(171 days)
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.
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.
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.
§ 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.