Who is the manufacturer of ORAcollect®Dx?

DNA Genotek, Inc. filed the 510(k) submission for ORAcollect®Dx (K212745).

What is the FDA product code for ORAcollect®Dx?

OYJ. It is classified under 21 CFR 862.1675 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for ORAcollect®Dx?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ORAcollect®Dx?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ORAcollect®Dx

K212745 · DNA Genotek, Inc. · OYJ · Oct 27, 2022 · Clinical Chemistry

Device Facts

Record ID	K212745
Device Name	ORAcollect®Dx
Applicant	DNA Genotek, Inc.
Product Code	OYJ · Clinical Chemistry
Decision Date	Oct 27, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1675
Device Class	Class 2

Intended Use

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.

Device Story

ORAcollect®•Dx is a non-invasive saliva collection device consisting of a tube with stabilizing liquid and a double-ended cap with an integrated sponge. Used by professionals or lay users in clinics, homes, or field settings. The sponge collects saliva; the stabilizing liquid lyses cellular/nuclear membranes to release and stabilize DNA upon mixing. Samples are stored/transported at ambient temperatures (up to 60 days post-collection). The device is used for downstream molecular diagnostic testing (e.g., genotyping) in CLIA-certified laboratories. Healthcare providers use the resulting genetic data to aid in clinical decision-making, such as assessing warfarin sensitivity, A1AT deficiency, or genetic health risks. The device benefits patients by providing a minimally invasive, stable method for remote sample collection, facilitating access to diagnostic testing.

Clinical Evidence

Clinical study evaluated lay-user collection (n=389, age 18+) in OTC setting. 387/389 (99.5%) samples yielded sufficient DNA. Genotyping call rate was 99.5% (first pass) and 99.7% (second pass), with 99.7% concordance to bi-directional sequencing. No bias observed regarding questionnaire completion. Labeling comprehension found acceptable.

Technological Characteristics

Non-sterile plastic collection tube with stabilizing liquid and integrated sponge cap. Stabilizing liquid lyses cells to release DNA. Ambient storage/transport. No electronic components. Manual operation.

Indications for Use

Indicated for collection and stabilization of human DNA from saliva for in vitro diagnostic germline testing in individuals 18 years of age and older. Not for RNA, protein, or hormone collection. Model OCD-100.014 is restricted to use with the AlphaID At Home Genetic Health Risk service.

Regulatory Classification

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.

Predicate Devices

Oragene®•Dx (k192920)

Related Devices

K152464 — ORAcollect.Dx · DNA Genotek, Inc. · May 26, 2016
K192920 — Oragene®Dx · DNA Genotek, Inc. · Jan 14, 2020
K110701 — ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 · DNA Genotek, Inc. · Dec 2, 2011
K152556 — Oragene Dx · DNA Genotek, Inc. · May 26, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 27, 2022 DNA Genotek Inc. Jonathan Chan Senior Regulatory Affairs Specialist 3000 - 500 Palladium Drive Ottawa, Ontario, K2V 1C2 Canada Re: K212745 Trade/Device Name: ORAcollect®•Dx Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: OYJ Dated: July 18, 2022 Received: July 21, 2022 Dear Jonathan Chan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR {1}------------------------------------------------ 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) k212745 Device Name ORAcollect®•Dx #### Indications for Use (Describe) ORAcollect®»Dx is intended for the collection of salva 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. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | Depository Use (Part 21 CFR 601 Subpart D) | | |-------------------------------------------------|-----------------------------------------| | Same-Tissue Controls Use (21 CFR 601 Subpart G) | ☒ | __ Prescription Use (Part 21 CFR 801 Subpart D) |X Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for DNA Genotek. The word "DNA" is in blue, and the word "genotek" is in black. Below the words is a series of gray and black rectangles that form a line. #### 510(k) Summary This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1900 and CFR 807.92. | Date: | 27 October 2022 | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | k212745 | | Submitter: | DNA Genotek Inc. 3000 – 500 Palladium Drive, Ottawa, Ontario K2V 1C2 Canada | | Contact: | Jonathan Chan, Senior Regulatory Affairs Specialist Tel: (613) 723-5757 Ext. 2438 Email: jonathan.chan@dnagenotek.com | | Device Proprietary Name Device models | ORAcollect®•Dx OCD-100, OCD-100A, OCD-100.014 | | Common names | Kit for collection of human DNA, Saliva kit, Sample collection kit for over- the-counter (direct-to-consumer) genetic testing use | | Proposed Device Regulatory Classification | Regulation: 21CFR 862.1675 Blood specimen collection device Panel: Chemistry (75) Classification: Class II Product Code: OYJ DNA Specimen Collection, Saliva | | Predicate Device | Oragene®•Dx (k192920) Regulation: 21CFR 862.1675 Blood specimen collection device Panel: Chemistry (75) Classification: Class II Product Code: OYJ DNA Specimen Collection, Saliva | #### Intended use 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. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for DNA Genotek. The word "DNA" is in blue, and the word "genotek" is in black. Below the words is a barcode. Indications for use See Intended Use, above. ## Special conditions for use statement - . ORAcollect®•Dx saliva samples can be self-collected. - ORAcollect®•Dx devices are intended for use in over-the-counter (direct-to-consumer) downstream diagnostic testing applications. - Test manufacturers must validate the use of ORAcollect®•Dx for their specific indications for use. - ORAcollect®●Dx is intended for collection and stabilization of human DNA from saliva, it is not intended for the collection and stabilization of RNA, protein, or hormones. - ORAcollect®●Dx has only been validated for use with germline testing. - For use in individuals 18 years of age and older. - ORAcollect® • Dx (OCD-100.014) device is intended for use (direct-to-consumer) use with AlphaID™ At Home Genetic Health Risk Service. ### DEVICE DESCRIPTION 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-thecounter (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. To date, ORAcollect®●Dx collection device performance has been established with the following FDA cleared test systems: ### eSensor® Warfarin Sensitivity Saliva Test (k152612) The eSensor® Warfarin Sensitivity Saliva Test is an in vitro diagnostic for the detection and genotyping of the *2 and *3 alleles of the cytochrome P450 (CYP450) 2C9 gene locus and the Vitamin K epoxide reductase C1 (VKORC1) gene promoter polymorphism (-1639G>A) from genomic DNA extracted from {5}------------------------------------------------ human saliva samples collected using the Oragene®·Dx and ORAcollect®·Dx devices, as an aid in the identification of patients at risk for increased warfarin sensitivity. For Prescription use only. ## Progenika Biopharma A1AT Genotyping Test (k192858, k211115) The Progenika A1AT genotyping kit is a quantitative, polymerase chain reaction (PCR) and hybridizationbased in vitro diagnostic test to be used with the Luminex 200 instrument (with xPONENT software) for the simultaneous detection and identification of 14 allelic variants and their associated alleles found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. The test intended for use with genomic DNA extracted from human whole blood samples collected as dry blood spot (DBS) or in K2-EDTA or from human saliva samples collected as buccal swabs using ORAcollect-Dx (OCD-100). The A1AT allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD). The kit is indicated for prescription use only. ## AlphaID™ At Home Genetic Health Risk Service (k221420) The AlphaID™ At Home Genetic Health Risk Service uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from human saliva collected from individuals ≥ 18 years old with the ORAcollect-Dx (OCD-100.014) for the purpose of reporting and interpreting genetic health risks. The service is intended to provide users with their genetic health risk linked to alpha-1antitrypsin deficiency (AATD). This information will help in their conversations with their healthcare professional. Note: ORAcollect®·Dx (OCD-100.014) is a physically and chemically equivalent custom version of ORAcollect® Dx (OCD-100). ORAcollect® Dx (OCD-100.014) and is intended for use in the collection of saliva samples. Human DNA from the saliva sample is isolated, stabilized, and suitable for over-the-counter use with the AlphalD™ At Home Genetic Health Risk Service. Saliva samples collected using ORAcollect Dx (OCD-100.014) are stabilized and can be transported and/or stored long-term at ambient conditions. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for DNA Genotek. The word "DNA" is in blue, and the word "genotek" is in black. Underneath the words is a dashed line. ## SUBSTANTIAL EQUIVALENCE INFORMATION The following table outlines the similarities and differences between the predicate and proposed device. | Principle, Materials and Technology | Oragene®•Dx (predicate device – k192920) | ORAcollect®•Dx (proposed device – K212745) | Similar | Different | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------| | Intended Use | 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 | 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. | X | | | Special conditions for use | Prescription and Over-the- counter use | Prescription and Over-the- counter use | X | | | Analyte | DNA | DNA | X | | | Sample collection | Non-invasive collection of biological samples delivered into a non-sterile plastic collection tube | Non-invasive collection of biological samples delivered into a non-sterile plastic collection tube | X | | | Formats/Models | Multiple: OGD-500, OGD- 510, OGD-575, OGD-600, OGD-610, OGD-675 | Multiple: OCD-100, OCD- 100A, OCD-100.014 | X | | | Principle, Materials and Technology | Oragene®•Dx (predicate device - k192920) | ORAcollect®•Dx (proposed device - k212745) | Similar | Different | | Tube material | Plastic | Plastic | X | | | Sample source | Human saliva | Human saliva | X | | | Additive | Nucleic acid stabilization solution | Nucleic acid stabilization solution | X | | | Transport and Stability | Pre-collection Oragene®•Dx kits can be transported at temperatures ranging from -20°C to 50°C | Pre-collection ORAcollect®•Dx kits can be transported at temperatures ranging from -20°C to 50°C | | X | | | Post-collection Oragene®•Dx samples can be transported at temperatures ranging from -20°C to 50°C | Post-collection ORAcollect®•Dx samples can be transported at temperatures ranging from -20°C to 50°C | | | | | Pre-collection Oragene®•Dx kits can be stored at room temperature for up to 30 months | Pre-collection ORAcollect®•Dx kits can be stored at room temperature for up to 24 months | | | | | Post-collection Oragene®•Dx samples can be stored at room temperature for up to 12 months | Post-collection ORAcollect®•Dx samples can be stored at room temperature for up to 60 days | | | | Performance and suitability for use with molecular diagnostic applications | Performance of stabilized DNA used in molecular diagnostic testing has been established in k110701, k141410, k152556. Suitability of standard Oragene®•Dx instructions for use in a typical over-the- counter (direct-to- consumer) setting has been established (k192920) | Performance of stabilized DNA used in prescription and over- the-counter(direct-to- consumer) molecular diagnostic testing has been established with eSensor® Warfarin Sensitivity Saliva Test (k152464, k152612). Progenika Biopharma A1AT Genotyping Test (k192858, k211115) AlphaID™ At Home Genetic Health Risk Service (k221420) | X | | | The similarities in intended use, materials, technological characteristics show that ORAcollect® •Dx (k212745) are substantially equivalent to the primary predicate Oragene®•Dx devices (k192920). The | | | | | | differences tabulated above do not affect the safety and performance of ORAcollect®•Dx devices. | | | | | #### Table 1. Comparison between Primary Predicate and Proposed devices {7}------------------------------------------------ {8}------------------------------------------------ #### PERFORMANCE CHARACTERISTICS ### Reproducibility/Precision The reproducibility of the ORAcollect®●Dx (device models: OCD-100A) collection device has been previously evaluated (see k152464). In addition, analytical precision of ORAcollect® Dx collection device has been further demonstrated with the following FDA cleared test systems eSensor® Warfarin Sensitivity Saliva Test (k152612) and Progenika Biopharma A1AT Genotyping Test (k192858, k21115). #### Stability #### Pre-collection shelf-life Pre-collection shelf-life of ORAcollect® Dx devices has been previously evaluated and demonstrated (see k152464). ORAcollect®●Dx (device models: OCD-100) formats are FDA cleared and have of the same physical and chemical components including their instructions for use. Studies in k152464 supports that ORAcollect Dx devices can be stored for 24 months at ambient, room temperature conditions or exposed to typical transport conditions, with no significant impact on performance. #### Post-collection sample stability Post-collection sample stability of ORAcollect® Dx devices has been previously demonstrated (see k152464). ORAcollect®®Dx (device models: OCD-100) formats are FDA cleared and have of the same physical and chemical components including their instructions for use. Studies in k152464 supports that ORAcollect Dx sample stability of 60 days at room temperature and stability upon exposure to conditions expected during typical transport (i.e. transient exposure to temperatures between -20°C and 50°C. ### Detection Limit ### User Study The effects of sampling variability due to user collection error, incorrect collection methods and collection from an incorrect site were previously evaluated in k152464. Study data demonstrated the robustness of the ORAcollect Dx collection device samples collected using the varied collected methods, incorrect collection methods or incorrect collection site even in the hands of naive users and/or when instructions for use are not followed properly. ### Dry Mouth Study The effect of dry mouth on the samples collected using the ORAcollect·Dx device was evaluated in k152464. #### Human Factors User compliance to ORAcollect® Dx collection instructions and its impact on sample performance, as well as to identify areas of difficulty in the collection procedure was evaluated in k152464. #### Limit of Detection For limit of detection on Progenika Biopharma A1AT Genotyping Test, see k21115. {9}------------------------------------------------ ## Interfering Substances ## Endogenous Substances The effect of potentially interfering endogenous substances on performance of saliva samples collected with the ORAcollect® Dx device has been successfully demonstrated with the following FDA cleared test systems eSensor® Warfarin Sensitivity Saliva Test (k152612) and Progenika Biopharma A1AT Genotyping Test (k192858). There was no observable effect to performance of any of the potentially interfering endogenous substances. ## Exogenous Substances The effect of potentially interfering exogenous substances on the performance of saliva samples collected with the ORAcollect®.Dx devices have been demonstrated with the following FDA cleared test systems eSensor® Warfarin Sensitivity Saliva Test (k152612) and Progenika Biopharma A1AT Genotyping Test (k192858). There was no observable effect to performance of any of the potentially interfering exogenous substances. ## Comparison Studies ## Matrix Comparison ORAcollect® Dx is available in equivalent and identical formats OCD-100 and OCD-100A. The OCD-100A format includes a molded plastic insert inside the collection tube. The insert is intended to facilitate or enable a more efficient physical handling of the sample in the laboratory but has no impact on sample collection. Study data in k152464 indicates that the insert present in the OCD-100A format does not affect the performance of the device. ORAcollect® Dx (OCD-100.014) is a physically and chemically equivalent custom version of ORAcollect® Dx OCD-100.014 and is intended for use in the collection of saliva samples. Human DNA from the saliva sample is isolated, stabilized, and suitable for over-the-counter use with the AlphalD™ At Home Genetic Health Risk Service. Saliva samples collected using ORAcollect-Dx (OCD-100.014) are stabilized and can be transported and/or stored long-term at ambient conditions. ## Method Comparison Method comparison studies have been previously evaluated in k152612 and k192858. Genotyping results on the eSensor Warfarin Sensitivity Saliva Test were compared to results from the 'gold standard' bidirectional sequencing in order to assess performance. ## Over-the-Counter (Direct-to-Consumer) Use Performance of saliva samples collected with ORAcollect® Dx (device model OCD-100.014) when used in an over-the-counter (direct-to-consumer) setting. The objective of the study was to demonstrate that donors comprehend the instructions for use provided with the ORAcollect®·Dx device and can successfully collect saliva samples acceptable for use in an over-the-counter (direct-to-consumer) setting. ORAcollect•Dx collection device was provided as part of the AlphalD™ Saliva Collection Kit which is intended to be used with the AlphalD™ At Home Genetic Health Risk Service. Specifically, potential users enrolled in usability studies collected saliva samples at home using standard ORAcollect®●Dx devices instructions and mailed them to a testing laboratory as is typical in {10}------------------------------------------------ a direct-to- consumer setting. Upon receipt at a certified CLIA testing laboratory, each study sample was assessed for compliance to collection instructions and sample volume, DNA concentration. The results of the user comprehension survey and the physical characteristics of the participant samples demonstrated that the ORAcollect® Dx collection device can be used successfully in the direct-toconsumer setting. ### CONCLUSION The results from the studies submitted in this premarket notification are complete and demonstrate that the ORAcollect®●Dx device is substantially equivalent to the predicate device. The submitted information supports the use of the ORAcollect®●Dx devices for prescription and over-the-counter (direct-to-consumer) use with FDA cleared and legally marketed molecular diagnostics applications.