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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:

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.

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Oragene®●Dx OGD-500.001 is intended for use in the non-invasive collection of saliva samples. DNA from the saliva sample is isolated, stabilized, and suitable for over-the-counter use with FDA cleared, approved, or legally marketed exempt DNA carrier screening genotyping tests. Saliva samples collected using Oragene®Dx OGD-500.001 are stabilized and can be transported and/or stored long term at ambient conditions.

Oragene Dx family of collection devices offers reliable collection, transportation and longterm ambient temperature storage of human DNA from saliva. Oragene Dx OGD-500.001 is a noninvasive alternative for collecting high quality and quantity DNA and is suitable for use in over-thecounter molecular genotyping applications. Oragene-Dx OGD-500.001 consists of a collection tube with a funnel lid attached (containing a stabilizing liquid). Saliva is delivered directly by spitting into the collection tube. Saliva collection can take place at home, in a laboratory setting, physician's office, or in the field. Untrained (naïve) or professional users can carry out saliva collection. After saliva is collected, the stabilizing liquid is mixed with the sample. A small cap is provided to close the tube for transport and storage (funnel with lid is removed and discarded). Upon contacting saliva cells, the stabilizing liquid lyses cellular and nuclear membranes to release and stabilize nucleic acids (DNA). 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 samples are stable at room temperature for up to 12 months. Device and sample integrity are preserved during typical ambient transport and storage conditions.

The document describes the Oragene® Dx OGD-500.001 device, a saliva collection kit, and its performance characteristics for substantial equivalence to a predicate device (Oragene® Dx OGD-500).

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

The acceptance criteria are not explicitly listed in a single table with numerical targets, but rather are inferred from the performance characteristics studies conducted and the claims made. The summary demonstrates that the device performs equivalently or acceptably based on these studies.

2. Sample Size Used for the Test Set and Data Provenance

• Reproducibility/Precision: Specific sample size not provided in this document, but referred to co-submission DEN140044 for the 23andMe PGS Carrier Screening Test.
• Interfering Substances (Endogenous): 10 individuals for saliva samples.
• Interfering Substances (Exogenous): 5 individuals at 3 time points (baseline, 0 min, 30 min) for each substance; smoking tested in a separate study (sample size not specified for smoking or overall study).
• Consumer User Study: 302 individuals completed the survey and provided a saliva sample. The majority (96.3%) were naïve users.

Data Provenance (Retrospective or Prospective / Country of Origin):

• The studies regarding pre-collection shelf-life and post-collection sample stability and sample volume tolerance refer back to information established in the predicate device's 510(k) (K110701). This suggests a mix of potentially existing data from the predicate and current validation for the proposed device where applicable.
• The reproducibility, interfering substances, and consumer user study were performed in conjunction with the 23andMe PGS Carrier Screening Test (co-submission DEN140044). The study design (e.g., collecting samples before/after substances) indicates these were prospective studies. The country of origin for the data is not explicitly stated, but 23andMe is a US-based company, which might imply data from the US market. The submitter is DNA Genotek Inc., located in Canada.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (a sample collection kit) does not typically involve expert review for "ground truth" in the same way an imaging or diagnostic algorithm would. The ground truth in these studies is the actual measured performance of the device in yielding DNA, maintaining DNA quality, and ensuring accurate genotyping by a downstream FDA-cleared test. The "experts" would be the laboratory personnel and analytical methods used for DNA extraction, quantification, and genotyping, verifying aspects like DNA yield, purity, and concordance with known genetic markers. No specific number or qualifications of "experts" are provided as a distinct category for establishing ground truth, as the ground truth is based on laboratory measurements and analytical results.

4. Adjudication Method for the Test Set

Not applicable for a sample collection device. Adjudication methods like "2+1" (two readers agree, third resolves) are typically used in clinical imaging or diagnostic studies where subjective interpretation is involved. Here, the outcomes are objective laboratory measurements (DNA concentration, genotype concordance).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is not relevant for this device. This type of study compares the performance of multiple human readers on multiple cases, often with and without AI assistance, to measure the effect of AI on human reader performance. The Oragene Dx OGD-500.001 is a sample collection device, not an AI diagnostic tool that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, the performance of the device itself (collecting and stabilizing DNA) is assessed in a standalone manner. The studies evaluate the device's ability to provide suitable DNA for downstream testing, independently of human interpretation of that DNA. The "algorithm" here is the collection and stabilization process, and its output (stabilized DNA) is directly measured and assessed against objective criteria (DNA yield, purity, genotyping concordance).

7. The Type of Ground Truth Used

The ground truth used in these studies is primarily objective laboratory measurements and genotyping concordance.

• DNA Yield and Purity: Measured directly using laboratory techniques (e.g., spectrophotometry for A260/A280 ratio, fluorometry for DNA concentration).
• Genotyping Concordance: Comparison of genotypes obtained from samples collected with the device against reference genotypes (e.g., from unadulterated samples for interference studies, or known genetic profiles if applicable), using an FDA-cleared genotyping test (23andMe PGS Carrier Screening Test). This is a form of outcome data as it assesses the device's ability to enable correct biological outcomes (accurate genotyping).
• Microbial Content: Laboratory assay for the presence of microbes.

8. The Sample Size for the Training Set

No training set is mentioned or applicable for this type of device. Training sets are typically used for machine learning or AI models, which is not the function of this saliva collection device. The device itself is a physical product, and its performance is characterized through validation studies, not by training an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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Oragene-Dx is intended for use in the non-invasive collection of saliva samples. 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. All formats consist of a collection tube, stabilizing liquid and optional sponges for assisted collection. After saliva is collected, the stabilizing liquid is mixed with the sample. Saliva can be delivered directly by spitting or using provided sponges to transfer saliva into the device.

Here's a breakdown of the acceptance criteria and study information for the Oragene·Dx device, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Oragene·Dx device are not explicitly stated as distinct pass/fail thresholds in the provided document. However, the performance characteristics and the successful outcome of the studies (e.g., 100% correct calls after re-testing in most cases) imply that these reported values met the internal and FDA requirements for substantial equivalence. The key performance metrics evaluated were:

• DNA Yield (µg): Quantity of DNA extracted.
• DNA Concentration (ng/µL): Concentration of DNA in the extracted sample.
• A260/A280 Ratio: Indicator of DNA purity (ratio of absorbance at 260 nm to 280 nm). A value around 1.7 to 2.0 typically indicates pure DNA.
• % Correct Calls on downstream molecular diagnostic application: The ability of the extracted DNA to produce accurate results in the eSensor® Warfarin Sensitivity Saliva Test.
• Stability: Ability to maintain DNA quality and quantity over time and under various storage/transport conditions.
• Tolerance to interfering substances: Ability to perform correctly despite the presence of common interfering substances.

2. Sample Size Used for the Test Set and Data Provenance

• Performance Characteristics (Initial):
  • OGD-500: 450 samples from 245 unique donors.
  • OXD-525 & OYD-500: Subset of 45 donors.
  • OGD-575: Subset of 43 donors.
• Sample Volume Tolerance Study: 240 samples using OGD-500.
• Reproducibility Study: 3 samples from each of 10 donors (total 30 samples collected, tested in triplicate by 4 operators, leading to 354-360 data points for yield/concentration, and 87-90 samples per SNP per operator for eSensor test).
• Post-Collection Sample Stability: 30 donors, each collecting four saliva samples for each of the 3 specified Oragene Dx formats (total 360 samples initially). A sub-population of 564 DNA samples across all time-points were tested on the eSensor® Warfarin Sensitivity Saliva Test.
• Interfering Substances Study: Samples from donors with known genotypes (exact number not specified beyond "samples").

Data Provenance: The document does not explicitly state the country of origin for the donors or samples. The study appears to be prospective in nature, as samples were "collected" for the purpose of the studies described (e.g., "samples were collected using OGD-500," "30 donors each self-collect four saliva samples").

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• The document does not specify the number of experts or their qualifications for establishing the ground truth of the genetic information (e.g., Warfarin Sensitivity SNPs) used with the eSensor® Warfarin Sensitivity Saliva Test. The "known genotypes" mentioned in the interfering substances study imply that the ground truth for the genetic markers was pre-established for the donors. The "Correct Calls" refer to the agreement with these known genotypes.

4. Adjudication Method for the Test Set

• The document does not describe an explicit adjudication method for discrepancies in the eSensor® Warfarin Sensitivity Saliva Test results. Instead, it mentions "re-testing" for initial no-calls. For instance, in the reproducibility study, "46 first-run no-calls were due to two runs... invalidated due to DNA Contamination Monitor (DCM) failures," and "The other first-pass no calls were low signal... positive control failure... and contradictory score." These suggest technical reasons for initial non-results, which were then resolved by re-testing. One incorrect call was "due to operator error resolved upon investigation," implying an internal review process rather than an independent expert adjudication of the initial assay result.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not explicitly done in the context of human readers improving with AI vs. without AI assistance. This device is a sample collection kit, not an AI diagnostic tool that assists human readers.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance study was done in the sense that the extracted DNA from the Oragene·Dx device was tested directly on the eSensor® Warfarin Sensitivity Saliva Test, and the results (correct calls, incorrect calls, no-calls) were reported for the device's output. The performance of the Oragene·Dx device in preparing samples suitable for subsequent molecular diagnostic testing is evaluated objectively based on the accuracy of the eSensor test. This is considered "standalone" for the sample collection device's function as its "output" (DNA) is assessed by a subsequent analytical device without human interpretation of its own performance.

7. Type of Ground Truth Used

• The ground truth used for evaluating the performance of the extracted DNA on the eSensor® Warfarin Sensitivity Saliva Test was known genotypes for the relevant SNPs (2C92, 2C93, VKORC1). This implies that the genetic information of the donors was determined by a reliable, presumably validated, method prior to the study.

8. Sample Size for the Training Set

• The document describes performance evaluation studies but does not mention a training set as this is a sample collection device, not a machine learning algorithm that requires training. The studies described are validation studies for the device's performance characteristics.

9. How the Ground Truth for the Training Set Was Established

• As there is no mention of a training set or machine learning algorithm, this question is not applicable. The "ground truth" (known genotypes) for the performance evaluation was established beforehand for the test samples through undisclosed methods.

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