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Oragene®•Dx is intended for use in the non-invasive collection of saliva samples for in vitro diagnostic testing of human DNA. 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 may be collected by a healthcare professional or non-healthcare professional, such as a lay user. Saliva samples collected using Oragene®•Dx are stabilized and isolated for use in downstream diagnostic testing applications. Saliva samples collected using Oragene®•Dx can be transported and/or stored long term at ambient conditions

Oragene®●Dx family of collection devices offers reliable collection, transportation and long-term ambient temperature storage of human DNA from saliva. Oragene®●Dx devices are a noninvasive alternative for collecting high quality and quantity DNA for use with prescription and over-thecounter (direct-to-consumer) diagnostic testing applications.

Oragene®●Dx devices consist of a collection tube with a funnel lid attached (containing a stabilizing liquid). Saliva is delivered directly by spitting into the collection tube or may be transferred into the Oragene®●Dx container using a sponge. 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.

Oragene®●Dx saliva collection devices are suitable for use with prescription and over-the-counter (direct-to-consumer) downstream diagnostic testing applications, systems or platforms. Test or assay manufacturers must validate the use of Oragene®●Dx for their specific indications for use.

Using DNA obtained from an Oragene®●Dx sample, laboratory testing is performed on genotyping systems or platforms in a CLIA (Clinical Laboratory Improvement Amendments) certified laboratory. The resulting genetic information may be used to generate a personalized health report related to detected mutations and may be used by medical and health practitioners as an aid in patient management.

The document describes the Oragene®•Dx saliva collection device and its performance characteristics to support its intended use for in vitro diagnostic testing of human DNA.

Here's the breakdown of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Oragene®•Dx device are largely demonstrated by referencing prior 510(k) clearances (K110701, K141410, K152556) and its compatibility with already FDA-cleared test systems. The performance characteristics focus on the stability and suitability of the collected DNA for downstream diagnostic applications.

• 30 months at room temperature
• 12 months at -20±5°C and 6±4°C (for device models OGD-500, OGD-510, OGD-575, OGD-600, OGD-610, OGD-675, which have the same physical and chemical components as previously cleared devices). |
  | Post-collection Sample Stability | Supported by studies in K110701 and K152556 (specifically for OGD-500, and inferred for the proposed device due to identical physical/chemical components), claiming:
• 12 months at room temperature, -20±5°C or 6±4°C
• 3 months at 50±5°C
  Studies evaluated DNA yield, DNA concentration, A260/A280 ratio, and microbial content. |
  | Sample Volume Tolerance | Demonstrated by previous studies (K110701) where underfilling (by 25% or 50% of target) or overfilling (by 50% of target) did not impact downstream performance, despite affecting DNA yield. Collected samples ranged from 0.58 mL to 3.64 mL of saliva. Further confirmed with FDA cleared test systems: eSensor® Warfarin Sensitivity Saliva Test (K110786), 23andMe PGS (DEN140044, DEN160026), and Akonni TruDiagnosis® System (K183530). |
  | Interfering Substances (Endogenous) | Successfully demonstrated with FDA cleared test systems: eSensor® Warfarin Sensitivity Saliva Test (K110786), 23andMe PGS (DEN140044, DEN160026), and Akonni TruDiagnosis® System (K183530). No observable effect on performance. |
  | Interfering Substances (Exogenous) | Successfully demonstrated with FDA cleared test systems: eSensor® Warfarin Sensitivity Saliva Test (K110786), 23andMe PGS (DEN140044, DEN160026), and Akonni TruDiagnosis® System (K183530). No observable effect on performance. |
  | Over-the-Counter (Direct-to-Consumer) Use | Previously evaluated with 23andMe PGS (K141410, DEN140044) using OGD-500.001. A user comprehension study using standard Oragene®•Dx devices (K192920) in a simulated over-the-counter setting was completed. This usability study evaluated user comprehension and compliance with Instructions for Use (IFU), specifically:
• Correct sample collection (physical parameters: volume, compliance, DNA concentration, call rate).
• User comprehension of IFU (through demographics, ease of use, collection, and shipping instructions survey).
  The study results met acceptance criteria, demonstrating successful use in a direct-to-consumer setting. |

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

• Test Set Sample Size: The document does not explicitly state a specific numerical sample size for the user comprehension study conducted for the K192920 submission. It mentions "Potential users enrolled in usability studies." For other performance aspects (Reproducibility, Stability, Volume Tolerance, Interfering Substances), the document largely references previous 510(k) clearances and compatibility with existing FDA-cleared test systems, implying the sample sizes from those original studies were deemed sufficient.
• Data Provenance: The document does not specify the country of origin for the data for any of the studies mentioned. The submitter is DNA Genotek Inc., located in Ottawa, Ontario, Canada.
• Retrospective/Prospective: The user comprehension study for over-the-counter use appears to be prospective, as it involved "Potential users enrolled in usability studies collected saliva samples at home." The referenced studies for stability and other analytical performance characteristics were likely prospective as well, as they involved specific testing protocols to establish performance claims.

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

• The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of clinical adjudication.
• For the user comprehension study, the "ground truth" was established by objective measures such as successful collection of saliva, compliance with instructions, DNA concentration, and PCR call rate, as well as subjective user comprehension surveys. This process does not typically involve expert consensus on the "truth" of a clinical condition.
• The overall "truth" for the device's function as a DNA collection device is its ability to yield high-quality DNA suitable for downstream diagnostic testing, as demonstrated by compatibility with FDA-cleared molecular diagnostic platforms.

4. Adjudication Method for the Test Set

• Not applicable in the context of this device's performance claims. The studies focus on analytical performance (DNA yield, stability, compatibility) and user comprehension/compliance, rather than diagnostic accuracy requiring adjudication of clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• Not applicable. This device is a saliva collection kit, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant to its evaluation.

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

• Not applicable. This device is a physical collection kit, not an algorithm. Its performance is inherent to the physical and chemical properties of the kit and the stabilization solution, as well as user compliance with instructions.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The "ground truth" for the performance of the Oragene®•Dx device is primarily based on analytical performance metrics (DNA yield, DNA concentration, purity ratios (A260/A280), microbial content, PCR call rates) and functional compatibility with established FDA-cleared molecular diagnostic test systems.
• For the Over-the-Counter use, the "ground truth" includes user compliance with instructions and successful sample collection based on objective parameters (volume, DNA quality) and user comprehension through surveys.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical collection kit, not a machine learning model that requires a training set. The performance is based on established chemical and physical principles and validated through testing.

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

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

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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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