(389 days)
Not Found
No
The device is a collection and transport medium for viral specimens and does not involve any computational analysis or algorithms.
No.
The device is intended for collection and transport of specimens for diagnostic purposes, not for treating a medical condition.
No
Explanation: The device is a sampler and transport medium for specimens, not a diagnostic device itself. It is used to prepare specimens for diagnostic techniques performed in a laboratory.
No
The device description clearly outlines physical components including preservation tubes, VTM (Viral Transport Media), and swabs made of specific materials. This indicates a hardware-based medical device, not a software-only one.
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 and transport of upper respiratory clinical specimens to the laboratory for standard diagnostic or identification techniques." It also mentions that the Viral Transport Medium can be used in the laboratory to "perform culture, isolation and detection of upper respiratory viruses." This clearly indicates that the device is intended to be used in vitro (outside the body) for diagnostic purposes.
- Device Description: The device is a "Disposable Sampler (Viral Transport Medium)" which is a collection and transport system for biological specimens. This type of device is a common component in in vitro diagnostic workflows.
- Performance Studies: The performance studies described evaluate the device's ability to preserve and recover viruses for subsequent laboratory testing (culture-based viral recovery studies). This further supports its role in the diagnostic process.
- Intended User / Care Setting: The intended user is the "laboratory," which is where in vitro diagnostic testing is performed.
Based on these points, the NEST Disposable Sampler (Viral Transport Medium) fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NEST Disposable Sampler (Viral Transport Medium) is intended for the collection and transport of upper respiratory clinical specimens to the laboratory for standard diagnostic or identification techniques. The Viral Transport Medium can be used in the laboratory to perform culture, isolation and detection of upper respiratory viruses including Influenza A, Rhinovirus, and Respiratory Syncytial Virus (RSV).
Product codes (comma separated list FDA assigned to the subject device)
JSM
Device Description
The Disposable Sampler Viral Transport Media is composed of preservation tubes filled with VTM (Viral Transport Media), kitted with or without swabs, depending on the product type. The Disposable Sampler Viral Transport Media is composed of Sodium chloride, Disodium hydrogen phosphate dodecahydrate, Potassium chloride, Potassium dihydrogen phosphate, Magnesium sulfate heptahydrate, Glucose, HEPES, Sodium bicarbonate, Fluconazole, Gentamicin sulfate, Griseofulvin, Polymyxin sulfate, Phenol red (optional), Sodium hydroxide, Calcium chloride, Bovine serum albumin and L-Cysteine. The preservation tube is made of medical-grade polypropylene materials. For both oropharyngeal and nasopharyngeal swabs, the swab head is made of flocked nylon fiber, and the rod is made of ABS (acrylonitrile butadiene styrene).
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)
Culture-Based Viral Recovery Studies:
To demonstrate safety and effectiveness of Disposable Sampler Viral Transport Media and to show substantial equivalence to the predicate device, Wuxi Nest completed the following nonclinical tests. Performance of the NEST Disposable Samplers were evaluated for viral recovery using commercial strains of Influenza A virus A/PR/8/34 H1N1, Rhinovirus Type 16, and Respiratory syncytial virus Type A. A 100ul aliquot of virus culture with 10° TCID50ml virus was added into 900ul of different batches of preservation solution (three lots) with negative clinical nasopharyngeal matrix collected from healthy subjects. After mixing, the samples were then stored at 23-25 ℃ (room temperature) and 2-8 ℃ (refrigerated) for 0, 24, and 48 hours. Different lots of preservation solution without virus dilution were used as controls with negative clinical nasopharyngeal matrix collected from healthy subjects. At each timepoint, an aliquot of the preservation solution, matrix and organism suspension was inoculated into the appropriate host cell line. Finally, the number of plaques formed on the host cells by the recovered viable virus were calculated. All the cultures were processed using standard laboratory culture techniques. Each time point was assessed in triplicate and the average value was taken as the final value. The results of the viral recovery studies are represented in Table 2 and show the attenuation rate of the viruses tested at different temperatures and times. The NEST Disposable Samplers preserved the samples of all the viruses tested for up to 48 hours at both room temperature and when refrigerated. The results confirm that the media stabilizes the target viruses meeting the performance specifications for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
May 20, 2022
Wuxi Nest Biotechnology Co., Ltd. % Randy Jiang Senior Technical Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K211256
Trade/Device Name: Disposable Sampler Viral Transport Media Regulation Number: 21 CFR 866.2390 Regulation Name: Transport culture medium Regulatory Class: Class I, reserved Product Code: JSM Dated: April 23, 2021 Received: April 26, 2021
Dear Randy 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
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,
Ribhi Shawar, Ph.D. (ABMM) Branch Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
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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3
510(k) Summary
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
| Submitter Information | |
|---|---|
| Company: | Cheng Zhiwei |
| RA Manager | |
| Wuxi NEST Biotechnology Co., Ltd. | |
| No.530 Xida Road, New District, Wuxi | |
| 214112 China | |
| Telephone: 0086-510-68006788 | |
| Email: project01@nest-wuxi.com | |
| Contact: | Randy Jiang |
| Senior Technical Consultant | |
| Emergo Global Consulting, LLC | |
| 2500 Bee Cave Road, Building 1, Suite 300 | |
| Austin, Texas, 78746, USA | |
| Telephone: (512) 327-9997 | |
| Fax: (512) 327-9998 | |
| LST.AUS.ProjectManagement@ul.com | |
| Date Summary Prepared: | March 29, 2022 |
| Name of the Device | |
| Trade Name: | |
| Common Name: | Disposable Sampler Viral Transport Media |
| Transport culture medium | |
| Classification Name: | Microbiology |
| Review Panel: | Microbiology (MI) |
| Regulation: | 866.2390 |
| Class: | Class I |
| Product Code: | JSM |
Equivalence Claimed to Predicate Device
The Disposable Sampler Viral Transport Media is equivalent to the COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM (K042970), manufactured by COPAN DIAGNOSTICS, INC.
4
Device Description
The Disposable Sampler Viral Transport Media is composed of preservation tubes filled with VTM (Viral Transport Media), kitted with or without swabs, depending on the product type. The Disposable Sampler Viral Transport Media is composed of Sodium chloride, Disodium hydrogen phosphate dodecahydrate, Potassium chloride, Potassium dihydrogen phosphate, Magnesium sulfate heptahydrate, Glucose, HEPES, Sodium bicarbonate, Fluconazole, Gentamicin sulfate, Griseofulvin, Polymyxin sulfate, Phenol red (optional), Sodium hydroxide, Calcium chloride, Bovine serum albumin and L-Cysteine. The preservation tube is made of medical-grade polypropylene materials. For both oropharyngeal and nasopharyngeal swabs, the swab head is made of flocked nylon fiber, and the rod is made of ABS (acrylonitrile butadiene styrene).
Indication for Use Statement
The NEST Disposable Sampler (Viral Transport Medium) is intended for the collection and transport of upper respiratory clinical specimens to the laboratory for standard diagnostic or identification techniques. The Viral Transport Medium can be used in the laboratory to perform culture, isolation and detection of upper respiratory viruses including Influenza A, Rhinovirus, and Respiratory Syncytial Virus (RSV).
Substantial Equivalence Discussion
The following table compares the Disposable Sampler Viral Transport Media to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
| Device & Predicate
| Device(s): | Device K211256 | Predicate K042970 |
|---|---|---|
| Device Trade Name | NEST Disposable | |
| Sampler Viral | ||
| Transport Media | Copan universal | |
| transport medium | ||
| (UTM-RT) system | ||
| General Device | ||
| Characteristic Similarities | ||
| Intended | ||
| Use/Indications For | ||
| Use | The NEST | |
| Disposable | ||
| Sampler (Viral | ||
| Transport | ||
| Medium) is | Copan Universal | |
| Transport Medium | ||
| (UTM-RT) System | ||
| is intended for the | ||
| collection and | ||
| intended for the | ||
| collection and | ||
| transport of upper | ||
| respiratory clinical | ||
| specimens to the | ||
| laboratory for | ||
| standard diagnostic | ||
| or identification | ||
| techniques. The | ||
| Viral Transport | ||
| Medium can be | ||
| used in the | ||
| laboratory to | ||
| perform culture, | ||
| isolation and | ||
| detection of upper | ||
| respiratory viruses | ||
| including | ||
| Influenza A, | ||
| Rhinovirus, and | ||
| Respiratory | ||
| Syncytial Virus | ||
| (RSV). | transport of | |
| clinical specimens | ||
| containing viruses, | ||
| chlamydiae, | ||
| mycoplasma or | ||
| ureaplasma from | ||
| the collection site | ||
| to the testing | ||
| laboratory. UTM- | ||
| RT can be | ||
| processed using | ||
| standard clinical | ||
| laboratory | ||
| operating | ||
| procedures for | ||
| viral, chlamydial, | ||
| mycoplasma and | ||
| ureaplasma | ||
| culture. | ||
| Device Product Code | ||
| and Classification | JSM, Class I | JSM, Class I |
| Shelf Life | 12 months | 12 months |
| pH | pH 7.3 ± 0.2 at | |
| 25°C | pH 7.3 ± 0.2 at | |
| 25°C | ||
| General Device | ||
| Characteristic | ||
| Differences | ||
| Media formulation | HANK's Balanced | |
| Salts Solution, | ||
| HEPES, Sodium | ||
| bicarbonate | HANK's Balanced | |
| Salts, BSA, L- | ||
| cysteine, gelatin, | ||
| sucrose, L- | ||
| Fluconazole, | ||
| Gentamicin | ||
| sulfate, | ||
| Griseofulvin, | ||
| Polymyxin sulfate, | ||
| Phenol red, | ||
| Sodium hydroxide, | ||
| glucose, BSA and | ||
| L-cysteine. | glutamic acid, | |
| HEPES buffer, | ||
| vancomycin, | ||
| amphotericin B, | ||
| colistin, phenol red | ||
| Vial Specification | 5 mL vial: 2.5 mL VTM | |
| 10 mL vial: 3.0 mL VTM | 1 mL UTM in | |
| 12x80 mm tube | ||
| 3 mL UTM in | ||
| 16x100 mm tube | ||
| 10 mL UTM in | ||
| 25x90 mm tube | ||
| Supported claims to | ||
| perform culture, | ||
| isolation and detection | ||
| of: | Influenza A, | |
| Rhinovirus, and | ||
| Respiratory | ||
| Syncytial Virus | ||
| (RSV) | chlamydiae, | |
| mycoplasma or | ||
| ureaplasma and | ||
| viruses | ||
| pH indicator | Optional | None |
Table 1: Subject and Predicate Device Comparison Table
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6
Non-Clinical Performance Data
Culture-Based Viral Recovery Studies
To demonstrate safety and effectiveness of Disposable Sampler Viral Transport Media and to show substantial equivalence to the predicate device, Wuxi Nest completed the following nonclinical tests. Performance of the NEST Disposable Samplers were evaluated for viral recovery using commercial strains of Influenza A virus A/PR/8/34 H1N1, Rhinovirus Type 16, and Respiratory syncytial virus Type A. A 100ul aliquot of virus culture with 10° TCID50ml virus was added into 900ul of different batches of preservation solution (three lots) with negative clinical nasopharyngeal matrix collected from healthy subjects. After mixing, the samples were then stored at 23-25 ℃ (room temperature) and 2-8 ℃ (refrigerated) for 0, 24, and 48 hours. Different lots of preservation solution without virus dilution were used as controls with negative
7
clinical nasopharyngeal matrix collected from healthy subjects. At each timepoint, an aliquot of the preservation solution, matrix and organism suspension was inoculated into the appropriate host cell line. Finally, the number of plaques formed on the host cells by the recovered viable virus were calculated. All the cultures were processed using standard laboratory culture techniques. Each time point was assessed in triplicate and the average value was taken as the final value. The results of the viral recovery studies are represented in Table 2 below and show the attenuation rate of the viruses tested at different temperatures and times.
| The test virus | Test samples
(Lot No.) | Test conditions | Mean Virus Titer
(x104 PFU/mL) | Attenuation rate
(%) |
|------------------------------------------|---------------------------|-----------------|-----------------------------------|-------------------------|
| Influenza A
virus A/PR/8/34
H1N1 | 080921ES1 | 0h | 83.4 | - |
| | | 4°C, 24h | 70.5 | 15.47 |
| | | 4°C, 48h | 61.3 | 26.50 |
| | 080921ES1 | 25°C, 24h | 66.4 | 20.38 |
| | | 25°C, 48h | 44.7 | 46.40 |
| | | | | |
| Influenza A
virus A/PR/8/34
H1N1 | 040121PS | 0h | 79.2 | - |
| | | 4°C, 24h | 71.8 | 9.34 |
| | | 4°C, 48h | 63.7 | 19.57 |
| | 040121PS | 25°C, 24h | 66.9 | 15.53 |
| | | 25°C, 48h | 44.4 | 43.94 |
| | 101020E01 | 0h | 92.3 | - |
| | | 4°C, 24h | 79.1 | 14.3 |
| | | 4°C, 48h | 73.5 | 20.37 |
| | 101020E01 | 25°C, 24h | 74.3 | 19.50 |
| | | 25°C, 48h | 60.2 | 34.78 |
| Rhinovirus Type
16 | 080921ES1 | 0h | 231.7 | - |
| | | 4°C, 24h | 213.8 | 7.73 |
| | | 4°C, 48h | 204.5 | 11.74 |
| | 080921ES1 | 25°C, 24h | 168.5 | 27.28 |
| | | 25°C, 48h | 124.7 | 46.18 |
| | | | | |
| Rhinovirus Type
16 | 040121PS | 0h | 203.7 | - |
| | | 4°C, 24h | 183.4 | 9.97 |
| | 101020E01 | 4°C, 48h | 169.3 | 16.89 |
| | | 25°C, 24h | 200.2 | 1.72 |
| | | 25°C, 48h | 157.8 | 22.53 |
| | | 0h | 176.5 | - |
| | | 4°C, 24h | 169.8 | 3.80 |
| | | 4°C, 48h | 154.3 | 12.58 |
| | 101020E01 | 25°C, 24h | 114.0 | 35.41 |
| | | 25°C, 48h | 93.8 | 46.86 |
| | 080921ES1 | 0h | 26.8 | - |
| | | 4°C, 24h | 22.0 | 17.91 |
| | | 4°C, 48h | 20.0 | 25.37 |
| | | 25°C, 24h | 23.2 | 13.43 |
| | | 25°C, 48h | 21.0 | 21.64 |
| | | 0h | 31.0 | - |
| | | 4°C, 24h | 24.0 | 22.58 |
| Respiratory
syncytial virus
Type A | 040121PS | 4°C, 48h | 21.2 | 31.61 |
| | | 25°C, 24h | 24.8 | 20.00 |
| | | 25°C, 48h | 16.2 | 47.74 |
| | | 0h | 33.5 | - |
| | | 4°C, 24h | 26.3 | 21.49 |
| | | 4°C, 48h | 25.7 | 23.28 |
| | 101020E01 | 25°C, 24h | 23.8 | 28.96 |
| | | 25°C, 48h | 26.7 | 20.30 |
Table 2: Viral viability study results
8
The NEST Disposable Samplers preserved the samples of all the viruses tested for up to 48 hours at both room temperature and when refrigerated. The results confirm that the media stabilizes the target viruses meeting the performance specifications for the subject device.
Statement of Substantial Equivalence
9
Based on the indications for use, technological characteristics, safety, and performance testing, the subject device, the Disposable Sampler Viral Transport Media, meets the requirements that are considered essential for its intended use and is substantially equivalent to the legally marketed predicate device, the Copan Universal Transport Medium (UTM-RT) system, K042970.