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510(k) Data Aggregation
(266 days)
ORAGENE DX OGD-500.001
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.
| Acceptance Criteria (Inferred) | Reported Device Performance (Oragene® Dx OGD-500.001) |
|---|---|
| Reproducibility/Precision: Reliable genotyping across multiple operators, days, and reagent lots. | Demonstrated reproducibility when used with the 23andMe PGS Carrier Screening Test (details in co-submission DEN140044). |
| Pre-collection Shelf-life: Stability for extended periods. | 24 months at room temperature; 12 months at -20°C ± 5°C and 6°C ± 4°C. (Supported by K110701, as device components are identical to predicate). |
| Post-collection Sample Stability: DNA yield, concentration, A260/A280 ratio, and microbial content maintained. | 12 months at room temperature, -20°C ± 5°C or 6°C ± 4°C; 3 months at 50°C ± 5°C. (Supported by K110701, as device components are identical to predicate). |
| Sample Volume Tolerance: Functionality maintained with varying saliva volumes. | Underfilling by 25% or 50%, or overfilling by 50% did not impact performance. Mean total sample volume in consumer study: 4.25 ± 0.56 mL (equivalent to 2.25 mL saliva). 97.7% of samples were within acceptable range (2.58 to 5.64 mL total sample). |
| Limit of Detection (DNA Concentration): Sufficient DNA for downstream testing. | 98.3% of samples in the consumer study contained the minimum amount of DNA required for testing. Re-extraction performed if initial concentration is low. |
| Interfering Substances (Endogenous): No impact on genotyping from natural saliva components. | 100% concordant genotype calls for all samples and all endogenous substance conditions tested (salivary α-amylase, hemoglobin, immunoglobulin A, combination). |
| Interfering Substances (Exogenous): No impact on genotyping from common oral activities/substances. | 100% concordant genotype calls for all samples collected immediately after and 30 minutes after consuming exogenous substances (food, drinking, chewing gum, mouthwash) or smoking. |
| Consumer Usability/Comprehension (OTC Setting): Ability of naïve users to correctly collect samples and obtain sufficient DNA. | 98.3% of samples from 302 consumer study participants contained the minimum amount of DNA required for testing. User comprehension of test instructions was assessed. |
| Labeling Readability: Instructions are easily understood by general public. | Flesch-Kincaid reading grade level of 7.1 obtained for collection device labeling. |
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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