(88 days)
Not Found
No
The summary describes a physical device for collecting and stabilizing saliva samples and does not mention any computational or analytical functions that would typically involve AI/ML.
No
The device is for the collection and stabilization of samples for in vitro diagnostic testing, not for treating or diagnosing any condition.
No
The device is for the collection and stabilization of viral nucleic acids for in vitro diagnostic testing, but it is not the diagnostic test itself. It prepares the sample for a legally marketed molecular diagnostic device, which performs the actual diagnosis.
No
The device description explicitly states it consists of physical components: a plastic tube, funnel, cap, and fluid chamber containing media. It is a hardware device for collecting and stabilizing saliva samples.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is designed for "in vitro diagnostic testing of saliva samples." It also mentions that the saliva sample is "suitable for use with legally marketed molecular diagnostic device."
- Purpose: The device's primary function is to collect and stabilize a biological sample (saliva) for subsequent laboratory testing to diagnose a condition (suspected SARS-CoV-2). This aligns directly with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Context: The device is intended to be used by a "health care provider" for samples "suspected of containing SARS-CoV-2," further emphasizing its role in a diagnostic process.
The information provided in the "Device Description," "Summary of Performance Studies," and the mention of a "Predicate Device(s)" (which is also an IVD) all support the conclusion that this is an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QBD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Saliva samples, human specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care 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)
Detection Limit
- Study Type: Limit of Detection (LoD) testing.
- Sample Size:
- Preliminary LoD: 5 samples for each of 7 concentrations (0, 10, 20, 50, 100, 250, 500 GEC/reaction).
- Confirmatory LoD: 20 samples for 15 GEC/reaction and 20 GEC/reaction concentrations.
- Key Results:
- Preliminary LoD based on 2/3 gene target amplification: 20 GEC/reaction.
- Confirmatory testing supported an LoD of 20 GEC/reaction with 20/20 replicates showing amplification for ORF1ab and N gene.
- The lowest concentration tested that resulted in > 95% accuracy of detection of contrived samples was 250 GEC/ml (20 GEC/reaction).
Sample Stability
- Study Type: Stability study.
- Sample Size: SARS-CoV-2 samples at 3xLoD (62.5 GEC/reaction; 1562.5 GEC/ml) were used to prepare contrived samples with saliva from a single negative donor, using two different device lots to collect two samples (total of 4 test samples). Aliquots of each contrived sample were tested at T=0 and on Days 1, 2, 3, 4, 5, 6, 7, 14, 21, and 28. Total of 44 aliquots tested as a single batch.
- Key Results:
- 43/44 of the samples tested positive for SARS-CoV-2 at all time points.
- Minimal Ct changes over 28 days, with the highest variance for N gene amplification (2.71) remaining within +/- 3 Ct compared to T=0.
- S gene target showed decreased amplification, but this was attributed to S gene target failure and considered negligible due to the 2/3 gene amplification requirement for positive results.
- Samples are stable in the Spectrum inactivating media for up to 28 days.
Inactivation
- Study Type: Viral inactivation testing using a Virucidal Suspension Test (In-Vitro Time-Kill method).
- Sample Size: Three different lots of devices were tested, with each test performed in two replicates per device. Plating of each replicate was performed four times.
- Key Results:
- Spectrum inactivating media inactivates SARS-CoV-2 (B.1.1.529 Omicron variant) by an average of >4.00 log10 (>99.99%) following a 10-second exposure.
- Inactivation 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 at a 1:1000 dilution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Limit of Detection (LoD): 20 GEC/reaction (250 GEC/ml) demonstrated >95% accuracy in detecting contrived samples.
- Inactivation: >4.00 log10 (>99.99%) viral reduction of SARS-CoV-2 following 10-second and 60-minute exposures.
- Stability: SARS-CoV-2 RNA stability maintained for 28 days at 20-25 °C, with Ct variance within +/- 3 Ct from T=0.
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.
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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 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
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Indications for Use
510(k) Number (if known)
Device Name Saliva Collection
Indications for Use (Describe)
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.
| 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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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:
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.
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.
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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 Saliva | |
| Collection Device | DNA/RNA Shield Collection Tube | |
| General Device Characteristic | ||
| Similarities | ||
| Intended Use/Indications For | ||
| 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. | 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. | ||
| Additive/Reagent | Nucleic Acid Stabilization | |
| solution | 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, and | ||
| stabilizes nucleic acids | Same | |
| Material | Medical-grade polypropylene | Same |
| Sterility | Non-Sterile | Same |
| General Device Characteristic | ||
| Differences | ||
| Specimen Type | Saliva only | Upper, lower respiratory, and |
| saliva | ||
| Device Material | Tube - Polypropylene Funnel | |
| Polypropylene | ||
| Cap - Polypropylene & HDPE | Plastic Collection Tube pre-filled | |
| with DNA/RNA Shield transport | ||
| media |
5
| | Spectrum's Nucleic Acid
Stabilization Solution | |
|-------------------|-----------------------------------------------------|-----------------------------------------------------|
| Inactivation test | Greater than 4 Log viral
reduction in 10 seconds | Greater than 2 log viral
reduction 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 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:
-
- 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 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.