(94 days)
PrimeStore MTM (DEN170029)
No
The 510(k) summary describes a collection tube and transport media for stabilizing and inactivating biological specimens. There is no mention of AI or ML in the intended use, device description, performance studies, or any other section. The technology described is purely chemical and biological for sample preservation.
No
The device is described as a collection tube for the stabilization and inactivation of specimens suspected of containing SARS-CoV-2, which are then used with molecular diagnostic devices. It is for "in vitro diagnostic use only," indicating it is used to analyze samples outside of the body for diagnosis, not to treat a condition within the body.
No
This device is a collection tube intended for the stabilization and inactivation of specimens. It is designed to prepare specimens for use with "legally marketed molecular diagnostic devices," but it is not a diagnostic device itself.
No
The device description clearly states it consists of a tube pre-filled with transport media and may be kitted with a swab or sputum collection kit, indicating it is a physical device with chemical components, not software only.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "stabilization and inactivation of upper and lower respiratory human specimens suspected of containing SARS-CoV-2" and that specimens collected are "suitable for use with legally marketed molecular diagnostic devices." This indicates its role in the diagnostic process.
- Intended User / Care Setting: It clearly states "For in vitro diagnostic use only."
- Performance Studies: The document includes performance studies like "Limit of detection study" and "Specimen Stability study," which are typical for IVD devices to demonstrate their analytical performance.
- Predicate Device: It lists a predicate device (DEN170029; PrimeStore MTM), which is a common practice for demonstrating substantial equivalence for IVD devices seeking regulatory clearance.
Therefore, all these factors strongly indicate that the DNA/RNA Shield™ collection tube is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DNA/RNA Shield™ collection tube is intended for the stabilization and inactivation of upper and lower respiratory human specimens suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens at ambient temperatures (20-25°C). Specimens collected and stored in a DNA/RNA Shield™ collection tube are suitable for use with legally marketed molecular diagnostic devices.
Product codes
QBD
Device Description
The DNA/RNA Shield™ collection tube and reagent consist of a tube pre-filled with DNA/RNA Shield™ transport media. DNA/RNA Shield™ is a transport media that ensures stability of SARS-CoV-2 RNA during sample transport/storage at ambient temperatures and is intended to inactivate SARS-CoV-2, effectively lyses cells from collected upper and lower respiratory biological specimens. The DNA/RNA Shield™ transport media may be kitted with a swab, sputum collection kit or as a tube alone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower respiratory human specimens
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)
Inactivation: An inactivation study was conducted to verify that DNA/RNA Shield inactivates SARS-CoV-2 virus as efficiently as other legally marketed devices. High concentrations of SARS-CoV-2 virus (9x10^6 PFU) were inoculated into DNA/RNA Shield. The viability of the virus was measured after 30 min in DNA/RNA Shield medium by inoculating aliquots onto veroE6 cells, incubating for two days and measuring the cytopathic effect (CPE). The results for the inactivation study indicated a CPE of 2.0 log reduction in viral titer after a 30 min exposure and demonstrates equivalent performance of DNA/RNA Shield with PrimeStore MTM™ for inactivation.
Limit of detection: An analytical sensitivity study was conducted to determine the SARS-CoV-2 Limit of Detection (LoD) obtained by DNA/RNA Shield in combination with the Quick SARS-CoV-2 rRT-PCR Kit. The RNA was spiked into DNA/RNA Shield medium then samples were extracted using the Quick-DNA/RNA Viral MagBead kit performed on the KingFisher™ Flex Purification System and then amplified using the Authorized Quick SARS-CoV-2 rRT-PCR Kit. The DNA/RNA Shield reached an LoD of 250 GEC/mL (15 GEC/reaction) for sputum and oral swab.
Specimen Stability: A stability study was designed to demonstrate that SARS-CoV-2 RNA from sputum and oral swab was preserved and stabilized in DNA/RNA Shield media. The stability studies used contrived specimens with sample matrices and SARS-CoV-2 RNA spiked into DNA/RNA Shield. The specimens were then amplified using the Quick SARS-CoV-2 rRT-PCR Kit. The results of SARS-CoV-2 RNA stability study confirmed that RNA stabilized in DNA/RNA Shield met the acceptance criteria of +/- 3.0 Ct after 4 weeks storage at 20 - 25 °C. This study demonstrates equivalent performance of DNA/RNA Shield with the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
LoD of 250 GEC/mL (15 GEC/reaction) for sputum and oral swab.
RNA stabilized in DNA/RNA Shield met the acceptance criteria of +/- 3.0 Ct after 4 weeks storage at 20 - 25 °C.
Predicate Device(s)
PrimeStore MTM (DEN170029)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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December 14, 2020
Zymo Research Julie Ogi Regulatory Officer 17062 Murphy Ave. Irvine, California 92614
Re: K202641
Trade/Device Name: DNA/RNA Shield Collection Tube Regulation Number: 21 CFR 866.2950 Regulation Name: Microbial Nucleic Acid Storage and Stabilization Device Regulatory Class: Class II Product Code: QBD Dated: September 8, 2020 Received: September 11, 2020
Dear Julie Ogi:
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 probibitions 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
1
801 and Part 809); medical device reporting (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 531-542 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-devices/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 (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,
Kristian Roth, Ph.D. Branch Chief Bacterial Respiratory and Medical Countermeasures 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
2
Indications for Use
510(k) Number (if known)
Device Name
DNA/RNA Shield Collection Tube
Indications for Use (Describe)
The DNA/RNA Shield™ collection tube is intended for the stabilization and inactivation of upper and lower respiratory human specimens suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens at ambient temperatures (20-25°C). Specimens collected in a DNA/RNA Shield™ collection tube are suitable for use with legally marketed molecular diagnostic devices.
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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| Applicant | Zymo Research
17062 Murphy Ave.
Irvine, CA 92614
USA |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration No. | Pending / User Fees Paid |
| Contact Person | Julie Ogi
Regulatory Officer
Phone (949) 679-1190
Fax (949) 266-9452
e-mail jogi@zymoresearch.com |
| Summary Date | September 8, 2020 |
| Proprietary Name | DNA/RNA Shield™ collection tube |
| Common name | DNA/RNA Shield |
| Device | Transport device for the stabilization of microbial
nucleic acids |
| Product Codes/Regulation Numbers | QBD - Transport device for the stabilization of
microbial nucleic acids / 21 CRF 866.2950 |
| Classification | Class II |
| Review Panel | Microbiology 83 |
| Predicate Devices | PrimeStore MTM (DEN170029) |
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Image /page/4/Picture/0 description: The image shows the logo for Zymo Research. The logo consists of three green oval shapes arranged in a triangular pattern. Each oval shape contains two smaller circles inside. Below the shapes, the words "ZYMO RESEARCH" are written in a bold, sans-serif font. Underneath the company name is the text "The Beauty of Science is to Make Things Simple".
Intended Use
The DNA/RNA Shield™ collection tube is intended for the stabilization and inactivation of upper and lower respiratory human specimens suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens at ambient temperatures (20-25°C). Specimens collected and stored in a DNA/RNA Shield™ collection tube are suitable for use with legally marketed molecular diagnostic devices.
Device Description
The DNA/RNA Shield™ collection tube and reagent consist of a tube pre-filled with DNA/RNA Shield™ transport media. DNA/RNA Shield™ is a transport media that ensures stability of SARS-CoV-2 RNA during sample transport/storage at ambient temperatures and is intended to inactivate SARS-CoV-2, effectively lyses cells from collected upper and lower respiratory biological specimens. The DNA/RNA Shield™ transport media may be kitted with a swab, sputum collection kit or as a tube alone.
Comparison to Predicate Device
| Similarities | ||
|---|---|---|
| Item | Predicate Device: | |
| PrimeStore MTM (DEN170029) | Proposed Device: | |
| DNA/RNA Shield™ collection | ||
| tube and reagent | ||
| Intended Use | PrimeStore MTM is a device | |
| intended for the stabilization, | ||
| transportation and inactivation of | ||
| infectious unprocessed nasal | ||
| washes suspected of containing | ||
| Influenza A (Flu A) virus RNA or | ||
| unprocessed sputum samples | ||
| suspected of containing | ||
| Mycobacteriumtuberculosis (MTB) | ||
| DNA from human samples. | ||
| Transport device can transport and | ||
| store specimens between 36-77 °F | ||
| (2-25 °C). | The DNA/RNA Shield™ collection | |
| tube is intended for the stabilization | ||
| and inactivation of upper and lower | ||
| respiratory human specimens | ||
| suspected of containing SARS- | ||
| CoV-2. These devices can be used | ||
| for collection transport and storage | ||
| of specimens at ambient | ||
| temperatures (20-25°C). Specimens | ||
| collected and stored in a | ||
| DNA/RNA Shield™ collection tube | ||
| are suitable for use with legally | ||
| marketed molecular diagnostic | ||
| devices. | ||
| Special conditions for | ||
| use | 1. For in vitro diagnostic use only |
- For prescription use only | 1. For in vitro diagnostic use only
- For prescription use only |
| DNA/RNA stabilization
at ambient
temperature | 28 days: MTB
8 days: Flu A | ≤28 days sputum and OP |
| Sample source | Human respiratory | Human respiratory |
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| Differences | ||
|---|---|---|
| Item | Predicate Device: | |
| PrimeStore MTM(DEN170029) | Proposed Device: | |
| DNA/RNA Shield™ collection tube | ||
| and reagent | ||
| RNA stabilizationat | ||
| refrigeration | ≤8 days flu | |
| ≤36 days MTB | no refrigeration claims | |
| Analyte | DNA, RNA | RNA |
| Sample collection | Nasal wash suspected of | |
| containing Influenza A virus. | ||
| Sputum samples suspected of | ||
| containing MTB. | Lower and Upper Respiratory | |
| Specimens for SARS-CoV-2. |
Performance data:
Inactivation
An inactivation study was conducted to verify that DNA/RNA Shield inactivates SARS-CoV-2 virus as efficiently as other legally marketed devices.
High concentrations of SARS-CoV-2 virus (9x106 PFU) were inoculated into DNA/RNA Shield. The viability of the virus was measured after 30 min in DNA/RNA Shield medium by inoculating aliquots onto veroE6 cells, incubating for two days and measuring the cytopathic effect (CPE).
The results for the inactivation study indicated a CPE of 2.0 log reduction in viral titer after a 30 min exposure and demonstrates equivalent performance of DNA/RNA Shield with PrimeStore MTM™ for inactivation.
Limit of detection
An analytical sensitivity study was conducted to determine the SARS-CoV-2 Limit of Detection (LoD) obtained by DNA/RNA Shield in combination with the Quick SARS-CoV-2 rRT-PCR Kit. The RNA was spiked into DNA/RNA Shield medium then samples were extracted using the Quick-DNA/RNA Viral MagBead kit performed on the KingFisher™ Flex Purification System and then amplified using the Authorized Quick SARS-CoV-2 rRT-PCR Kit. The DNA/RNA Shield reached an LoD of 250 GEC/mL (15 GEC/reaction) for sputum and oral swab.
Specimen Stability
A stability study was designed to demonstrate that SARS-CoV-2 RNA from sputum and oral swab was preserved and stabilized in DNA/RNA Shield media. The stability studies used contrived specimens with sample matrices and SARS-CoV-2 RNA spiked into DNA/RNA Shield. The specimens were then amplified using the Quick SARS-CoV-2 rRT-PCR Kit. The results of SARS-CoV-2 RNA stability study confirmed that RNA stabilized in DNA/RNA Shield met the acceptance criteria of +/- 3.0 Ct after 4 weeks storage at 20 - 25 °C. This study demonstrates equivalent performance of DNA/RNA Shield with the legally marketed predicate device.
6
Image /page/6/Picture/0 description: The image shows the logo for Zymo Research. The logo consists of three green oval shapes arranged in a triangular pattern. Below the shapes, the words "ZYMO RESEARCH" are written in bold, black letters. Underneath the company name is the tagline "The Beauty of Science is to Make Things Simple."
Based on the above, Zymo Research believes that the DNA/RNA Shield collection tube is substantially equivalent to the legally marketed predicate device for the inactivation, LoD and stabilization of specimens containing SARS-CoV-2 for collection, stabilization and recovery. No new issues of safety or effectiveness were found for the DNA/RNA Shield collection tube.