(335 days)
No
The device is a physical kit for collecting and transporting biological samples, with no mention of software, algorithms, or data processing capabilities.
No
The device is intended for the collection and transport of clinical specimens for diagnostic purposes, not for treating any medical condition.
No
This device is a sampling kit used for the collection and transport of clinical specimens to a laboratory for diagnostic techniques; it does not perform the diagnostic analysis itself.
No
The device description clearly outlines physical components: a sterile swab and a tube containing virus transport media. There is no mention of any software component.
Based on the provided text, the BioTeke Sterile Disposable Virus Sampling Kit is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "collection and transport of clinical specimens to the laboratory for standard diagnostic / identification techniques." This directly aligns with the purpose of IVD devices, which are used to examine specimens from the human body to provide information for diagnostic purposes.
- Diagnostic Assays: The intended use further specifies that the kit can be used for "respiratory viral diagnostic assays." This reinforces its role in the diagnostic process.
- Laboratory Use: The intended user is the "laboratory," which is where IVD testing is performed.
- Performance Studies: The performance studies describe testing related to "Virus recovery testing" and maintaining "viability of respiratory viruses," which are crucial aspects for a device used in diagnostic testing.
While the device itself is a collection and transport system, its intended purpose is to facilitate in vitro diagnostic testing by providing a suitable sample for laboratory analysis. Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
The BioTeke Sterile Disposable Virus Sampling Kit is intended for the collection and transport of clinical specimens to the laboratory for standard diagnostic / identification techniques. The BioTeke Sterile Disposable Virus Sampling Kit consists of a sterile swab and culture-based media that can be used for respiratory viral diagnostic assays including, Influenza, Respiratory Syncytial Virus (RSV) A and B, Parainfluenza, Adenovirus, and Rhinovirus.
Product codes
JSM
Device Description
The BioTeke Sterile Disposable Virus Sampling Swab Kit is a specimen collection and transport kit designed to collect a throat or nasal sample from the patient (utilizing the provided Specimen Collection Swab) and subsequently transferring the swab containing the patient's microbial sample into the provide 10mL polymer tube containing 3mL of VTM (Virus Transport Media)for purposes of transferring the swab and associated collected microorganisms into a transport container designed to preserve the sample during transport to the laboratory prior to laboratory analysis. The Specimen Collection Swab is designed with a break point (notched area on the shaft) to allow for the top of the VTM tube to close when the inoculated Specimen Collection Swab is placed into the BioTeke VTM tube.
The Bioteke Sterile Disposable Virus Sampling Swab Kit consists of the following: One (1) Specimen Collection Swab (sterile and individually packaged) One (1) Virus Transport Media (10mLpolymer tube containing 3mL of sterile VTM)
The Specimen Collection Swab measured 150mm with a breakpoint location (from the tip) at 80mm, a head length at 20mm and a head width of 3mm. The width of the Specimen Collection Swab measures 2.5mm. The 10mL polymer tubes are filled with 3mL of Virus Transport Media (VTM) and secured with a leak-proof polymer cap.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
throat or nasal
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)
Non-Clinical Testing:
- Virus recovery testing: Demonstrated that the BioTeke Sterile Disposable Virus Sampling Swab Kit meets the requirements of CSLI-M40-A2.
- Mechanical testing: Determined the BioTeke Sterile Disposable Virus Sampling Swab Kit to be substantially equivalent to the predicate device.
- Biocompatibility studies: Conducted per ISO 10993-1. Demonstrated that the Specimen Collection Swab component materials are safe for its intended use.
Virus Viability over Time:
- Study Type: Assessment of the ability of BioTeke Sterile Disposable Virus Sampling Kit to maintain viability of respiratory viruses by virus culture after storage at room temperature for 0h, 24h, 48h, 72h, and 120h.
- Key Results: Viruses (Influenza A, RSV A, RSV B, Parainfluenza, Adenovirus, Rhinovirus) stored at 23-25°C were maintained within 0.25 log (PFU/mL) of the input concentration of virus for 48 hours.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.2390 Transport culture medium.
(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 4, 2022
BioTeke Corporation (WuXi) Co., Ltd % Kenneth Kleinhenz Regulatory Affairs Consultant OSR Consulting 10807 Dakota Ranch Rd. Santee, California 92071
Re: K211707
Trade/Device Name: BioTeke Sterile Disposable Virus Sampling Kit Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: Class I, reserved Product Code: JSM, LIO Dated: May 28, 2021 Received: June 3, 2021
Dear Kenneth Kleinhenz:
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
1
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,
Maria Garcia, Ph.D. Assistant Director 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) K211707
Device Name
Bioteke Sterile Disposable Virus Sampling Swab Kit
Indications for Use (Describe)
The BioTeke Sterile Disposable Virus Sampling Kit is intended for the collection and transport of clinical specimens to the laboratory for standard diagnostic / identification techniques. The BioTeke Sterile Disposable Virus Sampling Kit consists of a sterile swab and culture-based media that can be used for respiratory viral diagnostic assays including, Influenza, Respiratory Syncytial Virus (RSV) A and B, Parainfluenza, Adenovirus, and Rhinovirus.
| 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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3
Date: 29 April 2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | BioTeke Corporation (WuXi) Co.,
Ltd 4th Floor, D5, No. 1719
Huishan Avenue, Wuxi City
(21474) Jiangsu, China |
|--------------------|-----------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Kenneth K. Kleinhenz Regulatory Affairs
Telephone (619) 244-9573
Kleinhenz64@gmail.com |
| DEVICE NAME | |
Classification Name: Trade/Proprietary Name: Culture Media, Non-Propagating Transport BioTeke Sterile Disposable Virus Sampling Swab Kit
ESTABLISHMENT REGISTRATION NUMBER: 3016837106
DEVICE CLASSIFICATION AND PRODUCT CODE
As shown in (21 CFR 866.2390), Transport Culture Medium devices consist of a semisolid, usually non-nutrient, medium that is intended to maintain the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. These devices are classified as Class I. Culture Media, Non-Propagating Transport have been assigned Product Code JSM.
INTENDED USE
The BioTeke Sterile Disposable Virus Sampling Kit is intended for collection and transport of clinical specimens to the laboratory for standard diagnostic/identification techniques. The BioTeke Sterile Disposable Virus Sampling Kit consists of a sterile swab and culture-based media that can be used for respiratory viral diagnostic assays including, Influenza, Respiratory Syncytial Virus (RSV) A and B, Parainfluenza, Adenovirus, and Rhinovirus.
4
DEVICE DESCRIPTION
Design Characteristics
The BioTeke Sterile Disposable Virus Sampling Swab Kit is a specimen collection and transport kit designed to collect a throat or nasal sample from the patient (utilizing the provided Specimen Collection Swab) and subsequently transferring the swab containing the patient's microbial sample into the provide 10mL polymer tube containing 3mL of VTM (Virus Transport Media)for purposes of transferring the swab and associated collected microorganisms into a transport container designed to preserve the sample during transport to the laboratory prior to laboratory analysis. The Specimen Collection Swab is designed with a break point (notched area on the shaft) to allow for the top of the VTM tube to close when the inoculated Specimen Collection Swab is placed into the BioTeke VTM tube.
The Bioteke Sterile Disposable Virus Sampling Swab Kit consists of the following: One (1) Specimen Collection Swab (sterile and individually packaged) One (1) Virus Transport Media (10mLpolymer tube containing 3mL of sterile VTM)
The Specimen Collection Swab measured 150mm with a breakpoint location (from the tip) at 80mm, a head length at 20mm and a head width of 3mm. The width of the Specimen Collection Swab measures 2.5mm. The 10mL polymer tubes are filled with 3mL of Virus Transport Media (VTM) and secured with a leak-proof polymer cap.
Material Composition
The single use Specimen Collection Swab is constructed of flocked polyester with an acrylonitrilebutadiene-styrene (ABS) shaft.
The 10mL polymer tubes are aseptically filled with 3mL of VTM (Virus Transport Media) that consists of 1X modified Hank's buffered salt solution consisting of the following:
| NaCl | MgSO4.7H2O |
|---|---|
| KCl | MgCl2.6H2O |
| CaCl2 | Na2HPO4.12H2O |
| KH2PO4 | Sodium bicarbonate |
| Glucose | Phenol Red sodium salt |
| Gentamicin | Polymyxin B |
5
EQUIVALENCE TO MARKETED PRODUCT
The BioTeke Sterile Disposable Virus Sampling Swab Kit shares indications and design principles with the following predicate devices: Puritan UTM-RT Collection and Transport System (K113249) and the Copan MSwab™ Collection, Preservation and Transport System (K121039); a Class I medical devices that were cleared for marketing in the United States under K113249 and K121039, respectively.
The BioTeke Sterile Disposable Virus Sampling Swab Kit device is substantially equivalent to the Puritan UTM-RT Collection and Transport System (K113249) predicate device in the following respects:
| Subject Device | Predicate Device | |
|---|---|---|
| Criteria | BioTeke Sterile Disposable Virus Sampling | |
| Swab Kit | Puritan UTM-RT Collection and Transport | |
| System | ||
| (K113249) | ||
| Intended Use | The BioTeke Sterile Disposable Virus Sampling Kit | |
| is intended for collection and transport of clinical | ||
| specimens to the laboratory for standard diagnostic / | ||
| identification techniques. The BioTeke Sterile | ||
| Disposable Virus Sampling Kit consists of a sterile | ||
| swab and culture-based media that can be used for | ||
| respiratory viral diagnostic assays including, | ||
| Influenza, Respiratory Syncytial Virus (RSV) A and | ||
| B, Parainfluenza, Adenovirus, and Rhinovirus | Puritan UTM -. RT Collection and Transport System | |
| is intended for the collection and transport of clinical | ||
| samples containing viruses, chlamydiae, | ||
| mycoplasmas and ureaplasmas from the collection | ||
| site to the testing laboratory. The specimen | ||
| transported in the Puritan UTM - RT can be used in | ||
| the laboratory to perform viral, chlamydial, | ||
| mycoplasmal and ureaplasmal culture | ||
| Individual Contents | 1 sterile individually wrapped specimen collection | |
| swab and |
1 polymer tube containing 3 mL viral transport
media | 1 sterile individually wrapped specimen
collection swab and
1 viral transport media polymer tube
containing 1mL or 3mL universal transport media |
| Swab | Flocked polyester with
acrylonitrile-butadiene-styrene (ABS) shaft | Flocked polyester with polystyrene
shaft |
| Swab Breakpoint | 80mm | 80mm and 100mm |
| Single Use Components | Yes | Yes |
| Transport Media
Volume | 3mL | 1mL or 3mL |
| Contents of
Viral Transport Media | Hank's Balanced Salt Solution
Gentamicin
Polymyxin B
Phenol Red Sodium Salt | Hank's Balanced Salt Solution
L-Glutamic Acid
Bovine Serum Albumin
Phenol Red
Gelatin Colistin
Sucrose
Amphotericin B
L-Cysteine Vancomycin
HEPES |
| Device Classification
Name | Culture Media, Non- propagating Transport | Culture Media, Non-propagating Transport |
| Regulation
(CFR Section) | 866.2390 | 866.2390 |
| Product Code | JSM | JSM |
| Class | 1 | 1 |
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PERFORMANCE TESTING
Non-Clinical Testing
Performance testing was conducted on BioTeke Sterile Disposable Virus Sampling Swab Kit. Virus recovery testing demonstrated that the BioTeke Sterile Disposable Virus Sampling Swab Kit meets the requirements of CSLI-M40-A2.
Mechanical testing was performed on the BioTeke Sterile Disposable Virus Sampling Swab Kit which determined the BioTeke Sterile Disposable Virus Sampling Swab Kit to be substantially equivalent to the predicate device.
Biocompatibility studies were conducted per ISO 10993-1 to demonstrate safety of the Bioteke Sterile Disposable Virus Sampling Swab Kit material. The biocompatibility studies demonstrated that the Specimen Collection Swab component of the BioTeke Sterile Disposable Virus Sampling Swab Kit materials are safe for its intended use.
Virus Viabilitv over Time
The ability of BioTeke Sterile Disposable Virus Sampling Kit to maintain viability of respiratory viruses was assessed by virus culture after storage at room temperature for 0h, 24h, 48h, 72h, and 120h. The results demonstrate that the viruses influenza, RSV A, RSV B, parainfluenza, adenovirus and thinovirus stored at 23-25°C were maintained within 0.25 log (PFU/mL) of the input concentration of virus for 48 hours as described in the table below.
| Virus Viability over
| Time | |||||
|---|---|---|---|---|---|
| Organism | pfu/ | ||||
| ml | |||||
| T=0 | pfu/ | ||||
| ml | |||||
| T=24 | pfu/ | ||||
| ml | |||||
| T=48 | T=48 | ||||
| hours Log | |||||
| reduction | |||||
| Influenza A | 85.7 | 64.0 | 54.0 | - 0.20 | |
| RSV A | 105.0 | 85.3 | 63.3 | - 0.22 | |
| RSV B | 106.7 | 84.7 | 64.3 | - 0.22 | |
| Parainfluenza | 167.3 | 141.7 | 104.0 | - 0.21 | |
| Adenovirus | 194.7 | 163.0 | 117.0 | - 0.22 | |
| Rhinovirus | 137.5 | 108.5 | 89 | - 0.21 |
Conclusion
Based on the test principle, design and performance characteristics of the device, the BioTeke Sterile Disposable Virus Sampling Kit is substantially equivalent to the predicate.