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. The specimen collected in Biosci™ ITM is suitable for use with compatible molecular assays.

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Biosci™ Inactivated Transport Medium, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Limit of Detection (LoD)	Not explicitly stated as a numerical criterion, but implied to be sufficient for detection. Demonstrated sensitivity for Flu A.	0.2 TCID50/mL for Flu A (H1N1 ATCC VR-1736)
Viral Stability (Flu A RNA)	Ct value variation within +/- 3.0 Ct compared to Day 0.	For 14 days at 2-8°C: Day 7 variation: -0.29 Ct Day 14 variation: -0.68 Ct. For 14 days at 25°C: Day 7 variation: -0.17 Ct Day 14 variation: -0.65 Ct. All within +/- 3.0 Ct.
Inactivation (Flu A)	>4.0 log reduction in Flu A titer.	>4.0 log reduction in Flu A titer at 10, 20, and 30 seconds incubation. (For concentrations 1.2 x 10^7 and 1.2 x 10^8 TCID50/mL).

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

Limit of Detection: 24 positive replicates were used.
Viral Stability: Not explicitly stated as a number of replicates per time point for the stability study, but Flu A was diluted at 5x LoD and spotted onto swabs. The study involved incubation at two temperatures (2-8ºC and 25ºC) for 0, 7, and 14 days. This implies multiple samples for each time point and condition.
Inactivation: Multiple starting concentrations of Flu A (1.2 x 10^7, 1.2 x 10^8, 1.2 x 10^9 TCID50/mL) were tested. For each concentration, samples were incubated for 10, 20, and 30 seconds. Control groups included Flu A only, Flu A and matrix, matrix only, and Biosci™ ITM only.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "negative pooled nasopharyngeal clinical matrix," suggesting the use of clinical samples, but the study design is analytical (laboratory-based) rather than clinical.

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

This device is a transport medium for stabilizing microbial nucleic acids, not an interpretative diagnostic device that requires expert review for ground truth in the same way an imaging AI algorithm would.
The ground truth for the analytical studies (LoD, Viral Stability, Inactivation) was established based on laboratory assays (RT-PCR and cell culture-based assay for CPE), not human expert consensus. Therefore, no "experts" in the traditional sense of human readers for images or clinical diagnoses were used.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by laboratory measurements, not human interpretation requiring 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

No. This is an analytical study for a transport medium device, not an AI diagnostic algorithm, so an MRMC study is not relevant or applicable.

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

Not applicable. This device is a transport medium, not an algorithm. Its performance is evaluated in standalone, laboratory-based analytical studies as described above.

7. The Type of Ground Truth Used

The ground truth for the studies was established through laboratory assays:
- LoD and Viral Stability: Quantified Flu A RNA using a "validated RT-PCR assay."
- Inactivation: Measured viral viability by observing the "cytopathic effect (CPE)" on MDCK cell lines.

8. The Sample Size for the Training Set

Not applicable. This is a transport medium device, not an AI/machine learning algorithm, so there is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for this type of device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

K220059

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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510(k) Summary Biosci™ Inactivated Transport Medium

I. SUBMITTER
Applicant Name:	Shenzhen Dakewe Bio-engineering Co., Ltd.
	No.14 Jinhui Road, Kengzi Street Pingshan DistrictShenzhen, 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 microbialnucleic 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 preservationmedium
510(k) Number	K201849
Device	Transport device for the stabilization of microbialnucleic acids
Classification Number	21 CFR 866.2950
Product Code	QBD
Device Class	Class II
Review Panel	Microbiology

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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 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 & PredicateDevice(s):	Device: K220059	Predicate: K201849
Device Trade Name	Biosci InactivatedTransport Medium	eNAT molecular collection andpreservation medium
Intended Use/Indications ForUse	Biosci InactivatedTransport Medium (BiosciITM) is intended for thecollection, stabilization andtransportation of anunprocessed upperrespiratory clinicalspecimen suspected ofcontaining influenza Avirus RNA from thecollection site to the testinglaboratory at roomtemperature. The specimencollected in Biosci ITM issuitable for use withcompatible molecularassays.	Copan eNAT- molecularcollection and preservationmedium- is intended for thestabilization, transportation andinactivation of an unprocessedupper respiratory clinicalspecimen suspected ofcontaining influenza A virusRNA. eNAT- molecularcollection and preservationmedium- is intended for use withcompatible molecular assays.
General DeviceCharacteristic Similarities
Single use device	Yes	Same
Specimen types	Upper respiratoryspecimens	Same
Microorganism nucleic acidspreserved	Influenza A virus	Same
Container	Tube; plastic; conicalbottom self-standing with ascrew cap	Same
Shelf-life	18 months	Same
General DeviceCharacteristic Differences
Media formulation	-Guanidine hydrochloride-EDTA disodium saltdihydrate-Trisodium citratedihydrate-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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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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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 Aconcentration	10s incubation(TCID50 LogΔ)	20s incubation(TCID50 LogΔ)	30s incubation(TCID50 LogΔ)	Presence ofCPE
Flu A, matrix andBiosci™ 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.

Regulation Number and Section

§ 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.