(88 days)
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.
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.
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 |
§ 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.