(374 days)
Not Found
No
The device is a chemical transport medium and does not involve any computational analysis or processing. The summary focuses on the chemical properties and performance of the medium for stabilizing viral RNA.
No
The device is described as an inactivated transport medium for the collection, stabilization, and transportation of specimens for diagnostic testing and does not provide therapy or treatment.
No
The device is a transport medium intended for the collection, stabilization, and transportation of clinical specimens for later testing, not for performing a diagnostic test itself.
No
The device description clearly states that the device is a transport medium (a liquid solution) and includes physical components like screw-cap tubes and swabs. This indicates it is a physical medical device, not software-only.
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, stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA from the collection site to the testing laboratory." This is a key characteristic of an IVD, as it is used to prepare a biological specimen for subsequent diagnostic testing.
- Specimen Type: It handles "upper respiratory clinical specimen," which is a biological sample.
- Target Analyte: It is intended to preserve "influenza A virus RNA," which is a specific analyte being tested for.
- Subsequent Use: The specimen collected in Biosci™ ITM is stated to be "suitable for use with compatible molecular assays." Molecular assays are a type of in vitro diagnostic test.
- Device Description: The description details the components and function of the medium in preparing the specimen for testing (inactivating the virus, lysing cells, stabilizing RNA).
- Performance Studies: The provided performance studies (Limit of Detection, Viral Stability, Inactivation) are typical studies conducted to demonstrate the suitability of an IVD for its intended purpose.
- Predicate Device: The mention of a predicate device (eNAT® - molecular collection and preservation medium) which is also a transport medium for molecular testing, further supports its classification as an IVD.
Based on the intended use, the type of specimen handled, the target analyte, and the subsequent use in molecular assays, Biosci™ Inactivated Transport Medium clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Biosci™ Inacivated Transport Medium (Biosei™ TM) is intended for the collection, stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA from the to the testing laboratory. The specimen collected in Biosci™ ITM is suitable for use with compatible molecular assays.
Product codes
QBD
Device Description
Biosci™ ITM contains a detergent and a protein denaturant to inactivate Flu A, lyse cells, disrupt lipid membranes, denature proteins and enzymes, and stabilize influenza A RNA. Therefore, Biosci™ ITM is not intended to be used for culture-based techniques. A specimen bag is also provided for safe transportation of specimens, as well as providing appropriate biosafety warning.
Biosci™ ITM has different configurations:
- A screw-cap tube filled with 1.0, 2.0, or 3.0 mL of Biosci™ ITM .
- A screw-cap tube filled with a range of media and package with an oropharyngeal swab for . oropharyngeal specimen collection
- . A screw-cap tube filled with a range of media and package with a nasopharyngeal swab for nasopharyngeal specimen collection
- . A screw-cap tube filled with a range of media and package with a mid-turbinate swab for mid-turbinate specimen collection
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Limit of Detection:
An analytical sensitivity study was conducted to determine the Flu A virus (H1N1 ATCC VR- 1736) Limit of Detection (LoD) obtained by Biosci™ ITM. The Flu A spiked into negative pooled nasopharyngeal clinical matrix at various concentrations was individually added onto a sterile swab that was added to Biosci™ ITM at a 1:10 dilution. The samples were then processed using a validated RT-PCR assay. The LoD of Biosci™ ITM for Flu A was determined to be 0.2 TCID50/mL.
Viral Stability:
A stability study was designed to demonstrate that RNA from Flu A is preserved and stable in Biosci™ ITM, as well as to demonstrate that the abilize Flu A RNA is not diminished with the aging of Biosci™ ITM. Flu A was diluted in negative pooled nasopharyngeal clinical matrix at 5× LoD and spotted onto swabs that were incubated in Biosci™ ITM at 1:10 dilution. The samples were then incubated at 2-8ºC and 25ºC for 0, 7, and 14 days to support a claim of stability for 14 days. The results confirmed that Flu A RNA stability in Biosci™ ITM met the pre-defined acceptance criteria of +/- 3.0 Ct value, when compared to day 0. Flu A RNA was stable in newly manufactured, unexpired lots that have just expired of Biosci™ ITM for up to 14 days when stored at both 2-8°C. This study also demonstrates Biosci™ ITM's ability to stabilize Flu A RNA within the claimed 18-month shelf life.
Inactivation:
An inactivation study was conducted to verify that Biosci™ Inactivated Transport Medium (Biosci™ ITM) inactivates Flu A virus as efficiently as the predicate device.
Flu A at concentrations of 1.2×10^9, and 1.2×10^8 TCID50/mL were diluted in negative pooled nasopharyngeal clinical matrix. Each concentration was added to a sterile swab that was then incubated in Biosci™ ITM at a 1:10 dilution for 10, 20, and 30 seconds. Flu A at 1.2 x 10^9, and 1.2 x 10^8 TCID50/mL were used as control both without matrix in the absence of Biosci™ ITM. The viability of the virus was measured at each time point after incubation in Biosci™ ITM by inoculating aliquots onto MDCK (Madin-Darby Canine Kidney) cell lines, incubating for four days and measuring the cytopathic effect (CPE). The results for the inactivation study confirmed >4.0 log reduction in Flu A titer at 10, 20, and 30 seconds incubation in Biosci™ ITM, which demonstrates the inactivation performance of Biosci™ ITM is similar to the predicate with regard to Flu A.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
LoD of Biosci™ ITM for Flu A was determined to be 0.2 TCID50/mL.
Flu A RNA stability in Biosci™ ITM met the pre-defined acceptance criteria of +/- 3.0 Ct value, when compared to day 0.
Inactivation study confirmed >4.0 log reduction in Flu A titer.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo, which includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.
January 19, 2023
Shenzhen Dakewe Bio-engineering Co., Ltd. Wei Jiang Deputy General Manager No.14 Jinhui Road, Kengzi Street, Pingshan District Shenzhen, Guangdong 518122 China
Re: K220059
Trade/Device Name: Biosci™ Inactivated Transport Medium, Biosci™ ITM Regulation Number: 21 CFR 866.2950 Regulation Name: Microbial Nucleic Acid Storage And Stabilization Device Regulatory Class: Class II Product Code: QBD Dated: December 31, 2021 Received: January 10, 2022
Dear Wei Jiang:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
542 of the Act); 21 CFR 1000-1050.
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 (QS) 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-
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Biosci™ Inactivated Transport Medium
Indications for Use (Describe)
Biosci™ Inacivated Transport Medium (Biosei™ TM) is intended for the collection, stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA from the to the testing laboratory. The specimen collected in Biosci™ ITM is suitable for use with compatible molecular assays.
| 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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Image /page/3/Picture/0 description: The image shows the logo for DAKEWE. The logo consists of a circular graphic on the left and the word "DAKEWE" on the right. The circular graphic is divided into three sections, with two sections in light blue and one section in yellow.
510(k) Summary Biosci™ Inactivated Transport Medium
| I. SUBMITTER | |
|---|---|
| Applicant Name: | Shenzhen Dakewe Bio-engineering Co., Ltd. |
| No.14 Jinhui Road, Kengzi Street Pingshan District | |
| Shenzhen, China | |
| Contact Person: | Wei Jiang |
| Deputy General Manager | |
| Telephone: | +86-755-86235300 |
| Establishment Registration Number: | 3017170972 |
| Date Prepared: | December 30, 2021 |
| II. DEVICE – CLASSIFIICATION | |
| Proprietary Name | Biosci™ Inactivated Transport Medium |
| Common/Usual Name | Biosci™ ITM |
| Device | Transport device for the stabilization of microbial |
| nucleic acids | |
| Classification Number | 21 CFR 866.2950 |
| Product Code | QBD |
| Device Class | Class II |
| Review Panel | Microbiology |
| III. PREDICATE DEVICE – CLASSIFICATION | |
| Device Name | eNAT® - molecular collection and preservation |
| medium | |
| 510(k) Number | K201849 |
| Device | Transport device for the stabilization of microbial |
| nucleic acids | |
| Classification Number | 21 CFR 866.2950 |
| Product Code | QBD |
| Device Class | Class II |
| Review Panel | Microbiology |
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Image /page/4/Picture/0 description: The image contains the logo for DAKEWE. The logo consists of a circular graphic on the left and the company name "DAKEWE" on the right. The circular graphic is divided into three sections, with two sections in light blue and one section in yellow. The company name "DAKEWE" is written in a bold, sans-serif font.
IV. INTENDED USE OF THE DEVICE
Biosci™ Inactivated Transport Medium (Biosci™ ITM) is intended for the collection, inactivation, stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA from the collection site to the testing laboratory. The specimen collected in Biosci™ ITM is suitable for use with compatible molecular assays.
V. DEVICE DESCRIPTION
Biosci™ ITM contains a detergent and a protein denaturant to inactivate Flu A, lyse cells, disrupt lipid membranes, denature proteins and enzymes, and stabilize influenza A RNA. Therefore, Biosci™ ITM is not intended to be used for culture-based techniques. A specimen bag is also provided for safe transportation of specimens, as well as providing appropriate biosafety warning.
Biosci™ ITM has different configurations:
- A screw-cap tube filled with 1.0, 2.0, or 3.0 mL of Biosci™ ITM .
- A screw-cap tube filled with a range of media and package with an oropharyngeal swab for . oropharyngeal specimen collection
- . A screw-cap tube filled with a range of media and package with a nasopharyngeal swab for nasopharyngeal specimen collection
- . A screw-cap tube filled with a range of media and package with a mid-turbinate swab for mid-turbinate specimen collection
VI. COMPARSION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PPREDICATE DEVICE
Biosci™ ITM is substantially equivalent in intended use and overall function to the predicate device eNAT® molecular collection and preservation medium by Copan Italia S.p.A..
The eNAT® by Copan Italia S.p.A. is provided both in tube and in kit format. The eNAT® tube format is provided ready to use in a screw-cap polypropylene tube containing 2 mL of medium for the inactivation of Flu A and the stabilization of the Flu A virus RNA. The eNAT® kit format consists of media-filled tube with a nylon flocked swab.
The Biosci™ ITM is supplied both in tube and in kit format. The Biosci™ ITM tube format is provided in a screw-cap polypropylene tubes designed for transport of the clinical sample, containing 1, 2, or 3 mL of Biosci™ ITM for the inactivation of Flu A and the stabilization of the Flu A virus RNA. The Biosci™ ITM kit format consists of a pre-filled tube with a nylon flocked swab. The Biosci™ ITM kit will include one of the following swab types: nasopharyngeal swab, oropharyngeal swab or mid-turbinate swab. While the Biosci™ ITM kit is available with three different swab configurations, the predicate device is available with two swab configurations which include nasopharyngeal swab or oropharyngeal swab.
The Biosci™ ITM and eNAT® medium both contain guanidine salt and detergents. These media components inactive Flu A, denature and lyse cells, and stabilize Flu A virus RNA. See Table 1: Side-by-Side Comparison of Biosci™ ITM and Predicate Device.
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| Device & Predicate
| Device(s): | Device: K220059 | Predicate: K201849 | |
|---|---|---|---|
| Device Trade Name | Biosci Inactivated | ||
| Transport Medium | eNAT molecular collection and | ||
| preservation medium | |||
| Intended Use/Indications For | |||
| Use | Biosci Inactivated | ||
| Transport Medium (Biosci | |||
| ITM) is intended for the | |||
| collection, stabilization and | |||
| transportation of an | |||
| unprocessed upper | |||
| respiratory clinical | |||
| specimen suspected of | |||
| containing influenza A | |||
| virus RNA from the | |||
| collection site to the testing | |||
| laboratory at room | |||
| temperature. The specimen | |||
| collected in Biosci ITM is | |||
| suitable for use with | |||
| compatible molecular | |||
| assays. | Copan eNAT- molecular | ||
| collection and preservation | |||
| medium- is intended for the | |||
| stabilization, transportation and | |||
| inactivation of an unprocessed | |||
| upper respiratory clinical | |||
| specimen suspected of | |||
| containing influenza A virus | |||
| RNA. eNAT- molecular | |||
| collection and preservation | |||
| medium- is intended for use with | |||
| compatible molecular assays. | |||
| General Device | |||
| Characteristic Similarities | |||
| Single use device | Yes | Same | |
| Specimen types | Upper respiratory | ||
| specimens | Same | ||
| Microorganism nucleic acids | |||
| preserved | Influenza A virus | Same | |
| Container | Tube; plastic; conical | ||
| bottom self-standing with a | |||
| screw cap | Same | ||
| Shelf-life | 18 months | Same | |
| General Device | |||
| Characteristic Differences | |||
| Media formulation | -Guanidine hydrochloride | ||
| -EDTA disodium salt | |||
| dihydrate | |||
| -Trisodium citrate | |||
| dihydrate | |||
| -Tris | |||
| -TCEP | |||
| -HCl | |||
| -Antifoam A Concentrate | |||
| -NP-40 | |||
| -Distilled water | -Tris-EDTA | ||
| -Guanidine thiocyanate | |||
| -Detergent | |||
| -HEPES | |||
| -Distilled water | |||
| Media volume | 1, 2, and 3 mL | 2 mL | |
| Swabs | Nylon flocked swabs | ||
| (nasopharyngeal, | |||
| oropharyngeal and mid- | |||
| turbinate) | Nylon flocked swabs | ||
| (nasopharyngeal, oropharyngeal) | |||
| Specimen stability | Up to 14 days at 2-25°C | Up to 28 days at 2-25°C | |
| Storage temperature | 18-25°C | 2-25°C |
Table 1: Side-by-Side Comparison of Biosci™ ITM and Predicate Device
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Image /page/6/Picture/0 description: The image shows the logo for DAKEWE. The logo consists of a circular graphic on the left and the word "DAKEWE" on the right. The circular graphic is divided into three sections, with two sections in light blue and one section in yellow. The word "DAKEWE" is written in a bold, sans-serif font.
VII. PERFORMANCE DATA
Limit of Detection:
An analytical sensitivity study was conducted to determine the Flu A virus (H1N1 ATCC VR- 1736) Limit of Detection (LoD) obtained by Biosci™ ITM. The Flu A spiked into negative pooled nasopharyngeal clinical matrix at various concentrations was individually added onto a sterile swab that was added to Biosci™ ITM at a 1:10 dilution. The samples were then processed using a validated RT-PCR assay. The LoD of Biosci™ ITM for Flu A was determined to be 0.2 TCID50/mL (Table 2).
| Biosci™ ITM samples | |
|---|---|
| Number of positive replicates | 24/24 |
| AVG (Ct value) | 35.79 |
| SD (Ct value) | 0.67 |
| Table 2 Summary of results obtained at the dilution corresponding to | |
|---|---|
| 0.2 TCID50/mL during the LoD study |
Viral Stability:
A stability study was designed to demonstrate that RNA from Flu A is preserved and stable in Biosci™ ITM, as well as to demonstrate that the abilize Flu A RNA is not diminished with the aging of Biosci™ ITM. Flu A was diluted in negative pooled nasopharyngeal clinical matrix at 5× LoD and spotted onto swabs that were incubated in Biosci™ ITM at 1:10 dilution. The samples were then incubated at 2-8ºC and 25ºC for 0, 7, and 14 days to support a claim of stability for 14 days. The results of Flu A RNA Stability Study with Biosci™ ITM for the claimed 14 days are shown in Tables 3 and 4, which confirmed that Flu A RNA stability in Biosci™ ITM met the pre-defined acceptance criteria of +/- 3.0 Ct value, when compared to day 0. Flu A RNA was stable in newly manufactured, unexpired lots that have just expired of Biosci™ ITM for up to 14 days when stored at both 2-8°C. This study also demonstrates Biosci™ ITM's ability to stabilize Flu A RNA within the claimed 18-month shelf life.
| Days (2-8°C) | 0 | 7 | 14 |
|---|---|---|---|
| AVG (Ct value): | 32.26 | 31.97 | 31.58 |
| Variation (Ct value): | - | -0.29 | -0.68 |
| SD (Ct value): | 0.22 | 0.29 | 0.31 |
Table 3 Flu A stability in Biosci™ ITM for 14 days at 2-8℃
| Table 4 Flu A stability in Biosci™ ITM for 14 days at 25℃ | |||
|---|---|---|---|
| Days (25°C) | 0 | 7 | 14 |
| AVG (Ct value): | 32.20 | 32.03 | 31.55 |
| Variation (Ct value): | - | -0.17 | -0.65 |
| SD (Ct value): | 0.31 | 0.23 | 0.28 |
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Image /page/7/Picture/0 description: The image shows the logo for DAKEWE. The logo consists of a circular graphic on the left and the word "DAKEWE" on the right. The circular graphic is divided into three sections, with two sections in light blue and one section in yellow. The word "DAKEWE" is written in a bold, sans-serif font and is black in color.
Inactivation:
An inactivation study was conducted to verify that Biosci™ Inactivated Transport Medium (Biosci™ ITM) inactivates Flu A virus as efficiently as the predicate device.
Flu A at concentrations of 1.2×10°, and 1.2×10° TCIDsolmL were diluted in negative pooled nasopharyngeal clinical matrix. Each concentration was added to a sterile swab that was then incubated in Biosci™ ITM at a 1:10 dilution for 10, 20, and 30 seconds. Flu A at 1.2 x 10 , and 1.2 x 10 TCD30/mL were used as control both without matrix in the absence of Biosci™ ITM (Table 5). The viability of the virus was measured at each time point after incubation in Biosci™ ITM by inoculating aliquots onto MDCK (Madin-Darby Canine Kidney) cell lines, incubating for four days and measuring the cytopathic effect (CPE). The results for the inactivation study confirmed >4.0 log reduction in Flu A titer at 10, 20, and 30 seconds incubation in Biosci™ ITM (Table 6), which demonstrates the inactivation performance of Biosci™ ITM is similar to the predicate with regard to Flu A. Also, as noted in the table, CPE was still observed in samples with
starting viral concentrations of ≥109 TCIDs/mL. Although reduced by ≥5 logs by the Biosci™ ITM, CPE was observed because this high viral concentration exceeds the working range of the cell culture-based assay, and the effect of the inactivation media can no longer be adequately assessed. Data from the lower viral concentrations were used to assess the inactivation performance, which was acceptable.
| Preincubation (TCID50/mL) | Presence of CPE | |
|---|---|---|
| Flu A only | 1.2 x 105 | Yes |
| 1.2 x 104 | Yes | |
| 1.2 x 103 | Yes | |
| Flu A and matrix | 1.2 x 105 | Yes |
| 1.2 x 104 | Yes | |
| 1.2 x 103 | Yes | |
| Matrix only | - | No |
| Biosci TM ITM only * | - | No |
Table 5 Flu A Inactivation Study Data Summary for Control Groups
| Sample | Starting Flu A
concentration | 10s incubation
(TCID50 LogΔ) | 20s incubation
(TCID50 LogΔ) | 30s incubation
(TCID50 LogΔ) | Presence of
CPE |
|----------------------------------|---------------------------------|---------------------------------|---------------------------------|---------------------------------|--------------------|
| Flu A, matrix and
Biosci™ ITM | 1.2 x 109 | ≥-5.0 | ≥-5.0 | ≥-5.0 | Yes |
| | 1.2 x 108 | >-5.0 | >-5.0 | >-5.0 | No |
| | 1.2 x 107 | >-4.0 | >-4.0 | >-4.0 | No |
Table 6 Flu A inactivation in Biosci™ ITM
*Biosci™ ITM showed no cytotoxicity on MDCK cells when diluted to 1:1,000.
VII. CONCLUSIONS
Based on the above, Shenzhen Dakewe Bio-engineering Co., Ltd. has demonstrated that Biosci™ Inactivated Transport Medium is substantially equivalent to the predicate device for collection, stabilization, inactivation and transportation of clinical specimens containing Flu A from the collection site to the testing laboratory. No new issues of safety or effectiveness were found for Biosci™ Inactivated Transport Medium.