 510(K) number: | K202641 |
|---|---|
| Device Name: | DNA/RNA Shield Collection tube |
| Manufacturer: | Zymo Research |
| Regulation Description: | Microbial Nucleic Acid Storage And Stabilization Device |
| Regulation Number: | 21 CFR 866.2950 |
| Regulation Class: | Class II |
| Panel: | Microbiology |
| Product Code: | QBD |
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4. Device Description
The Dasky Disposable Sampling Tube (Model name: VSM02) consists of a plastic transport tube with medium which is supplied alone or in a kit with a nasopharyngeal (NP) swab, and an optional biosafety bag. The plastic transport tube contains 3 mL of the stabilization media. The media are intended to inactivate SARS-CoV-2 virus, lyse the cells, disruptlyse the lipid membranes and denature proteins for storage of the specimen between 39 °F and 73 °F (4°C - 23°C). The media is sold in the following configurations.
- . A plastic screw-cap tube filled with 3 mL of Dasky Disposable Sampling Tube media.
- . A plastic screw-cap tube filled with 3 mL of Dasky Disposable Sampling Tube media and a NP nylon flocked swab for sample collection.
5. Indication for use
The Dasky Disposable Sampling Tube (Model name: VSM02) is intended for the stabilization, transportation and inactivation of infectious unprocessed nasopharyngeal specimen samples suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens from the collection site to the laboratory. The specimens collected and stored in a Dasky Disposable Sampling Tube (Model name: VSM02) are suitable for use with compatible laboratory based molecular diagnostic devices.
6. Summary of the technological characteristics of the device compared to the Predicate Device
Compared to the predicate device, the subject device has the similar intended use, product design, and performance as the predicate device, the summarized comparison is listed in following table 1:
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| Device & PredicateDevice(s): | Device: K211675 | Predicate: K202641 |
|---|---|---|
| Device Trade Name | Dasky Disposable Sampling Tube(Model name: VSM02) | DNA/RNA Shield Collection tube |
| General Device Characteristic Similarities | ||
| Intended Use/IndicationsFor Use | The Dasky Disposable SamplingTube (Model name: VSM02) isintended for the stabilization,transportation and inactivation ofinfectious unprocessednasopharyngeal specimensamples suspected of containingSARS-CoV-2. These devices canbe used for collection transportand storage of specimens fromthe collection site to thelaboratory. The specimenscollected and stored in a DaskyDisposable Sampling Tube(Model name: VSM02) aresuitable for use with compatiblelaboratory based moleculardiagnostic devices. | The DNA/RNA Shield collectiontube is intended for thestabilization and inactivation ofupper and lower respiratoryhuman specimens suspected ofcontaining SARS-CoV-2.These devices can be used forcollection transport and storage ofspecimens at ambienttemperatures (20-25°C).Specimens collected and storedin a DNA/RNA Shield collectiontube are suitable for use withlegally marketed moleculardiagnostic devices. |
| Microorganism nucleicacidspreserved | Same | SARS-CoV-2 |
| Container | Same | Tube, plastic, screw cap vials |
| Medium Volume | 3 mL | 1 mL, 2 mL |
| Special conditions foruse | Same | 1. For in vitro diagnostic use only2. For Prescription Use only |
| Sample source | Same | Human respiratory |
| General Device Characteristic Differences | ||
| RNAstabilization atrefrigeration | 144 hours (4°C) | no refrigeration claims |
| RNAstabilizationat ambient temperature | 48 hours (23°C) | 28 days |
| Specimen Type | Nasopharyngeal specimens forSARS-CoV-2. | Lower and Upper RespiratorySpecimens for SARS-CoV-2. |
| Analyte | RNA | RNA and DNA |
| Shelf life | 1 year | 2 years |
Table 1: side by side comparison of subject device and predicate device
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7. Performance Data
1) Limit of detection
The detection limit of SARS-CoV-2 nucleic acid (RNA) in 3 mL media in the Dasky Disposable Sampling Tube (Model name: VSM02) was determined. The detection limit concentration was verified to ensure that SARS-CoV-2 RNA could be repeatedly recovered from the disposable sample tube at the lowest detection concentration with an accuracy greater than 95%. LoD testing was conducted by spiking multiple volume of SARS-CoV-2 virus with a titer of 1x 10° GCE/mL into the clinical NP swab specimen, collected from healthy individuals who tested negative for SARS-CoV-2 virus, and then using the NP swab to transfer the sample into 3 mL of media in the Dasky Disposable Sampling Tube (Model name: VSM02) to achieve final concentrations of 63 GCE/mL, 70 GCE/mL, 102 GCE/mL, 3x 102 GCE/mL 103 GCE/mL, and 104 GCE/mL, for each of the 20 tubes/lot for three lot.
Purified RNA was extracted from 200 µL samples by using MagMAX Viral/Pathogen Nucleic Acid lsolation Kit manufactured by Thermo Fisher Scientific. RT-PCR was performed on the Applied Biosystems 7500 Quantitative Real-time PCR System and TaqPath COVID-19 Combo Kit manufactured by Thermo Fisher Scientific.
~78% detection (viral targets C; values are <37) of the SARS-CoV-2 RNA were observed in samples at 63 GCE/mL (13/60 replicates). The detection of the SARS-CoV-2 RNA at all other higher concentrations: 70 GCE/mL, 102 GCE/mL, 3x 102 GCE/mL, and 104 GCE/mL resulted in 20/20 replicates for each of the three lots (Lot 21060832-02, Lot 21060732-02 and Lot 21061132-02). The LoD testing results are summarized in Table 2:
| GCE/mL | Total # | Positive # | Mean Ct | ||
|---|---|---|---|---|---|
| ORF1ab | N gene | S gene | |||
| 104 | 60 | 60 | 20.94 | 21.08 | 21.04 |
| 103 | 60 | 60 | 24.23 | 23.99 | 24.12 |
| 3x 102 | 60 | 60 | 26.70 | 26.95 | 26.93 |
| 102 | 60 | 60 | 29.95 | 30.04 | 30.29 |
| 70 | 60 | 60 | 32.84 | 32.82 | 33.94 |
| 63 | 60 | 47 | 36.13 | 36.04 | 35.89 |
| Table 2. LoD testing | ||
|---|---|---|
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K211675
In summary, the LoD testing at 70 GCE/mL resulted in 60/60 replicates for NP swabs, which meet the pre-defined acceptance criteria for NP swabs.
2) Specimen Stability
The specimen stability study was conducted by spiking 4.5 µL of SARS-CoV-2 virus at 1x 105 GCE/mL into the clinical NP swab specimen collected from individuals who tested negative for SARS-CoV-2 virus, then using the NP swab to transfer the virus sample into the Dasky Disposable Sampling Tube (Model name: VSM02) containing 3 mL media to achieve the final concentration of the samples at 150 GCE/mL (2.1x LoD).
Three Dasky Disposable Sampling Tube (Model name: VSM02) of each lot (Lot 20100732-01, Lot 21060732-02 and Lot 21121032-01) were tested by RT-PCR and served as To; The measured Cr values for the samples stored at 23°C for at least 48 hours and 4°C for at least 144 hours were defined as T23-48 and T4->144, respectively. Purified RNA was extracted from 200 µL samples by MagMAX Viral/Pathogen Nucleic Acid Isolation Kit manufactured by Thermo Scientific. RT-PCR was performed on the ABI7500 using the EUA-authorized TaqPath COVID-19 Combo kit of Thermo Scientific. The results for the specimen stability study are summarized in Table 3.
| Lot No. | Storage condition | Replicate | Ct | Interpretation | % Positive | ||
|---|---|---|---|---|---|---|---|
| ORF1ab | N gene | S gene | |||||
| 20100732-01 | T₀ | 1 | 28.6 | 28.7 | 28.4 | Positive | 100% |
| 2 | 29.7 | 29.6 | 29.2 | Positive | |||
| 3 | 28.3 | 28.2 | 28.1 | Positive | |||
| T₂₃->₄₈ | 1 | 30.9 | 30.1 | 30.3 | Positive | ||
| 2 | 30.5 | 30.9 | 29.8 | Positive | |||
| 3 | 29.9 | 29.3 | 29.9 | Positive | |||
| T₄->₁₄₄ | 1 | 29.0 | 29.4 | 29.0 | Positive | ||
| 2 | 30.7 | 30.1 | 29.5 | Positive | |||
| 3 | 29.8 | 30.1 | 30.9 | Positive | |||
| 21060732-02 | T₀ | 1 | 29.1 | 29.2 | 28.8 | Positive | |
| 2 | 29.0 | 30.5 | 29.8 | Positive | |||
| 3 | 28.3 | 28.7 | 29.6 | Positive | |||
| T₂₃->₄₈ | 1 | 29.2 | 28.9 | 29.8 | Positive | ||
| 2 | 29.4 | 29.8 | 30.5 | Positive | |||
| 3 | 28.5 | 29.6 | 29.9 | Positive | |||
| T₄->₁₄₄ | 1 | 29.8 | 29.5 | 29.0 | Positive |
| Table 3. Specimen Stability | ||
|---|---|---|
| -- | ----------------------------- | -- |
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| 2 | 29.2 | 29.0 | 29.5 | Positive | ||
|---|---|---|---|---|---|---|
| 3 | 30.2 | 30.5 | 30.9 | Positive | ||
| 21121032-01 | T0 | 1 | 28.1 | 28.9 | 29.7 | Positive |
| 2 | 29.8 | 28.7 | 28.3 | Positive | ||
| 3 | 28.1 | 29.5 | 29.8 | Positive | ||
| T23->48 | 1 | 30.0 | 30.9 | 29.7 | Positive | |
| 2 | 29.3 | 29.8 | 28.7 | Positive | ||
| 3 | 29.0 | 28.3 | 29.5 | Positive | ||
| T4->144 | 1 | 29.4 | 29.0 | 29.3 | Positive | |
| 2 | 29.1 | 29.4 | 29.6 | Positive | ||
| 3 | 29.4 | 29.3 | 29.1 | Positive |
The deviation between the initial C+ measurement value and the C+ measurement value of samples stored at either 23°C for a minimum of 48 hours or 4°C for a minimum of 144 hours is less than 2 C. The results demonstrated acceptable RNA stabilization at 23°C for 48 hours or 4°C for 144 hours.
3) Inactivation
Three lots of Dasky Disposable Sampling Tube (Model name: VSM02) were used for the inactivation assessment. In the experimental group, 30 µL SARS-CoV-2 virus at 1×105 Genomic Copy Equivalents (GCE)/mL (determined by real-time qPCR) was added to clinical nasopharyngeal (NP) swab specimens, collected from 9 healthy individuals who tested negative for SARS CoV-2 virus, then using the NP swab to transfer the virus sample into the Dasky Disposable Sampling Tube (Model name: VSM02), containing 3 mL media to achieve the final concentration 103 GCE/mL. In the control group, 30 µL SARS-CoV-2 virus with a titer of 1×105 GCE/mL was added to clinical NP swab specimens, collected from healthy individuals who tested negative for SARS CoV-2 virus, then using the NP swab to transfer the virus sample into 3 mL PBS (phosphoric acid buffer). The experimental group and the control group were incubated at room temperature for five (5) minutes. After 5 minutes, the samples of the experimental group and the control group were diluted 1:1000 with ultrapure water; 30 µL of diluted samples from the experimental group and control group were incubated with Vero-E6 cells (the cells were implanted in 96-well plates one day in advance, each well includes 30 µL Vero-E6 cells at 1x 105 GCE/mL), respectively. After 4 days of infection, the morphology of the cells was observed under an electron microscope to determine the cytological changes. By observing the cell morphology of the infected Vero-E6 cells, it was found that the virus in the control group could infect Vero-E6 cells. In the experimental group, the virus was inactivated and was no longer able to infect Vero-E6 cells. The intact morphology of the cells
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K211675
could be observed under the microscope. The results for the inactivation assessment are summarized in Table 4.
| Sample type (SARS-CoV-2 virus at 1x 103 GCE/mL) | Test number | LOT No.20100732-01 | LOT No.21060732-02 | LOT No.21121032-01 |
|---|---|---|---|---|
| Experimental group | 1# | uninfected | uninfected | uninfected |
| 2# | uninfected | uninfected | uninfected | |
| 3# | uninfected | uninfected | uninfected | |
| Control group | 1# | infected |
Table 4. Virus inactivation assessment
In the inactivation assessment, three batches of media in the Dasky Disposable Sampling Tube (Model name: VSM02) were tested. For the SARS-CoV-2 virus at a titer of 103 GCE/mL, it can be 100% inactivated at a minimum of 5 minutes in the Dasky Disposable Sampling Tube (Model name: VSM02).
4) Shelf life
The Shelf-life for the Dasky Disposable Sampling Tube (Model name: VSM02) is 1 year after the date of manufacture. The stability of the Dasky Disposable Sampling Tube (Model name: VSM02) was performed using Realtime stability study on a total of 9 samples (3 lots). The item appearance inspection, pH detection, RT-PCR test, virus inactivation efficiency detection and Limit of detection are considered as the factor of evaluation.
8. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device (K202641).
§ 866.2950 Microbial nucleic acid storage and stabilization device.
(a)
Identification. A microbial nucleic acid storage and stabilization device is a device that consists of a container and reagents intended to stabilize microbial nucleic acids in human specimens for subsequent isolation and purification of nucleic acids for further molecular testing. The device is not intended for preserving morphology or viability of microorganisms.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The intended use for the labeling required under § 809.10 of this chapter must include a detailed description of microorganisms and types of human specimens intended to be preserved.
(2) The labeling required under § 809.10(b) of this chapter must include the following:
(i) A detailed device description, including all device components;
(ii) Performance characteristics from applicable analytical studies, including nucleic acid stability and microorganism inactivation;
(iii) A limiting statement that erroneous results may occur when the transport device is not compatible with molecular testing; and
(iv) A limiting statement that the device has only been validated to preserve the representative microorganisms used in the analytical studies.
(3) Design verification and validation must include the following:
(i) Overall device design, including all device components and all control elements incorporated into the analytical validation procedures;
(ii) Thorough description of the microorganisms and methodology used in the validation of the device including, extraction platforms and assays used for the detection of preserved nucleic acids; and
(iii) The limit of detection (LoD) of the molecular test used to establish microorganism nucleic acid stability.