(94 days)
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.
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.
The provided text describes the DNA/RNA Shield Collection Tube's performance data, which supports its substantial equivalence to a predicate device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Inactivation | - Inactivation of SARS-CoV-2 virus efficiently as other legally marketed devices. |
- Equivalent performance to PrimeStore MTM for inactivation. | > 2.0 log reduction in viral titer after 30 min exposure. |
| Limit of Detection (LoD) | - Determine SARS-CoV-2 LoD in combination with a legally marketed rRT-PCR Kit. | 250 GEC/mL (15 GEC/reaction) for sputum and oral swab. |
| Specimen Stability | - SARS-CoV-2 RNA from sputum and oral swab preserved and stabilized. - Acceptance criteria of +/- 3.0 Ct after 4 weeks storage at 20-25°C.
- Equivalent performance to the legally marketed predicate device. | RNA stabilized in DNA/RNA Shield met the acceptance criteria of +/- 3.0 Ct after 4 weeks storage at 20-25°C. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set in each study. However, it indicates:
- Inactivation Study: High concentrations of SARS-CoV-2 virus (9x10^6 PFU) were inoculated.
- Limit of Detection Study: "Samples" were extracted and amplified.
- Specimen Stability Study: "Contrived specimens with sample matrices and SARS-CoV-2 RNA spiked into DNA/RNA Shield" were used.
The data provenance is retrospective in the sense that the studies were conducted to gather performance data on the device. The specific country of origin of the data is not mentioned, but the submitting company is Zymo Research in Irvine, California, USA, suggesting the studies were likely conducted in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies described are laboratory-based performance evaluations (inactivation, LoD, stability) and do not involve human interpretation or expert consensus for establishing ground truth in the typical clinical sense.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are laboratory-based performance evaluations, not involving human interpretation or 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
This information is not applicable. The device is a "DNA/RNA Shield Collection Tube," a sample collection and stabilization device, not an AI-powered diagnostic or imaging tool that would typically involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a sample collection and stabilization tube, not an algorithm, so the concept of "standalone performance" in this context is irrelevant. The performance evaluated is the physical and chemical properties of the shield media itself.
7. The Type of Ground Truth Used
- Inactivation Study: The ground truth for inactivation was established by measuring the viability of the virus (cytopathic effect, CPE) after exposure to the DNA/RNA Shield medium. This is a direct biological measure.
- Limit of Detection Study: The ground truth for LoD was established by spiking known concentrations of SARS-CoV-2 RNA (measured in GEC/mL) into the medium and performing rRT-PCR. This is an analytical measurement based on a known standard.
- Specimen Stability Study: The ground truth for stability was established by spiking SARS-CoV-2 RNA into contrived specimens and then measuring the Ct values from rRT-PCR over time, comparing them to a baseline. This also relies on analytical measurements against a known standard.
In all cases, the ground truth is based on pre-defined analytical standards and direct biological or molecular measurements, not expert consensus, pathology, or outcomes data in a clinical setting.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product (collection tube and media), not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
§ 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.