The DNA/RNA Shield™ SafeCollection Kit is intended for the collection, inactivation, stabilization, and transportation, of unprocessed saliva specimens suspected of containing SARS-CoV-2. The DNA/RNA Shield™ SafeCollect Saliva Collection Kit is intended to transport and store saliva specimens at ambient temperature (20-25°C) from the collection site to the laboratory. Specimens collected and preserved in a DNA/RNA Shield™ Saliva Collection kit sample collection tube are suitable for use with legally marketed molecular diagnostic devices.

Device Description

The DNA/RNA Shield SafeCollect Saliva Tube consists 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 (20-25 ℃) and is intended to inactivate SARS-CoV-2, effectively lyses cells from collected saliva specimens. The DNA/RNA Shield SafeCollect Saliva Tube contains a foil seal barrier that sequesters the DNA/RNA Shield transport media inside of the tube, until the cap, with a Safe Puncture tip is used to seal the DNA/RNA Shield SafeCollect Saliva tube. When the foil seal barrier is broken by the Safe Puncture Tip, the specimen is then, and only then mixed with the DNA/RNA Shield™ transport media. The DNA/RNA Shield SafeCollect Saliva Collection Kit consists of a DNA/RNA Shield SafeCollect Saliva Tube, a funnel designed for the collection of human saliva samples, and a cap with a Safe Puncture tip. Sample collection is conducted under the supervision of a healthcare provider. The user deposits their saliva into the collection tube with the aid of the attached funnel, the user removes the funnel and replaces it with the cap. Upon twisting and closing the Safe Puncture tip cap, the DNA/RNA Shield is released into the tube and mixes with the saliva.

AI/ML Overview

The provided text describes the performance data for the DNA/RNA Shield SafeCollect Saliva Collection Kit, specifically for its ability to detect and stabilize SARS-CoV-2 in saliva specimens, and to inactivate the virus. This information is typically presented as part of a 510(k) submission to the FDA to demonstrate substantial equivalence to a predicate device.

However, the document is NOT an AI/ML medical device submission. It describes a physical medical device (a saliva collection kit) and its performance, using laboratory-based analytical studies, not an AI algorithm. Therefore, many of the requested criteria in the prompt, such as those related to AI/ML specific studies (e.g., MRMC studies, standalone algorithm performance, AI assistance effect size, training set details, expert ground truth establishment for AI/ML) are not applicable to this device.

The acceptance criteria and performance data provided are for the analytical validity of a diagnostic aid, specifically:

Detection Limit (LoD): The lowest concentration of SARS-CoV-2 that the device (in combination with a specified RT-PCR kit) can reliably detect.
Stability: How long SARS-CoV-2 RNA remains stable in the collected saliva at a specific temperature within the device.
Inactivation: The device's ability to inactivate SARS-CoV-2.

Here's an attempt to extract and present the relevant information based on the provided text, while acknowledging that many AI/ML specific criteria are not present.

Acceptance Criteria and Device Performance (Based on Analytical Studies)

Given that this document describes a physical sample collection device and not an AI/ML algorithm, the nature of "acceptance criteria" and "study" are focused on analytical performance rather than clinical or AI/ML-specific validation.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Specific Metric	Acceptance Threshold (Implicit or Explicit from Study Design)	Reported Device Performance
Detection Limit	Confirmed LoD	$\ge$ 19/20 replicates test positive at the given concentration; equivalent to authorized reference assay's LoD.	250 GEC/mL (15 GEC/rxn) with 19/20 replicates positive. Declared equivalent to the established LoD of the authorized reference assay.
Stability	Long-term (Days)	$\le$ +/- 10% deviation from Day 0 Ct values; does not exceed Day 0 by a 3-log range.	SARS-CoV-2 stable for up to 21 days at room temperature (20-25 °C). All 3/3 replicates positive at 3X LoD across all time points (Day 0, 1, 2, 3, 4, 5, 6, 7, 14, 21), with average Ct values showing minimal deviation from Day 0.
Inactivation	Viral Reduction	Demonstrates significant reduction of viral infectivity (as determined by plaque assay).	Achieved at least a 2-log reduction in SARS-CoV-2 infectivity after 30 minutes incubation at room temperature. (Note: Greater reduction could not be quantified due to necessary dilution to avoid cytotoxicity).

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

Detection Limit (LoD) Study:
- Preliminary LoD Determination: 5 replicates per concentration level.
- Confirmatory LoD Study: 20 replicates per concentration level (at and around the preliminary LoD).
- Data Provenance: Not explicitly stated, but implies laboratory-controlled spiking experiments (inactivated SARS-CoV-2 spiked into negative saliva). The data is analytical/experimental, not from patient samples.
Stability Study: 3 replicates per time point (Day 0, 1, 2, 3, 4, 5, 6, 7, 14, and 21).
Inactivation Study: Replication not explicitly stated for individual samples, but the study was "replicated three independent times" in a BSL-3 facility.

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

N/A. This is an analytical/laboratory study, not a clinical study involving human judgment or interpretation of medical images/data by experts. Ground truth is established by quantitative laboratory measurements (e.g., viral concentration, presence/absence of signal from RT-PCR, plaque formation).

4. Adjudication Method for the Test Set

N/A. As this is a laboratory-based analytical study, there is no human adjudication process involved in establishing ground truth. The results are based on objective assay readings (Ct values for PCR, plaque counts for infectivity).

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

N/A. This device is a sample collection kit, not an AI/ML algorithm that assists human readers.

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

N/A. This is a physical device, not an algorithm. Its "standalone" performance refers to its direct analytical capabilities (e.g., stabilizing RNA, inactivating virus) as measured by laboratory assays.

7. The Type of Ground Truth Used

Analytical Ground Truth:
- Detection Limit & Stability: Defined by spiking known concentrations of inactivated SARS-CoV-2 (measured in GEC/mL) into negative saliva and then performing a legally marketed molecular diagnostic test (Quick SARS-CoV-2 rRT-PCR Kit). The RT-PCR results (Ct values, positive/negative calls) serve as the ground truth against the known spiked viral load.
- Inactivation Study: Defined by the quantifiable reduction in infectious virus (plaque-forming units, PFU/mL) using a plaque assay after exposure to the collection medium, compared to an untreated control.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device that requires training data. The studies are analytical performance validation studies for a physical product.

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

N/A. No training set exists for this type of device.

Summary

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September 28, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out to the right of it.

Zymo Research Julie Ogi Regulatory Office 17062 Murphy Ave Irvine, California 92614

Re: K231013

Trade/Device Name: DNA/RNA Shield SafeCollect Saliva Collection Kit Regulation Number: 21 CFR 866.2950 Regulation Name: Microbial nucleic acid storage and stabilization device Regulatory Class: Class II Product Code: QBD Dated: August 15, 2023 Received: August 29, 2023

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 (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).

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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.

Sincerely,

Noel J. Gerald -S

Noel J. Gerald, Ph.D. Branch Chief Bacterial Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K231013

Device Name

DNA/RNA Shield™ SafeCollect Saliva Collection Kit

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Applicant	Zymo Research17062 Murphy Ave.Irvine, CA 92614USA
Establishment Registration No.	3007020052
Contact Person	Julie OgiRegulatory OfficerPhone (949) 679-1190Fax (949) 266-9452e-mail jogi@zymoresearch.com)
Summary Date	March 31, 2023
Proprietary Name	DNA/RNA Shield™ SafeCollect Saliva Collection Kit
US Product Codes / Regulation Numbers	QBD - Transport device for the stabilization of microbialnucleic acids / 21 CRF 866.2950
Classification	Class II
Predicate Device	DNA/RNA Shield™ Collection Tube(K202641)

Intended Use

The DNA/RNA Shield SafeCollect Saliva Collection Kit is intended for the collection, inactivation, stabilization, and transportation, of unprocessed saliva specimens suspected of containing SARS-CoV-2. The DNA/RNA Shield SafeCollect Saliva Collection Kit is intended to transport and store saliva specimens at ambient temperature (20-25°C) from the collection site to the laboratory. Specimens collected and preserved in a DNA/RNA Shield SafeCollect Saliva Collection kit sample collection tube are suitable for use with legally marketed molecular diagnostic devices.

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Device Description

The DNA/RNA Shield SafeCollect Saliva Tube contains a foil seal barrier that sequesters the DNA/RNA Shield transport media inside of the tube, until the cap, with a Safe Puncture tip is used to seal the DNA/RNA Shield SafeCollect Saliva tube. When the foil seal barrier is broken by the Safe Puncture Tip, the specimen is then, and only then mixed with the DNA/RNA Shield™ transport media.

The DNA/RNA Shield SafeCollect Saliva Collection Kit consists of a DNA/RNA Shield SafeCollect Saliva Tube, a funnel designed for the collection of human saliva samples, and a cap with a Safe Puncture tip. Sample collection is conducted under the supervision of a healthcare provider. The user deposits their saliva into the collection tube with the aid of the attached funnel, the user removes the funnel and replaces it with the cap. Upon twisting and closing the Safe Puncture tip cap, the DNA/RNA Shield is released into the tube and mixes with the saliva.

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Comparison to Predicate Device

Device & Predicate Device(s):	Device: K231013	Predicate K202641
Device Trade Name	DNA/RNA ShieldSafeCollect SalivaCollection Kit	DNA/RNA ShieldCollection Tube
General DeviceCharacteristic Similarities
Intended Use/Indications ForUse	The DNA/RNA ShieldSafeCollect SalivaCollection Kit is intendedfor the collection,inactivation, stabilization,and transportation, ofunprocessed salivaspecimens suspected ofcontaining SARS-CoV-2.The DNA/RNA ShieldSafeCollect SalivaCollection Kit is intendedto transport and storesaliva specimens atambient temperature (20-25°C) from the collectionsite to the laboratory.Specimens collected andpreserved in a DNA/RNAShield™ SafeCollectSaliva Collection kitsample collection tube aresuitable for use withlegally marketedmolecular diagnosticdevices.	The DNA/RNA Shieldcollection tube is intendedfor the stabilization andinactivation of upper andlower respiratory humanspecimens suspected ofcontaining SARS-CoV-2.These devices can be usedfor collection transportand storage of specimensat ambient temperatures(20-25°C). Specimenscollected and stored in aDNA/RNA Shieldcollection tube aresuitable for use withlegally marketedmolecular diagnosticdevices.
Analyte	SARS-CoV-2 RNA	Same
Sample stability	20-25°C	Same
Collection media	DNA/RNA Shield media	Same
Special conditions for use	For prescription use onlyFor in-vitro diagnostic useonly	Same
General DeviceCharacteristic Differences
Sample collection	Saliva	Upper and lowerrespiratory specimens
RNA Stabilization at roomtemperature	Saliva: up to 21 days	Upper/lower respiratorytract samples: up to 28days

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Performance data

a) Detection Limit:
An analytical sensitivity study was conducted to determine the Limit of Detection (LoD) of SARS-CoV-2 when detected in saliva samples collected using the DNA/RNA Shield SafeCollect Saliva Collection kit in combination with the authorized Quick SARS-CoV-2 rRT-PCR Kit for SARS-CoV-2 detection. To determine a preliminary LoD, SARS-CoV-2 negative saliva was used as a clinical matrix collected in DNA/RNA Shield SafeCollect Saliva Collection Kit and spiked with inactivated SARS-CoV-2. The preliminary LoD was determined as the lowest concentration for which 5/5 independent replicates tested positive. Results for the preliminary LoD determination are shown in Table 1 below.

Table 1: Preliminary LoD Determination

Concentrations Tested (GEC/mL)	Replicates	SARS-CoV-2 Targets	Interpretation	Call Rate
8.3 x 104(5,000 GEC/rxn)	1	27.33	Positive	5/5
	2	28.03	Positive
	3	27.73	Positive
	4	27.60	Positive
	5	27.73	Positive
8.3 x 103(500 GEC/rxn)	1	29.77	Positive	5/5
	2	28.83	Positive
	3	29.33	Positive
	4	29.64	Positive
	5	29.97	Positive
8.3 x 102(50 GEC/rxn)	1	32.37	Positive	5/5
	2	32.95	Positive
	3	32.31	Positive
	4	32.88	Positive
	5	32.49	Positive
83(5 GEC/rxn)	1	39.54	Positive	5/5
	2	34.16	Positive
	3	38.87	Positive
	4	32.54	Positive
	5	33.36	Positive
8.3(0.5 GEC/rxn)	1	N/A	Negative	1/5
	2	44.00	Inconclusive
	3	37.89	Positive
	4	40.94	Inconclusive
	5	N/A	Negative
Concentrations Tested (GEC/mL)	Replicates	SARS-CoV-2 Targets	Interpretation	Call Rate
250(15 GEC/ rxn)	1	34.62	Positive	19/20
	2	34.83	Positive
	3	33.99	Positive
	4	N/A	Negative
	5	35.84	Positive
	6	33.94	Positive
	7	35.25	Positive
	8	35.01	Positive
	9	33.99	Positive
	10	33.69	Positive
	11	34.01	Positive
	12	34.03	Positive
	13	35.32	Positive
	14	34.46	Positive
	15	35.84	Positive
	16	35.56	Positive
	17	33.76	Positive
	18	35.33	Positive
	19	34.00	Positive
	20	33.56	Positive
166(10 GEC/ rxn)	1	35.57	Positive	17/20
	2	35.35	Positive
	3	35.78	Positive
	4	N/A	Negative
	5	33.80	Positive
	6	34.42	Positive
	7	35.19	Positive
	8	35.01	Positive
	9	34.87	Positive
	10	36.17	Positive
	11	N/A	Negative
	12	34.25	Positive
	13	37.80	Positive
	14	N/A	Negative
	15	34.64	Positive
	16	35.44	Positive
	17	35.51	Positive
	18	35.46	Positive
	19	36.05	Positive
	20	34.66	Positive
83(5 GEC/ rxn)	1	41.48	Inconclusive	13/20
	2	37.02	Positive
	3	37.57	Positive
	4	37.07	Positive
	5	N/A	Negative
	6	36.54	Positive
	7	37.17	Positive
	8	37.25	Positive

To confirm the LoD, inactivated SARS-CoV-2 was spiked into negative saliva specimens and 20 replicates were independently processed. The lowest concentration at which all 5 replicates were positive in the preliminary LoD (i.e., 83 GEC/mL) was used as a starting point for the confirmatory LoD study. Therefore, concentrations above 83 GEC/mL (increasing by factor 2) were tested until ≥ 19/20 replicates tested positive. The final LoD for saliva was determined to be at the lowest concentration at which ≥ 19/20 replicates test positive. The final LoD was determined to be 250 GEC/mL (15 GEC/rxn). Results of the confirmatory LoD study for saliva specimens can be seen in Table 2 below.

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9	35.21	Positive
10	N/A	Negative
11	37.08	Positive
12	N/A	Negative
13	35.57	Positive
14	N/A	Negative
15	N/A	Negative
16	N/A	Negative
17	34.74	Positive
18	35.01	Positive
19	35.03	Positive
20	35.54	Positive

Conclusion:

The DNA/RNA Shield SafeCollect medium used to collect saliva, and the Authorized Quick SARS-CoV-2 2rRT-PCR Kit reached a SARS-CoV-2 LoD of 250 GEC/mL (15 GEC/reaction) for saliva specimens, which is equivalent to the established LoD of the authorized reference assay.

b) Stability of SARS-CoV-2 in saliva specimens:

The room temperature (20-25 °C) stability of SARS-CoV-2 in DNA/RNA Shield SafeCollect Saliva kit was established by spiking 3X LoD of SARS-CoV-2 (750 GEC/ml) (see LoD section above) into negative saliva specimens collected using the DNA/RNA Shield SafeCollect Saliva Collection Kit and stored at room temperature in a time course study of 21 days. The room temperature stability of SARS-CoV-2 was measured using the Quick SARS-CoV-2 rRT-PCR Kit at day 0, 1, 2, 3, 4, 5, 6, 7, 14, and 21. Results are summarized in Table 3

Concentration Tested	Days at Room Temperature	Replicates	Average Ct (Standard Deviation)	Call Rate
Low Positive3x LoD(750 GEC/mL)	Day 0	3	33.75 (0.21)	3/3
	Day 1	3	33.37 (0.22)	3/3
	Day 2	3	34.10 (0.35)	3/3
	Day 3	3	33.93 (0.32)	3/3
	Day 4	3	34.24 (0.97)	3/3
	Day 5	3	34.34 (0.24)	3/3
	Day 6	3	34.75 (0.87)	3/3
	Day 7	3	34.44 (0.41)	3/3
	Day 14	3	33.98 (0.36)	3/3
	Day 21	3	34.05 (0.48)	3/3

Table 3. SARS-CoV-2 Stability

Conclusion:

There is no significant change in stability over time and the data are within the acceptance criteria (≤+/-10% deviation from day 0). Stability is determined by acceptable data that supports the stability claim and does not exceed day 0 by a 3-log range. Therefore, SARS-CoV-2 is stable in saliva specimens collected using the DNA/RNA Shield SafeCollect Saliva Collection kit for up to 21 days when stored at room temperature (20-25 °C).

c) Inactivation:

An inactivation study was conducted to test DNA/RNA Shield SafeCollect Saliva Collection kit media ability to inactivate SARS-CoV-2. The inactivation study used a stock titer of 9x10 PFU/mL for SARS-CoV-2. The study was performed in a Biosafety Level 3 (BSL-3) facility.

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mixed with 300 uL of DNA/RNA Shield SafeCollect medium). The virus and media mixture were incubated for 30 mins at room temperature. The mixture was then serial diluted in cell culture medium and added to confluent monolavers of VeroE6 cells. Cells and media were incubated at 37°C in 5% CO2 for one hour with gentle rocking every 15 minutes. Media was aspired and 1.0 mL of pre-warmed overlay media was added. Cells were incubated for two days, fixed in 10% formaldehyde, and stained with 0.5% crystal violet to enable plaque visualization and enumeration. A positive control (untreated viral stock) and negative control (media only) were included in each run. A no-virus media control (DNA/RNA Shield media only) was also included to assess whether the media was cytotoxic. The study was replicated three independent times.

Inactivation rate:

The DNA/RNA Shield media showed no cytotoxicity on veroE6 cells when the media was diluted 1:1,000 with cell culture media. The 1:1.000 dilution factor is needed to avoid cytotoxic effects the DNA/RNA Shield media has on the cell monolayer. The mixture of SARS-CoV-2 and DNA/RNA Shield media combined for 30 minutes demonstrated at least a 2-log reduction in SARS-CoV-2. Greater than a 2-log reduction of SARS-CoV-2 could not be quantified based on the starting concentration of the virus compounded by the need to dilute the DNA/RNA Shield media 1:1000. CPE could not be observed at < 3.0 logs due to the cytotoxic effects of the DNA/RNA Shield media.

Conclusion:

Zymo DNA/RNA shield inactivates SARS-CoV2 when incubated for at least 30 minutes at room temperature.

Based on the above, Zymo Research believes that the DNA/RNA Shield Saliva Collection kit is substantially equivalent to the commercially distributed product DNA/RNA Shield Collection Tube transport, inactivation, LoD and stabilization of saliva, specimens suspected of containing SARS-CoV-2. No new issues of safety or effectiveness were found for the DNA/RNA Shield Collection Tube.

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.