(203 days)
The PPH Saliva Collection Kit is designed for use in the non-invasivation, 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 device is intended to be used by a health care provider for the collection of saliva samples suspected of containing SARS-CoV-2. The saliva sample is stabilized and suitable for use with legally marketed molecular diagnostic devices.
The PPH Saliva Collection Device contains a plastic bulb pipette, paper cup, plastic tube with PPH Saliva collection buffer (0.3 ml). This collection device designed for the collection of human saliva samples. It is designed for use in the non-invasive collection, inactivation 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 provided text describes the performance evaluation of the PPH Saliva Collection Kit, a device 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 a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf-life Stability | Not explicitly stated (implied maintenance of physical characteristics, pH, color, volume loss, and functional performance over time) | 9 months at room temperature (15-30°C) with no observed volume loss, significant pH change, or color change. |
| Physical stability (appearance) | Clear liquid without precipitation, no observed volume loss. | |
| Color stability | No color change. | |
| pH stability | No significant change in buffer pH. | |
| Limit of Detection (LoD) | Detection of SARS-CoV-2 with >95% accuracy | N1 Target: 0.25 copies/µL with 100% (20/20) detection. |
| N2 Target: 0.25 copies/µL with 95% (19/20) detection. | ||
| Sample Stability | Samples stable for up to 7 days at ambient temperature (20-25°C) | Largest Ct difference observed was 0.40 at 8 days. Test results fall within established acceptance criteria, indicating stability for up to 7 days. |
| Inactivation | No detectable virus (zero positive plaques) after 4 days growth following exposure to PPH Saliva Collection Kit buffer | SARS-CoV-2 inactivation after 90 seconds of exposure to PPH Saliva Collection Kit buffer, with no PFUs obtained after 60 seconds and onward. |
| Cytotoxicity | Buffer not toxic to a cell monolayer at a certain dilution ratio | Concentration of 1:5,000 PPH Saliva Collection Kit buffer determined not to have a cytopathic effect on Vero E6 cells. |
2. Sample Size Used for the Test Set and Data Provenance
- Limit of Detection (LoD) Study:
- Preliminary LoD: 3 replicates for each serial dilution.
- Confirmatory LoD: 20 replicates for each of the four concentrations tested.
- Sample Stability Study:
- Low positive samples: 20 samples per device lot for 3 lots, totaling 60 low positive samples.
- Negative samples: 10 samples per device lot for 3 lots, totaling 30 negative samples.
- Inactivation Assay: 6 replicates for each time point.
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. It describes laboratory studies conducted to evaluate the device's performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The ground truth for LoD, sample stability, and inactivation studies appears to be based on laboratory measurements (e.g., SARS-CoV-2 spiked into saliva, PCR results, plaque assays).
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1) as there is no mention of human readers or experts establishing ground truth through consensus. The ground truth is established through laboratory analyses.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The PPH Saliva Collection Kit is a collection and stabilization device, not an AI-assisted diagnostic tool for human interpretation.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The PPH Saliva Collection Kit is a physical device for sample collection and stabilization, not a software algorithm or an AI-based system. Its performance is evaluated through its ability to stabilize and inactivate viral nucleic acids, which are then processed by legally marketed molecular diagnostic devices.
7. The Type of Ground Truth Used
The ground truth for the performance studies was:
- Limit of Detection: Known concentrations of SARS-CoV-2 (inactivated and spiked) in saliva, detected via rRT-PCR.
- Sample Stability: Known concentrations of inactivated SARS-CoV-2 spiked into saliva, with stability assessed by rRT-PCR over time.
- Inactivation: Known concentrations of live SARS-CoV-2, with inactivation assessed by plaque assay (detection of live virus).
8. The Sample Size for the Training Set
The document does not mention a "training set" as it pertains to AI/machine learning. The studies described are performance validation studies for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/machine learning model, this question is not applicable.
§ 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.