The Spectrum Solutions Saliva Collection Device is designed for use in the non-invasive collection, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples. The device is intended to inactivate and stabilize human clinical saliva samples from the collection site to the laboratory at room temperature. The saliva sample is stabilized and suitable for use with legally marketed molecular diagnostic device is intended to be used by a health care provider for samples suspected of containing SARS-CoV-2.

Device Description

The Spectrum Solutions Saliva Collection device consists of a plastic tube designed for the collection of human saliva samples, a funnel, a cap with a stem flare, and a fluid chamber containing Spectrum's inactivating media. Sample collection is conducted under the supervision of a Health care provide. 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 cap, the stabilizing solution is released into the tube and mixed with the saliva.

AI/ML Overview

The Spectrum Solutions Saliva Collection Device is a microbial nucleic acid storage and stabilization device designed for the non-invasive collection, inactivation, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples, specifically for SARS-CoV-2.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Reference
Limit of Detection (LoD)	Greater than 95% accuracy for detecting 2/3 gene targets (ORF1ab, N gene, S gene) from SARS-CoV-2.	20 GEC/reaction demonstrated 20/20 replicates (100% accuracy) for amplification of ORF1ab and N gene. (This is equivalent to 250 GEC/ml).	Confirmatory LoD testing (Table 2)
Sample Stability	1. TaqPath COVID-19 assay detects 3 targets (Orf1ab, N gene, and S gene). A sample is considered positive if at least 2 of the 3 targets are amplified with Ct values <37.	All 44 samples tested positive for SARS-CoV-2 at all time points (0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 days), with one initial inconclusive result becoming positive upon retesting.	Stability study results (Tables 4 & 5)
	2. Stability is based upon a variance of no more than +/- 3 Ct for each target at a given time point from T=0.	Minimal Ct changes over 28 days. Highest variance for N gene was 2.71, which is within the +/- 3 Ct criteria.	Stability study results (Table 5)
Viral Inactivation	1. At least a 4 log10 of TCID50 would be recovered from the virus control.	Virus control showed 6.50 TCID50 (Log10).	Viral Inactivation Summary (Table 6)
	2. At least a 3 log10 reduction in titer could be demonstrated beyond the cytotoxic level.	Greater than 4.00 log10 reduction in SARS-CoV-2 following 10-second and 60-minute exposures.	Viral Inactivation Summary (Table 6)
	3. Spectrum inactivating media was fully neutralized after the timed exposure such that the difference in virus titer for the Neutralization Control, Neutralization Toxicity Control, and Virus Control did not exceed 1.0 log10.	Neutralization Control (5.75) and Neutralizer Toxicity Control (6.00) were within 1.0 log10 difference from Virus Control (6.50).	Viral Inactivation Summary (Table 6)

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

Limit of Detection (LoD):
- Preliminary LoD: 5 samples per concentration (total of 7 concentrations tested: 0, 10, 20, 50, 100, 250, 500 GEC/reaction).
- Confirmatory LoD: 20 replicate samples for each of 15 GEC/reaction and 20 GEC/reaction concentrations (total of 40 samples).
Sample Stability: 4 contrived samples (from two different device lots, each collecting two samples).
Viral Inactivation: Not explicitly stated as a "test set" in the context of clinical samples, but the experiment involved 3 different lots of devices, with each test performed in two replicates per device, and plating of each replicate performed four times. The analysis appears to be based on laboratory-contrived samples.
Data Provenance: The studies appear to be laboratory-based performance studies using contrived samples. The data provenance is not specified regarding country of origin or whether it's retrospective or prospective, but given the nature of the tests (LoD, stability, inactivation), they are typically prospective, controlled laboratory studies. The "clinically negative matrix (saliva)" and "single negative donor" indicate the use of human biological material, but the primary focus is on the device's interaction with spiked viral loads.

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

The ground truth for these performance studies (LoD, stability, inactivation) is established by the known concentration of spiked SARS-CoV-2 (for LoD and stability) and the measured viral reduction (for inactivation). This is an objective measurement based on laboratory methods (RT-PCR and TCID50 assays), not clinical expert consensus. Therefore, the concept of "experts used to establish the ground truth" in the diagnostic interpretation sense does not apply here. The protocols and interpretation of results would be overseen by qualified laboratory personnel and study directors.

4. Adjudication Method for the Test Set:

Adjudication methods like 2+1, 3+1 are typically used in clinical studies where human readers or diagnosticians interpret images or clinical data. In these laboratory performance studies, the results are objectively measured (e.g., Ct values, log reduction) against pre-defined quantitative acceptance criteria. Discrepancies would likely be resolved through re-testing or investigation of methods, rather than clinical adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. This device is a saliva collection and stabilization device, not an AI-powered diagnostic imaging tool or a device requiring human interpretation in the context of an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The concept of "standalone performance" typically refers to the algorithmic performance of an AI-driven device. This is not applicable to the Spectrum Saliva Collection Device, as it is a physical medical device for sample collection and stabilization, not an algorithm. The performance evaluated here is the device's ability to maintain the integrity and detectability of viral nucleic acids.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The ground truth used in these studies is primarily known contrived samples with specific concentrations of SARS-CoV-2 (molecular ground truth).
- For LoD and stability, the ground truth is the intentionally spiked SARS-CoV-2 GEC/reaction.
- For inactivation, the ground truth is the initial known concentration of live virus and the subsequent measured reduction in viral infectivity.

8. The Sample Size for the Training Set:

This device is not an AI/machine learning model, so there is no "training set" in the conventional sense. The studies described are performance validation studies for a physical product.

9. How the Ground Truth for the Training Set Was Established:

As there is no training set for an AI/machine learning model, this question is not applicable. The establishment of ground truth for the performance studies involved meticulous laboratory preparation of known viral concentrations in a saliva matrix.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Spectrum Solutions, LLC Katie Compton Vice President of Quality Assurance and Regulatory Affairs 12248 South Lone Peak Pkwy. Ste 106 Draper. Utah 84020

February 17, 2023

Re: K223497

Trade/Device Name: Spectrum Saliva Collection Device Regulation Number: 21 CFR 866.2950 Regulation Name: Microbial Nucleic Acid Storage And Stabilization Device Regulatory Class: Class II Product Code: QBD Dated: November 18, 2022 Received: November 21, 2022

Dear Katie Compton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 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,

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name Saliva Collection

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) SUMMARY

Submitter's Name and Address:

Spectrum Solutions 12248 S. Lone Peak Parkway, Ste 106 Draper, UT 84020

Contact Name and Information:

Katie Compton VP of Quality Assurance and Regulatory Affairs Spectrum Solutions, LLC. 801- 569-0465 x215 (office) 801-719-8558 (cell) Katie@spectrumsolution.com

Date prepared:

November 18, 2022

Device Information:

Trade/Proprietary Name:	Spectrum Solutions Saliva Collection Device
Common or Usual Name:	SDNA 1000
Classification Name:	Microbial nucleic acid storage and stabilization device
Classification Number:	Class II, 21 CFR 866.2950
Product Code:	OBD

Predicate Device:

510(k) Number	Device	Manufacturer
K202641	DNA/RNA Shield Collection Tube	ZYMO Research

Device Description:

Indications for Use/Intended Use:

The Spectrum Solutions Saliva Collection Device is designed for use in the non-invasive collection, inactivation, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples. The device is intended to inactivate and stabilize human clinical saliva samples from the collection site to the laboratory at room temperature. The saliva sample is stabilized and suitable for use with legally marketed molecular diagnostic devices. The device is intended to be used by a health care provider for samples suspected of containing SARS-CoV-2.

{4}------------------------------------------------

Technological Characteristics:

The proposed device shares the same technological characteristics found in the predicate device and other cleared saliva collection devices on the market.

Feature:	Device: K223497	Predicate: K202641
Device Trade Name	Spectrum Solutions SalivaCollection Device	DNA/RNA Shield Collection Tube
General Device CharacteristicSimilarities
Intended Use/Indications ForUse	The Spectrum Solutions SalivaCollection Device is designedfor use in the non-invasivecollection, inactivation, andstabilization of viral nucleicacids for in vitro diagnostictesting of saliva samples. Thedevice is intended to inactivateand stabilize human clinicalsaliva samples from thecollection site to the laboratoryat room temperature. Thesaliva sample is stabilized andsuitable for use with legallymarketed molecular diagnosticdevices. The device is intendedto be used by a health careprovider for samples suspectedof containing SARS-CoV-2.	The DNA/RNA Shield collectiontube is intended for thestabilization and inactivation ofupper and lower respiratoryhuman specimens suspected ofcontaining SARS-CoV-2. Thesedevices can be used forcollection transport and storageof specimens at ambienttemperatures (20-25°C).Specimens collected and storedin a DNA/RNA Shield™ collectiontube are suitable for use withlegally marketed moleculardiagnostic devices.
Additive/Reagent	Nucleic Acid Stabilizationsolution	Same
Analyte	RNA from SARS-CoV-2	Same
Limit of Detection	250 GEC/ml (20 GEC/reaction)	Same
Specimen Stability	SARS-CoV-2 for 28 days at 20-25 °C	Same
Transport Media	Disrupt/lyses lipid membranes,inactivates enzymes, andstabilizes nucleic acids	Same
Material	Medical-grade polypropylene	Same
Sterility	Non-Sterile	Same
General Device CharacteristicDifferences
Specimen Type	Saliva only	Upper, lower respiratory, andsaliva
Device Material	Tube - Polypropylene FunnelPolypropyleneCap - Polypropylene & HDPE	Plastic Collection Tube pre-filledwith DNA/RNA Shield transportmedia

{5}------------------------------------------------

	Spectrum's Nucleic AcidStabilization Solution
Inactivation test	Greater than 4 Log viralreduction in 10 seconds	Greater than 2 log viralreduction in 30 minutes

The Spectrum Solutions Saliva Collection Device is substantially equivalent to the legally marketed predicate device. The Spectrum Solutions Saliva Collection Device has the same intended use and similar indications for use, technological characteristics, and principles of operation as its predicate device. Performance data demonstrates that the Spectrum Solutions Saliva Collection Device is as safe and effective.

Based on the technical characteristics and the results of the performance testing, the Spectrum Solutions Saliva Collection Device is substantially equivalent to the predicate.

Performance Data:

Detection Limit

a) Limit of Detection (LoD) testing was conducted to determine the lowest concentration of whole genome (Genome Equivalent Copies; GEC) that contains measurable nucleic acids that can be repeatedly recovered from the transport media with greater than 95% accuracy. LoD was obtained by spiking the Spectrum SDNA-1000 collection device containing negative matrix (saliva + preservative) with various concentrations of SARS-CoV-2 before RNA samples were extracted using the MagMAX Viral/Pathogen II (MVP II) Nucleic Acid Isolation Kit performed with the KingFisher Flex Purification System and then amplifying using the TaqPath COVID-19 Combo Kit using the Applied Biosystems QuantStudio 5 (QS5) Fast Real-Time PCR System. The RNA extraction and RT-PCR kits contained an internal MS2 Phage control to monitor the integrity of nucleic acid extraction and RT-PCR for each specimen. Ct values and detection of virus were determined using the EUA IFU guidelines and the Applied Biosystems COVID-19 Interpretative Software v2.5.
Acceptance criteria for RT-PCR reactions: For the COVID-19 TaqPath assay, Ct values <37 are considered positive for SARS-CoV-2. Ct values of 37 to <40 were considered inconclusive and those samples retested to determine SARS-CoV-2 status, as per the protocol Qualitative Detection of Nucleic Acid from SARS-CoV-2 using the COVID-19 TaqPath Combo Kit (JB-PRO-000105, v.2.1). Three gene targets in SARS-CoV-2 were subjected to amplification (ORF1ab, N gene, and S gene), with a sample considered positive if 2/3 of these gene targets were amplified.
b) Preliminary LoD testing was initially performed by spiking multiple concentrations of SARS-CoV-2 GEC into clinically negative matrix (saliva) to achieve final concentrations of 0, 10, 20, 50, 100, 250, and 500 GEC/reaction. Five samples of each of these contrived concentrations were tested with results shown below in Table 1.

{6}------------------------------------------------

GEC/reaction	Orf1abdetection	ORF1aMean Ct	N genedetection	N geneMean Ct	S genedetection	S geneMean Ct	SARS-CoV-2positiveresult
0	0/5	ND	0/5	ND	0/5	ND	0/5
10	5/5	34.45	0/5	ND	0/5	ND	5/5
20	5/5	32.89	5/5	33.97	0/5	ND	5/5
50	5/5	31.81	5/5	31.90	5/5	33.45	5/5
100	5/5	30.43	5/5	30.30	5/5	31.66	5/5
250	5/5	29.44	5/5	29.06	5/5	30.13	5/5
500	5/5	29.05	5/5	28.84	5/5	29.67	5/5

Table 1. Preliminary LoD results (preliminary LoD highlighted) 5 samples tested/concentrations:

The presumptive LoD based on the preliminary results was 20 GEC/reaction, but preliminary results with the 10 GEC/reaction showed that one of the three gene targets was amplified (ORF1ab). Therefore, it was possible that 15 GEC/reaction was a better LoD estimate. Therefore, both 15 and 20 GEC/reactions were each included in a set of 20 samples for confirmatory analysis of LoD (see Table 2). A positive result for a sample was defined as amplification of at least 2 of the 3 gene targets from SARS-CoV-2 (ORF1ab, N gene, S gene) per the IFU from the authorized device.

Confirmatory testing supported an LoD of 20 GEC/reaction with 20/20 replicates for amplification of ORF1ab and 20/20 replicates for N gene, which met the pre-defined criteria for RT-PCR reactions (greater than 95% accuracy for detecting 2/3 targets in samples). However, with 15 GEC/reaction, only 16/20 samples met the requirement of 2/3 targets amplified (80% accuracy), which fell below the pre-defined criteria. Therefore, 20 GEC/reaction is the established LoD.

GEC/reaction	Orf1abdetection	ORF1aMean Ct	N genedetection	N geneMean Ct	S genedetection	S geneMean Ct	SARS-CoV-2positiveresult
15	20/20	33.92	16/20	35.29	0/20	ND	0/5
20	20/20	33.81	20/20	35.23	2/20	36.77	5/5

Table 2. Confirmatory LoD results 20 samples tested/concentrations:

Ct values for each of the three amplified genes of the 20 replicates of the confirmatory tests for the 20 GEC/reaction concentration are shown in Table 3.

{7}------------------------------------------------

	Ct Value
Replicate	ORF1ab	N gene	S gene
1	36.14	34.83
2	33.09	35.84
3	33.35	36.09
4	30.03	36.79
5	34.50	34.48
6	32.18	36.48
7	34.60	34.79	36.66
8	33.55	34.42
9	33.86	35.72
10	34.71	36.63
11	34.06	33.37
12	34.24	36.01	36.87
13	33.85	34.47	37.61
14	32.80	35.45	37.83
15	34.17	34.02
16	33.73	34.94	37.64
17	33.93	36.54	39.65
18	35.94	34.37
19	33.15	35.12
20	34.30	34.28
AVG:	33.81	35.23	37.71
SD:	1.29	0.99	1.06

Table 3. Line data for confirmatory LoD results

Note: The 69-70del mutation interferes with the detection of the S gene target by the TaqPath COVID-19 assay, which may have rendered the S gene target as not detected ("S gene target failure"). But due to the multi-target test design, the overall test performance of the TaqPath assay is not impacted.

In summary, the LoD testing at 250 GEC/ml (20 GEC/reaction) resulted in 20/20 replicates for automated extraction and amplification of SARS-CoV-2 RNA for identification by RT-PCR. This is the lowest concentration tested that resulted in > 95% accuracy of detection of contrived samples.

Sample Stability

Stability studies evaluated the stability of SARS-CoV-2 in the Spectrum inactivating media for up to 28 days. SARS-CoV-2 samples at 3xLoD (62.5 GEC/reaction; 1562.5 GEC/ml) were used to prepare contrived samples with saliva as the matrix from a single negative donor. Studies involved using two different device lots to collect two samples (for a total of 4 test samples) that were then stored at ambient temperature (20-25°C) for increasing lengths of time. Aliquots of each contrived sample was tested for SARS-CoV-2 using the TaqPath COVID-19 assay at T=0 and on Days 1, 2, 3, 4, 5, 6, 7, 14, 21, and 28. Aliquots of samples were removed and stored at -20°C at various times and then all aliquots (total of 44 samples) were tested as a single testing batch.

{8}------------------------------------------------

Acceptance criteria for stability study:

1. The TaqPath COVID-19 assay detects 3 targets (Orf1ab, N gene, and S gene). A sample is considered positive if at least 2 of the 3 targets are amplified with Ct values <37.
1. Stability is based upon a variance of no more than +/- 3 Ct for each target at given time point from T=0.

Results of stability testing are shown below in Tables 4 and 5.

Time	Orf1abCt average	Orf1abCt SD	Orf1abPositiveCount	N geneCt average	N geneCt SD	N genePositiveCount	S geneCt average	S geneCt SD	S genePositiveCount
T0	33.1	0.98	4/4	31.7	0.32	4/4	32.8	0.34	4/4
D1	31.9	0.85	4/4	31.3	0.45	4/4	33.0	0.49	4/4
D2	32.4	0.33	4/4	31.4	0.33	4/4	33.8	0.61	4/4
D3	32.4	0.40	4/4	31.4	0.35	4/4	33.6	0.26	4/4
D4	32.7	1.23	4/4	31.6	0.46	4/4	34.0	1.74	4/4
D5	32.7	0.47	4/4	31.5	0.28	4/4	34.2	0.86	4/4
D6	32.7	0.43	4/4	31.6	0.29	4/4	33.4	0.47	3/4
D7	33.2	0.87	4/4	31.8	0.32	4/4	34.5	1.15	4/4
D14	33.7	0.84	4/4	32.1	0.19	4/4	33.8	NA	1/4
D21	34.4	0.79	4/4	33.1	0.68	4/4	NA	NA	0/4
D28	33.4	3.25	4/4	34.4	0.53	4/4	NA	NA	0/4

Table 4. Ct average, standard deviation, and positive counts for all targets at all time points.

Table 5. Ct change for each target from T=0 (Day X minus T=0)

Time	Orf1ab Ct changefrom T0	N gene Ct changefrom T0	S gene Ct changefrom T0
T0	NA	NA	NA
D1	-1.25	-0.38	0.29
D2	-0.73	-0.34	1.04
D3	-0.72	-0.29	0.85
D4	-0.47	-0.15	1.19
D5	-0.43	-0.26	1.45
D6	-0.47	-0.10	0.69
D7	0.05	0.05	1.75
D14	0.52	0.38	1.04
D21	1.28	1.40	ND
D28	0.24	2.71	ND

43/44 of the samples tested positive for SARS-CoV-2 at all time points during initial testing. One Day 21 sampled failed to produce a conclusive result when first tested, but upon retesting the sample (per the TaqPath COVID-19 protocol) the sample gave a positive result. All samples gave expected internal control results (amplification of MS2 phage nucleic acid) to monitor the integrity of nucleic acid extractions and RT-PCR for each sample. There were minimal Ct changes over the 28 days of the experiment with the highest variance shown for N gene amplification, but at 2.71 it was within 3 Ct compared to T=0. The S gene target did show a decreased amount of amplification, but this is in agreement with 'S gene target failure (see table 3 above) and is negligible given the 2/3 gene amplification requirement for positive results.

{9}------------------------------------------------

Based upon the pre-defined acceptance criteria, these test results indicate samples are stable in the Spectrum inactivating media for up to 28 days.

Inactivation

An inactivation study was conducted to verify that the Spectrum SDNA-1000 collection device inactivates SARS-CoV-2 (eliminates its virucidal properties) as efficiently as the predicate device.

a) Viral inactivation testing of SARS-CoV-2 was conducted using a Virucidal Suspension Test (In-Vitro Time-Kill method). Starting with a concentration of a SARS-CoV-2 isolate (B.1.1.529 Omicron variant) of 3.2 X 106 TCIDso (approximately 2.24 X 106 PFU), viral preparations were combined with various combinations of Spectrum inactivating media and/or neutralization fluid (for the inactivating media):
Virus Control = virus only (to show virus produces cytopathic effect on tissue culture cells)
Test = Spectrum's inactivating media + virus (for 10 sec or for 60 min) + neutralizer (to show stabilizing solution inactivates virus)
Neutralization Control = Spectrum's inactivating media + neutralizer + virus (to show neutralizing solution eliminates virucidal activity of inactivating media)
Neutralization Toxicity Control = virus + neutralizer (to show neutralizer has no virucidal activity)
Cytotoxicity Control = Spectrum's inactivating media + neutralizer (to show solutions produce not cytotoxic effects)
Cell Control = maintenance media only (to show health of tissue culture cells)

Following treatment of virus, 10-fold dilutions were made of each preparation and incubated with Vero E6 kidney cells that were grow to 80-90% confluency. After a one-hour incubation with the treatments listed above, cells were returned to culture conditions and incubated before cytopathic effects were determined visually with an inverted compound microscope.

Acceptance criteria for Virucidal Suspension Test: Results met the following acceptance criteria.

1. At least a 4 log10 of TCID50 would be recovered from the virus control
1. At least a 3 log10 reduction in titer could be demonstrated beyond the cytotoxic level
1. Spectrum inactivating media was fully neutralized after the timed exposure such that the difference in virus titer for the Neutralization Control, Neutralization Toxicity Control, and Virus Control did not exceed 1.0 log10

Three different lots of devices were tested for viricidal activity, with each test performed in two replicates per device. Plating of each replicate was performed four times. Results of testing for one device lot are summarized in Table 6.

{10}------------------------------------------------

	10sec.	60min.	Dilution(- Log10)	VirusControl	NeutralizationControl	NeutralizerToxicity Control	CytotoxicityControl
Rep 1	0000	0000	-3	++++	NT	NT	0000
Rep 2	0000	0000	-4	++++	++++	++++	0000
Rep 3	0000	0000	-5	++++	++++	++++	0000
Rep 4	0000	0000	-6	0+++	0+00	00+0	NT
Rep 5	0000	0000	-7	+000	0000	0+00	NT
Rep 6	0000	0000	-8	0000	0000	0000	NT
TCID50 (Log10)	≤ 2.50			6.50	5.75	6.00	≤ 2.50
Log10 Reduction	≥ 4.00
Average Log10Reduction	≥ 4.00
PercentReduction	≥ 99.99%
Average PercentReduction	≥ 99.99%

Table 6. Viral Inactivation Summary

At the 1:10,000 dilution the virus is completely cytopathic with the host cells (Virus control) but completely inactivated at 10-second or 60-minute exposures to the inactivating media (Test). The virucidal action of the inactivating media was stopped by the neutralization solution (Neutralization control). The neutralization solution was shown to have no cytopathic effect on the cell mono layer or the virus (Neutralizer Toxicity Control). The inactivating media and the neutralizer combined did not produce any cytotoxic effects (Cytotoxicity control) on the cell mono layer.

Under the experimental conditions described above the Spectrum inactivating media inactivates SARS-CoV-2 by an average of >4.00 log10 (>99.99%) following a 10-second exposure and by an average of >4.00 log10 (>99.99%) following a 60-minute exposure. The Spectrum SDNA-1000 collection device with inactivating media showed no cytotoxicity of Vero6 cells when used at a 1:1000 dilution.

Conclusion:

The Spectrum Solutions Saliva Collection devices have the same intended purpose, indications and technological characteristics as the predicate.

The Spectrum Solutions Saliva Collection device does not raise different questions regarding safety and effectiveness as compared to predicate device. The proposed device is as safe, as effective, and performs as well as or better than the predicate device. The information submitted in this premarket notification supports a substantial equivalence decision.

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.