(261 days)
Oragene Dx devices are intended for use in the non-invasive collection of saliva samples. Human DNA from the saliva sample is isolated, stabilized, and suitable for use in FDA cleared molecular diagnostic applications. Saliva may be collected by spitting directly into the Oragene Dx container or may be transferred into the Oragene Dx container using a sponge. Saliva samples collected using Oragene Dx are stabilized and can be transported and/or stored long term at ambient conditions.
The Oragene-Dx family of products offers reliable collection, transportation and long-term room temperature storage of human DNA from saliva. Oragene Dx is a non-invasive alternative for collecting high quality and quantity DNA for use in molecular diagnostic applications. Oragene-Dx is a device family available in multiple device formats or models.
Oragene-Dx device formats OGD-510, OGD-600, OGD-610 and OGD-675, have the same collection principle and intended use as the FDA cleared Oragene-Dx formats (K110701). All Oragene-Dx formats consist of a collection tube, a DNA stabilizing liquid and optional sponges for assisted collection. In addition, Oragene·Dx device formats are made from the same physical and chemical materials. Oragene Dx formats differ in the amount of DNA stabilizing liquid in the tube and in the difference in the amount of saliva to be collected. The ratio of final sample to stabilizing liquid volume remains the same.
Saliva collection can take place at home, in a laboratory setting, physician's office, or in the field by untrained (naïve) or professional users. Saliva samples are collected into the device directly by spitting or by using the provided sponges. After saliva is collected, the stabilizing liquid is mixed with the sample. Upon contacting saliva cells, the stabilizing liquid lyses cellular and nuclear membranes to release and stabilize nucleic acids (DNA). Oragene-Dx Samples can be immediately processed, transported or stored for future use. Samples can be shipped at ambient temperature to the laboratory for processing.
Oragene-Dx device pre-collection shelf life is 24 months at room temperature from the date of manufacture. Post collection, Oragene Dx samples are stable at room temperature for up to 12 months. Oragene Dx device performance and sample integrity are maintained during typical ambient transport and storage conditions.
This document (K152556) describes a 510(k) premarket notification for the Oragene®Dx OGD-510, Oragene®Dx OGD-600, Oragene®Dx OGD-610, and Oragene®Dx OGD-675 devices. These devices are intended for the non-invasive collection of saliva samples, from which human DNA can be isolated, stabilized, and used in FDA-cleared molecular diagnostic applications. The submission references studies performed for the predicate device (Oragene®Dx OGD-500, K110701) to support the substantial equivalence of the new devices.
1. Table of acceptance criteria and reported device performance:
Since the document bases its claims on substantial equivalence to a predicate device (K110701) and applicable studies mentioned in that predicate, specific numerical acceptance criteria for the new devices are not explicitly stated in a tabular format within this document. Instead, the document states that the performance of the new devices is "the same as predicate" or that "both OGD-510 and OGD-500 samples met acceptance criteria for DNA concentration, total DNA yield, A260/A280 ratio and performance on the eSensor Warfarin Sensitivity Saliva Test."
The key performance characteristics and their reported outcomes, primarily referencing the predicate K110701, are summarized below:
| Performance Characteristic | Acceptance Criteria (Implied / Referenced from K110701) | Reported Device Performance (New Devices OGD-510, OGD-600, OGD-610, OGD-675) |
|---|---|---|
| Reproducibility/Precision | Meeting study acceptance criteria (as per K110701) | Demonstrated (referencing Section 18.4 of K110701). Overall, all samples tested met study acceptance criteria. |
| Pre-collection Shelf-Life | 24 months at room temperature | Supported by studies in K110701 (same physical/chemical components). |
| 12 months at -20±5°C and 6±4°C | Supported by studies in K110701 (same physical/chemical components). | |
| Post-collection Sample Stability | 12 months at room temperature, -20±5°C or 6±4°C | Supported by studies in K110701 (same physical/chemical components). |
| 3 months at 50±5°C | Supported by studies in K110701 (same physical/chemical components). | |
| Sample Volume Tolerance | No impact on performance from underfilling by 25-50% or overfilling by 50% of target volume (as per K110701) | Demonstrated (referencing Section 18.2 of K110701). Downstream performance was not affected by over or under spitting. |
| Interfering Substances | No impact on performance from endogenous/exogenous substances, 100% agreement between eSensor® Warfarin Sensitivity Test genotyping and bidirectional sequencing (as per K110701) | Demonstrated (referencing Section 18.6 of K110701), with the caveat of donor collection instructions (no eating, drinking, smoking, or chewing gum 30 min prior to collection). |
| Analytical Performance (DNA Concentration, Yield, A260/A280, Genotyping Agreement with eSensor Warfarin Sensitivity Saliva Test) | Meeting acceptance criteria for DNA concentration, total DNA yield, A260/A280 ratio, and performance on the eSensor Warfarin Sensitivity Saliva Test. | For OGD-510 (and applicable to OGD-610): Both OGD-510 and OGD-500 samples met acceptance criteria for these parameters. No significant difference in any performance parameters (except total sample DNA yield). |
2. Sample size used for the test set and the data provenance:
The document refers to studies in the predicate K110701 for most performance characteristics. For the new comparison study performed for OGD-510 vs. OGD-500, the sample size is not explicitly mentioned. The data provenance is implied to be from Canada, as the submitter, DNA Genotek Inc., is located in Ottawa, Ontario, Canada. The studies are retrospective references to the predicate device or a new comparison study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not explicitly provided in the document. The ground truth for comparative performance (genotyping) would likely be established by the "bidirectional sequencing" method, but details on the experts involved in interpreting this or verifying the ground truth for other studies (e.g., stability) are not given.
4. Adjudication method for the test set:
Not applicable or provided for this type of device and performance testing. The "ground truth" for genotyping involved comparison to bidirectional sequencing.
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:
Not applicable. This device is a sample collection and stabilization device, not an AI-assisted diagnostic tool requiring human reader interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device for sample collection, not an algorithm. The "performance" refers to the ability to collect and preserve DNA for downstream molecular diagnostic applications. The comparison studies against the eSensor® Warfarin Sensitivity Saliva Test (K110786) are standalone evaluations of the collected sample's compatibility with a molecular diagnostic test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the analytical performance (genotyping agreement), the ground truth was established by bidirectional sequencing. For other performance characteristics like stability and reproducibility, the ground truth would be based on established laboratory methods and controls to demonstrate the integrity and functionality of the DNA.
8. The sample size for the training set:
Not applicable. This device is a physical sample collection device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set is involved for this type of device.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.