(942 days)
Not Found
No
The device is a sample preservation solution and tube, which is a chemical and physical product, not a software or algorithm-based technology. The description focuses on its chemical properties, stability, and inactivation capabilities. There is no mention of AI, ML, or any computational analysis of data.
No.
This device is designed for the collection, inactivation, preservation and transport of clinical specimens for diagnostic purposes, not for treating a disease or condition.
No
Explanation: The device is a 'Sample Preservation Solution' designed for the collection, inactivation, preservation/stabilization, and transport of specimens. While the preserved samples are used with compatible molecular diagnostic assays, the solution itself does not perform a diagnostic function.
No
The device description clearly states it consists of a plastic tube filled with a liquid solution, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the solution is for the "collection, inactivation, preservation/stabilization, and transport of unprocessed upper respiratory clinical specimens" and that these specimens are "used with compatible molecular diagnostic assays." This directly relates to the preparation of samples for diagnostic testing performed outside of the body (in vitro).
- Purpose: The primary purpose of the device is to ensure the integrity of the microbial nucleic acid in the specimen so that it can be accurately detected by a subsequent diagnostic test. This is a crucial step in the in vitro diagnostic process.
- Performance Studies: The document includes performance studies such as Limit of Detection (LoD), Nucleic Acid Stability Testing, and Viral Inactivation. These are standard types of studies conducted to demonstrate the performance characteristics of an IVD device.
- Predicate Device: The mention of a predicate device (Copan eNAT Molecular Collection and Preservation Medium) with a K number (K201849) further indicates that this device is being compared to a previously cleared IVD device.
While the device itself is a sample collection and preservation solution and not the diagnostic assay itself, it is an essential component used in vitro to prepare a specimen for a diagnostic test. Therefore, it falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution is intended for the collection, inactivation, preservation/stabilization, and transport of unprocessed upper respiratory clinical specimens from individuals suspected of influenza A infection by their healthcare provider. Specimens collected with the Sample Preservation Solution can be stored and transported at 4 °C or at room temperature (20-25°C) for preservation of microbial nucleic acid until the sample is processed and used with compatible molecular diagnostic assays.
Product codes (comma separated list FDA assigned to the subject device)
QBD
Device Description
The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution consists of a plastic, polypropylene screw-cap collection tube filled with non-sterile sample preservation medium. The tubes are pre-filled with either 2 mL (suitable for swabs with flocking length of 20-24 mm) or 3 mL (suitable for swabs with flocking length of 24-30 mm) of solution. The device is nonsterile, for single use. Swabs are not included.
The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution is offered in the following configurations: YA-02 (2.0 mL/tube, 100pcs/Tray, 15 Trays/Box) and YA-03 (3.0 mL/tube, 100pcs/Tray, 15 Trays/Box).
Media Formulation:
- Guanidine isothiocyanate
- EDTA
- Tris-HC1
- Yeast RNA
- TWEEN-20
- Phenol red
- In vitro grade water
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper respiratory clinical specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare provider (implied by "individuals suspected of influenza A infection by their healthcare provider")
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 (LoD) Study:
- Study type: LoD determination for Influenza A virus.
- Sample size: Preliminary LoD determined using 5 concentrations, each tested in 4 replicates. Confirmed with 20 replicates at the preliminary LoD concentration.
- Data source: Influenza A virus (National Institutes for Food and Drug Control; Catalog numbers: 370051-201801) spiked into upper respiratory matrix.
- Key results: Preliminary LoD was 10^2 copies/mL. Confirmed by performing 20 replicates with a 100% agreement, average Ct value was 30.9 with a SD of 0.94.
Nucleic Acid Stability Testing:
- Study type: Nucleic acid stability determination for Influenza A.
- Sample size: Three (3) lots of varying ages. Triplicate samples of each lot.
- Data source: Upper respiratory samples spiked with influenza A virus (concentration of 3 x LoD).
- Key results: Samples stored at 4±1℃ for 3 and 6 days showed a decrease in Ct values of 0.43 and 2.76, respectively. Samples stored at room temperature (20-25°C) showed an increase in Ct values of 0.57 and 0.44 for 3 and 6 days, respectively, meeting the pre-defined acceptance criteria of (+/-) 3.0 Ct from the initial time zero value. The study supports Influenza A nucleic acid stability for up to 6 days at 4°C and at room temperature (20-25°C).
Viral Inactivation (Cytotoxicity):
- Study type: Cytotoxicity determination of the Sample Preservation Solution.
- Sample size: Three (3) lots at varying ages. Each sample preservation solution was serially diluted to create 2, 4, 8, 16, 32, 64, and 128-fold dilutions. Each dilution was inoculated to cell monolayers in triplicate.
- Key results: The lowest dilution to indicate normal cell growth was determined to be the 64-fold dilution.
Viral Inactivation (Viral Inactivation):
- Study type: Viral inactivation degree by the Sample Preservation Solution.
- Sample size: Three (3) lots of varying ages.
- Data source: Upper respiratory matrix in saline spiked with ≥10^7 copies per mL of influenza A virus (A/PR/8/34 H1N1).
- Key results: Influenza A viral inactivation rate was determined to be >6.2 log reduction at 5 minutes, equivalent to greater than 99.99% inactivation of Influenza A virus.
Shelf-life Stability:
- Study type: Real time aging studies for shelf-life determination.
- Sample size: Three lots of the product.
- Key results: The shelf-life was determined to be 24 months when stored at 20-25 ℃. All lots tested at various time points (0, 1, 3, 6, 12, 15, 18, 21, and 24 months) passed criteria for appearance, pH stability (pH within 7.3±0.2), and evaporation (actual volume no less than 97% of theoretical volume).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- LoD Study: 100% agreement for positive detection at 10^2 copies/mL.
- Nucleic Acid Stability: Average Ct values and ΔCt.
- Viral Inactivation: >6.2 log reduction in concentration at 5 minutes; >99.99% inactivation.
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
§ 866.2950 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 two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
April 8, 2024
Zhejiang GENE SCIENCE Co., Ltd. C/O Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Services Co.,Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006, China
Re: K212878
Trade/Device Name: Sample preservation solution Regulation Number: 21 CFR 866.2950 Regulation Name: Microbial Nucleic Acid Storage And Stabilization Device Regulatory Class: Class II Product Code: QBD Dated: September 3, 2021 Received: September 9, 2021
Dear Olivia Meng:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S
Ribhi Shawar, Ph.D. (ABMM) 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) K212878
Device Name Sample Preservation Solution
Indications for Use (Describe)
The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution is intended for the collection, inactivation, preservation/stabilization, and transport of unprocessed upper respiratory clinical specimens from individuals suspected of influenza A infection by their healthcare provider. Specimens collected with the Sample Preservation Solution can be stored and transported at 4 °C or at room temperature (20-25°C) for preservation of microbial nucleic acid until the sample is processed and used with compatible molecular diagnostic 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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3
510(k) Summary - K212878
April 8, 2024
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
| Submitted by: | Zhejiang GENE SCIENCE Co., Ltd
No.2 workshop, Pharmaceutical Industrial Park, No.11
Shengxing Road, Shangyu Economic and Technological
Development zone Hangzhou Bay, Zhejiang Province, China
Tel: +86-575-82586086
E-mail: support@gene-science-tech.com
Website: http://www.gene-science-tech.com/ |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Olivia Meng
Zhejiang GENE SCIENCE Co., Ltd.
Tel: +86-188-25133860,
Email: hui.meng@osmundacn.com |
| Name of Device: | Sample Preservation Solution |
| Classification Name: | Microbial Nucleic Acid Storage and Stabilization Device |
| Regulatory Class: | Class II |
| Product Code: | QBD |
| Regulation: | 21 CFR 866.2950 |
| Predicate Device: | Copan eNAT Molecular Collection and Preservation Medium
(K201849) Manufacturer: Copan Diagnostics Inc. |
1. Intended Use/Indication for Use
The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution is intended for the collection, inactivation, preservation/stabilization, and transport of unprocessed upper respiratory clinical specimens from individuals suspected of influenza A infection by their healthcare provider. Specimens collected with the Sample Preservation Solution can be stored and transported at 4 °C or at room temperature (20-25°C) for preservation of microbial nucleic acid until the sample is processed and used with compatible molecular diagnostic assays.
2. Device Description
The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution consists of a plastic, polypropylene screw-cap collection tube filled with non-sterile sample preservation medium. The tubes are pre-filled with either 2 mL (suitable for swabs with flocking length of 20-24 mm) or 3 mL (suitable for swabs with flocking length of 24-30 mm) of solution. The device is nonsterile, for single use. Swabs are not included.
The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution is offered in the following configurations:
4
| SKU or Catalog Number | Device Description | Pack Size |
|---|---|---|
| YA-02 | 2.0 mL/tube | 100pcs/Tray, 15 Trays/Box |
| YA-03 | 3.0 mL/tube | 100pcs/Tray, 15 Trays/Box |
Media Formulation:
- Guanidine isothiocyanate
- EDTA
- Tris-HC1 ●
- Yeast RNA
- TWEEN-20
- Phenol red
- In vitro grade water
3. Principles of Operation
The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution consists of the following: Guanidine isothiocyanate, EDTA, Tris-HCl, Yeast RNA, TWEEN-20, Phenol red and in vitro diagnostic grade water. The guanidine isothiocyanate lyses cells, denatures proteins, and inhibits nuclease activity, thereby stabilizes nucleic acids. EDTA is a chelating agent that deactivates RNAse and stabilizes RNA. Tris-HCl is a pH buffer system to maintain reagent pH. Yeast RNA serves as a blocking agent, protects RNA, helps coprecipitating microbial nucleic acid. TWEEN-20 is a detergent that disrupts membranes and denatures proteins. Phenol red is a pH indicator which serves as a visual quality control mechanism. The in vitro diagnostic grade water serves as a diluent to adjust molarity of the buffer/preservation medium.
4. Substantial Equivalence
The Zhejiang GENE SCIENCE Co., Ltd. Sample Preservation Solution is compared with the predicate device, Copan eNAT Molecular Collection and Preservation Medium (K201849). , in intended use, medium formulation, product configuration, shelf life, packaging and volume, etc. The safety and effectiveness of the Zhejiang GENE SCIENCE Co., Ltd. Sample Preservation Solution is adequately supported by the substantial equivalence information and testing results provided. Below is a summary of comparison table between Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution and predicate device K201849:
| Device & Predicate
Device(s): | Subject Device:
K212878 | Predicate:
K201849 |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | Sample Preservation
Solution | Copan eNAT Molecular
Collection and
Preservation Medium |
| General Device
Characteristic Similarities | | |
| Indications For Use | The Zhejiang GENE
SCIENCE Co., Ltd.'s
Sample Preservation
Solution is intended for
the collection.
inactivation,
preservation/stabilizatio
n, and transport of
unprocessed upper
respiratory clinical
specimens from
individuals suspected of
influenza A infection by
their healthcare
provider. Specimens
collected with the
Sample Preservation
Solution can be stored
and transported at 4°C
or at room temperature
(20-25°C) for
preservation of
microbial nucleic acid
until the sample is
processed and used with
compatible molecular
diagnostic assays. | Copan eNAT is
intended for the
collection, inactivation
and transport of clinical
specimens containing
influenza A viruses
from the collection site
to the testing laboratory.
eNAT can be processed
and used with
compatible molecular
assays that require
stabilization of nucleic
acids from influenza A
viruses. |
| Microorganism nucleic
acids preserved | Influenza A virus | Same |
| Specimen Type | Upper respiratory
specimens | Same |
| General Device
Characteristic Differences | | |
| Specimen stability | Preserves influenza A
RNA for up to 6 days at
4-25 °C | Preserves influenza A
RNA for up to 28 days
at 2-25°C |
| | | |
| Ingredients | Guanidine
isothiocyanate | Tris-EDTA |
| | EDTA | Guanidine thiocyanate |
| | Tris-HCl | Detergent |
| | Yeast RNA | HEPES |
| | TWEEN-20 | Distilled water |
| | Phenol red | |
| | In Vitro Diagnostic
grade water | |
| | | |
| Inactivation of Flu A | >6.2 log reduction in
concentration at 5
minutes | >4.0 log reduction in
concentration at 10
seconds |
| Configurations of device | 2mL or 3mL | 2mL with either no
swab, regular sized tip
nylon flocked swab or
minitip nylon flocked
swab. |
| | | |
| | | |
| Shelf-life | 24 months | 18 months |
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5. Shelf-life Stability
The shelf-life of the Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution was determined to be 24 months from the date of manufacture when stored at 20-25 ℃.
Three lots of the product were assessed for functionality and physical characteristics using real time ageing studies. In the real time study, the Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solutions were held at 20-25 ℃ for 24 months (T= 0, 1, 3, 6, 12, 15, 18, 21, and 24). At each time point, appearance, pH and loading volume were assessed for each product lot in triplicate.
-
a) Appearance
To evaluate appearance, the different lots of the Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution were visually examined. The appearance of the product was examined for a good seal of the packaging, no damage, leakage, or deformation; the label was clean, clear, and complete; the color of the reagent was consistent with no precipitation or impurities. All lots tested at each time point passed the criteria for appearance when held at 20-25°C. -
b) pH Stability
The pH of the media was used as one of the indicators to support product stability. For all the tubes at each time point and each lot, the pH was within the targeted range of 7.3±0.2 when held at 20-25°C.
7
- c) Evaporation
To evaluate evaporation, the loading volume for the different lots of the Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution were measured. All lots tested at each time point passed the criteria for evaporation (up to >97% of loading volume) when held at 20-25°C.
The Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution results after 24 months of storage showed that the actual volume was no less than 97% of the theoretical volume, the appearance was acceptable, and the pH was 7.3+ 0.2. There was no leakage or deformation, showing that the product met quality standards.
6. Performance Data
Limit of Detection (LoD) Study:
The limit of detection (LoD) for the Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution (3mL/tube) was determined by spiking Influenza A virus (National Institutes for Food and Drug Control; Catalog numbers: 370051-201801) at a starting concentration of ≥ 1 x 107 copies/mL into upper respiratory matrix and inoculated into Sample Preservation Solution for a final concentration of 1 x 10° copies/mL. The spiked sample was then serially diluted in negative upper respiratory matrix to create five (5) concentrations (10°, 10°, 10° and 10 copies/mL). Each concentration was tested in four (4) replicates. Samples were extracted with the Oiagen RNeasy Mini Kit and RT-PCR was performed using the Invitrogen SuperScript III Platinum One-Step Quantitative Kit on the ThermoFisher ABI 7500 Instrument. The preliminary LoD was determined to be 102 copies/mL and confirmed by performing 20 replicates with a 100% agreement, average Ct value was 30.9 with a SD of 0.94. (Table 1-2).
| ThermoFisher
ABI 7500
Instrument | Concentration (cp/mL)
(Ct 6.2 log reduction at 5 minutes which was equivalent to greater than 99.99% inactivation of Influenza A virus (Table 4).
Inactivation (log reduction): Mv = log (C0/Ct) = log(C0)-log (Ct)
| Time
| (min) | Inactivation (log reduction, Mv) | ||
|---|---|---|---|
| Lot#1 | Lot#2 | Lot#3 | |
| 0 | >6.97 | >6.97 | 3.28 |
| 5 | >6.20 | >6.20 | >6.20 |
| 10 | >6.75 | >6.75 | >6.75 |
Table 4: Influenza A Viral Inactivation in Sample Preservation Solution
Conclusion:
Zhejiang GENE SCIENCE Co., Ltd's. Sample Preservation Solution inactivates Influenza A virus when incubated for at least 5 minutes.
7. Final Conclusion
Based on the indications for use, technological characteristics, safety, and performance testing, the subject device, the Zhejiang GENE SCIENCE Co., Ltd.'s Sample Preservation Solution, meets the requirements that are considered essential for its intended use and is substantially equivalent to the legally marketed predicate device, Copan eNAT Molecular Collection and Preservation Medium, K201849.