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.

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.

AI/ML Overview

The provided text describes the BioTeke Sterile Disposable Virus Sampling Kit and its substantial equivalence to predicate devices, primarily focusing on its intended use, design, and performance testing for virus viability.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Virus recovery testing demonstrated that the BioTeke Sterile Disposable Virus Sampling Swab Kit meets the requirements of CSLI-M40-A2." It also provides a table for "Virus Viability over Time," implying these are the performance criteria and results.

Acceptance Criteria (Implicit)	Reported Device Performance (Virus Viability over Time)
CSLI-M40-A2 Requirements	BioTeke Sterile Disposable Virus Sampling Swab Kit meets these requirements.
Virus Viability	Viruses maintained within 0.25 log (PFU/mL) of input concentration for 48 hours at 23-25°C.

Detailed Virus Viability Results:

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

Note: The negative log reduction values indicate a decrease in virus concentration, but within the specified threshold of 0.25 log (PFU/mL).

Additionally, Mechanical testing and Biocompatibility studies (per ISO 10993-1) were performed, and the device was deemed substantially equivalent to the predicate for these aspects and safe for its intended use, respectively. However, specific acceptance criteria and detailed performance metrics for these are not explicitly provided in the same granular detail as for virus viability.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the virus viability testing (e.g., number of replicates for each virus-time point combination).

Regarding data provenance, the study appears to be non-clinical testing, likely conducted in a laboratory setting. There is no information provided about the country of origin of the data or whether it was retrospective or prospective in the context of human subjects. Given it's a virus transport kit, the "samples" would be aliquots of virus cultures.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided in the document. The device in question is a virus sampling and transport kit, which involves laboratory performance testing (e.g., virus viability) rather than interpretation requiring human experts or ground truth in the context of medical imaging or diagnostic algorithms. The "ground truth" for this testing would be the initial known concentration of the viruses in vitro.

4. Adjudication Method for the Test Set

This is not applicable and not provided. As explained above, this isn't a study involving human interpretation or adjudication.

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

This is not applicable and not provided. This device is a physical medical device (virus sampling kit), not an AI-powered diagnostic tool used by human readers. Therefore, an MRMC comparative effectiveness study is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable and not provided. This device is a physical medical device. "Standalone" performance in the context of AI algorithms is not relevant here.

7. The Type of Ground Truth Used

The ground truth used for the virus viability testing was the initial known concentration (PFU/mL) of the specific respiratory viruses (Influenza A, RSV A, RSV B, Parainfluenza, Adenovirus, Rhinovirus) at time T=0 in the laboratory setting. This is an in vitro experimental ground truth.

8. The Sample Size for the Training Set

This is not applicable and not provided. Since this is a physical medical device undergoing performance testing, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

This is not applicable and not provided for the reasons mentioned above.

Summary

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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

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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,

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

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Indications for Use

510(k) Number (if known) K211707

Device Name

Bioteke Sterile Disposable Virus Sampling Swab Kit

Indications for Use (Describe)

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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Date: 29 April 2022

ADMINISTRATIVE INFORMATION

Manufacturer Name:	BioTeke Corporation (WuXi) Co.,Ltd 4th Floor, D5, No. 1719Huishan Avenue, Wuxi City(21474) Jiangsu, China
Official Contact:	Kenneth K. Kleinhenz Regulatory AffairsTelephone (619) 244-9573Kleinhenz64@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.

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DEVICE DESCRIPTION

Design Characteristics

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

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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 SamplingSwab Kit	Puritan UTM-RT Collection and TransportSystem(K113249)
Intended Use	The BioTeke Sterile Disposable Virus Sampling Kitis intended for collection and transport of clinicalspecimens to the laboratory for standard diagnostic /identification techniques. The BioTeke SterileDisposable Virus Sampling Kit consists of a sterileswab and culture-based media that can be used forrespiratory viral diagnostic assays including,Influenza, Respiratory Syncytial Virus (RSV) A andB, Parainfluenza, Adenovirus, and Rhinovirus	Puritan UTM -. RT Collection and Transport Systemis intended for the collection and transport of clinicalsamples containing viruses, chlamydiae,mycoplasmas and ureaplasmas from the collectionsite to the testing laboratory. The specimentransported in the Puritan UTM - RT can be used inthe laboratory to perform viral, chlamydial,mycoplasmal and ureaplasmal culture
Individual Contents	1 sterile individually wrapped specimen collectionswab and1 polymer tube containing 3 mL viral transportmedia	1 sterile individually wrapped specimencollection swab and1 viral transport media polymer tubecontaining 1mL or 3mL universal transport media
Swab	Flocked polyester withacrylonitrile-butadiene-styrene (ABS) shaft	Flocked polyester with polystyreneshaft
Swab Breakpoint	80mm	80mm and 100mm
Single Use Components	Yes	Yes
Transport MediaVolume	3mL	1mL or 3mL
Contents ofViral Transport Media	Hank's Balanced Salt SolutionGentamicinPolymyxin BPhenol Red Sodium Salt	Hank's Balanced Salt SolutionL-Glutamic AcidBovine Serum AlbuminPhenol RedGelatin ColistinSucroseAmphotericin BL-Cysteine VancomycinHEPES
Device ClassificationName	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 overTime
Organism	pfu/mlT=0	pfu/mlT=24	pfu/mlT=48	T=48hours Logreduction
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.

Regulation Number and Section

§ 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).