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510(k) Data Aggregation
(423 days)
ORAcollect®•Dx is intended for the collection of saliva samples for diagnostic testing of human DNA. Saliva samples may be collected by a healthcare professional or non-healthcare professional, such as a lay user. Saliva samples collected using ORAcollect®•Dx are stabilized and isolated for use in downstream diagnostic testing applications. Saliva samples collected using ORAcollect®•Dx can be transported and/or stored at ambient conditions.
ORAcollect® Dx family of collection devices offers reliable collection, transportation and longterm ambient temperature storage of human DNA from saliva. ORAcollect® • Dx devices are a minimally invasive alternative for collecting high quality and quantity DNA for use with prescription and over-the-counter (direct-to-consumer) diagnostic testing applications.
ORAcollect® • Dx consists of a collection tube containing a stabilizing liquid and a double ended cap with an integrated sponge used to collect a saliva sample. Using provided instructions for use, saliva collection can take place in a laboratory setting, physician's office, at home, 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. 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.
ORAcollect-Dx device pre-collection shelf life is 24 months at room temperature (15°C to 25°C) from the date of manufacture. Post collection, ORAcollect·Dx samples are stable at room temperature for up to 60 days. ORAcollect-Dx device and sample integrity are preserved during typical ambient transport and storage conditions.
ORAcollect®●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 ORAcollect®●Dx for their specific indications for use. Using DNA obtained from an ORAcollect®•Dx sample, laboratory testing is performed on genotyping systems or platforms in a CLIA (Clinical Laboratory Improvement Amendments) certified laboratory.
The provided text does not contain specific acceptance criteria with numerical thresholds or a detailed study description that directly proves the device meets those criteria in a standard "table of acceptance criteria and reported device performance" format.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Oragene®•Dx) and refers to various performance characteristics and previously evaluated studies (listed by k-number) that support the ORAcollect®•Dx device's performance.
However, based on the information provided, I can infer and summarize relevant details for each requested point:
1. A table of acceptance criteria and the reported device performance
Since explicit numerical acceptance criteria are not presented in the provided text, I will construct a table based on the discussed performance characteristics and the device's demonstrated suitability or equivalence. The "Reported Device Performance" will indicate that the device met the implied performance expectations by referring to the successful outcomes of the mentioned studies or equivalence claims.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reproducibility/Precision: Reliable collection of DNA. | Previously evaluated (K152464) and further demonstrated with FDA-cleared test systems (eSensor® Warfarin Sensitivity Saliva Test (K152612) and Progenika Biopharma A1AT Genotyping Test (K192858, k21115)). |
| Pre-collection Shelf-life: Stability for extended storage. | Stored for 24 months at ambient room temperature conditions or exposed to typical transport conditions with no significant impact on performance (supported by studies in K152464). |
| Post-collection Sample Stability: Maintain sample integrity. | Stable for 60 days at room temperature and stable upon exposure to typical transport conditions (e.g., -20°C to 50°C) (supported by studies in K152464). |
| Sampling Variability (User Study): Robustness to user error. | Demonstrated robustness of the collection device samples collected using varied methods, incorrect methods, or incorrect sites, even by naïve users or when instructions were not followed properly (evaluated in K152464). |
| Dry Mouth Effect: Performance in dry mouth conditions. | Effect of dry mouth on collected samples evaluated (K152464). (Implied: device performs adequately). |
| Human Factors: User compliance and ease of use. | User compliance to instructions and impact on sample performance, as well as areas of difficulty, evaluated (K152464). (Implied: acceptable user experience and performance). |
| Interfering Substances (Endogenous/Exogenous): No adverse effects on performance. | No observable effect on performance due to potentially interfering endogenous or exogenous substances when tested with eSensor® Warfarin Sensitivity Saliva Test (K152612) and Progenika Biopharma A1AT Genotyping Test (K192858). |
| Matrix Comparison: Equivalence across device models. | ORAcollect® Dx (OCD-100.014) is considered physically and chemically equivalent to OCD-100. Insert in OCD-100A does not affect performance (study data in K152464). |
| Method Comparison: Agreement with gold standard. | Genotyping results on eSensor® Warfarin Sensitivity Saliva Test compared favorably to "gold standard" bidirectional sequencing (K152612 and K192858). (Implied: adequate agreement). |
| Over-the-Counter (Direct-to-Consumer) Use: User comprehension and successful sample collection. | Donors demonstrated comprehension of instructions and successfully collected saliva samples acceptable for DTC use, as evidenced by user comprehension survey and physical characteristics of participant samples (study for AlphaID™ At Home Genetic Health Risk Service using OCD-100.014). |
2. Sample size used for the test set and the data provenance
The document references several previous 510(k) submissions (K152464, K152612, K192858, k21115, K221420) for the detailed studies. However, the exact sample sizes for the test sets in these underlying studies are not explicitly provided in this document.
For the "Over-the-Counter (Direct-to-Consumer) Use" study mentioned:
- Sample Size: "potential users enrolled in usability studies" and "each study sample" refers to participant samples, but no specific number is given.
- Data Provenance: The study involved users collecting samples "at home" and mailing them to a "CLIA certified laboratory" for assessment. This indicates prospective, real-world data collection in a consumer setting. No specific country of origin is mentioned, but DNA Genotek Inc. is based in Ottawa, Ontario, Canada, and the FDA review is for the U.S. market, suggesting a North American context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the text. The document refers to "genotyping systems or platforms in a CLIA certified laboratory" and comparison to "gold standard bidirectional sequencing" for method comparison, implying established laboratory procedures as the ground truth.
4. Adjudication method for the test set
This information is not provided in the text. Given the nature of the device (saliva collection kit for DNA), adjudication in the context of expert review of images or diagnoses is not directly applicable in the same way as for imaging AI. Instead, the "ground truth" would be established through laboratory analyses.
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
An MRMC comparative effectiveness study is not applicable to this device. This device is a saliva collection kit, not an AI algorithm assisting human readers in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical collection kit, not an algorithm. Its performance is evaluated on its ability to collect and stabilize DNA for subsequent laboratory testing, not on standalone interpretive capabilities.
7. The type of ground truth used
The ground truth for evaluating the ORAcollect®•Dx device's performance is primarily based on:
- Laboratory-based analytical results: DNA concentration, purity, and successful genotyping after extraction from the collected saliva.
- Comparison to "gold standard" methods: For instance, "gold standard bidirectional sequencing" for genotyping accuracy (as mentioned for method comparison studies in K152612 and K192858).
- Compliance and physical assessment: For the over-the-counter use, ground truth involved assessing compliance to collection instructions, sample volume, and DNA concentration by a CLIA-certified laboratory.
8. The sample size for the training set
The document describes performance evaluation (test-set like activities) rather than the development of an algorithm requiring a "training set." Therefore, information on the "training set" sample size is not applicable/provided.
9. How the ground truth for the training set was established
As explained in point 8, the concept of a "training set" for this type of device is not applicable. The ground truth is established through standard laboratory and analytical methods as detailed in point 7 for performance evaluation.
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