Who is the manufacturer of Oragene®Dx?

DNA Genotek, Inc. filed the 510(k) submission for Oragene®Dx (K192920).

What is the FDA product code for Oragene®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 Oragene®Dx?

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

What are the predicate devices for Oragene®Dx?

Oragene®•Dx Collection Device, models OGD-500; OGD-575; OXD-525; OYD-500 (K110701).

Who can help prepare an FDA 510(k) submission like Oragene®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.

Oragene®Dx

K192920 · DNA Genotek, Inc. · OYJ · Jan 14, 2020 · Clinical Chemistry

Device Facts

Record ID	K192920
Device Name	Oragene®Dx
Applicant	DNA Genotek, Inc.
Product Code	OYJ · Clinical Chemistry
Decision Date	Jan 14, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1675
Device Class	Class 2

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.

Device Story

Oragene®•Dx is a non-invasive saliva collection device for human DNA. It consists of a collection tube with a funnel lid containing a stabilizing liquid. Users expectorate saliva directly into the tube or use an optional sponge for assisted collection. Upon contact, the stabilizing liquid lyses cellular and nuclear membranes to release and stabilize nucleic acids. The device allows for transport and long-term storage at ambient conditions. It is used in clinical or home settings by healthcare professionals or lay users. The stabilized sample is subsequently used in downstream molecular diagnostic applications. The device benefits patients by providing a non-invasive alternative to blood collection for DNA-based testing.

Clinical Evidence

No clinical diagnostic data. A lay-user study (n=206) evaluated collection and labeling comprehension for the OGD-610 model. 97.35% of samples met minimum DNA requirements for testing; 98.41% after re-extraction. Results demonstrate that lay users can follow instructions to obtain adequate samples in an OTC setting.

Technological Characteristics

Non-sterile plastic collection tube with funnel lid and stabilizing liquid. Principle: chemical lysis and stabilization of nucleic acids. Dimensions/form factor: tube-based. Connectivity: N/A. Sterilization: N/A. Software: None.

Indications for Use

Indicated for non-invasive collection of human saliva samples for in vitro diagnostic testing of human DNA. Suitable for use by healthcare professionals or lay users (OTC).

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 Collection Device, models OGD-500; OGD-575; OXD-525; OYD-500 (K110701)

Reference Devices

eSensor® Warfarin Sensitivity Saliva Test (k110786)
23andMe PGS (DEN140044)
23andMe PGS (DEN160026)
Akonni TruDiagnosis® System (k183530)

Related Devices

K152556 — Oragene Dx · DNA Genotek, Inc. · May 26, 2016
K110701 — ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 · DNA Genotek, Inc. · Dec 2, 2011
K212745 — ORAcollect®Dx · DNA Genotek, Inc. · Oct 27, 2022
K152464 — ORAcollect.Dx · DNA Genotek, Inc. · May 26, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. January 14, 2020 DNA Genotek Inc. Austin Udocor Senior Regulatory Affairs Manager 3000 - 500 Palladium Drive Ottawa, Ontario K2V 1C2 Canada Re: K192920 Trade/Device Name: Oragene®•Dx Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: OYJ Dated: October 11, 2019 Received: October 16, 2019 ## Dear Austin Udocor: 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 {1}------------------------------------------------ 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 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 medical devices and radiation-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, Marianela Perez-Torres, Ph.D. Acting Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) k192920 Device Name Oragene®•Dx ### Indications for Use (Describe) 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 Type of Use (Select one or both, as applicable) | | 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 resemble a barcode. ### 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: | 14 January 2020 | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | k192920 | | Submitter: | DNA Genotek Inc. 3000 – 500 Palladium Drive, Ottawa, Ontario K2V 1C2 Canada | | Contact: | Austin Udocor, Senior Regulatory Affairs Manager Tel: (613) 723-5757 Ext. 2245, Fax: (613) 368-4628 Email: austin.udocor@dnagenotek.com | | Device Proprietary Name Device models | Oragene®.Dx OGD-500, OGD-510, OGD-575, OGD-600, OGD-610, OGD-675 | | 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 (k110701) Regulation: 21CFR 862.1675 Blood specimen collection device Panel: Chemistry (75) Classification: Class II Product Code: OYJ DNA Specimen Collection, Saliva | | Additional Predicate Devices | Oragene®.Dx (k141410, k152556) Regulation: 21CFR 862.1675 Blood specimen collection device Panel: Chemistry (75) Classification: Class II Product Code: OYJ DNA Specimen Collection, Saliva | ### 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. {4}------------------------------------------------ Image /page/4/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 squares. ### Indications for use See Intended Use, above. ### Special conditions for use statement - Oragene®●Dx saliva samples can be self-collected or collected with assistance. - . Oragene®®Dx devices are intended for use in prescription and over-the-counter (direct-toconsumer) downstream diagnostic testing applications. - . Test manufacturers must validate the use of Oragene®●Dx for their specific indications for use. ### DEVICE DESCRIPTION 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. To date, Oragene® Dx collection device performance has been established with the following FDA cleared test systems: ### eSensor® Warfarin Sensitivity Saliva Test (k110786) The eSensor® Warfarin Sensitivity Saliva Test is an in vitro diagnostic test 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 of human saliva samples collected using the Oragene®●Dx Device, as an aid in the identification of patients at risk for increased warfarin sensitivity. For Prescription use only. {5}------------------------------------------------ |||||||||||||||||| ### 23andMe PGS (DEN140044, DEN160026) The 23andMe PGS Carrier Screening Test for Bloom Syndrome is indicated for the detection of the BLMAsh variant in the BLM gene from saliva collected using an FDA cleared collection device (Oragene®•Dx model OGD-500.001). This test can be used to determine carrier status for Bloom syndrome in adults of reproductive age, but cannot determine if a person has two copies of the BLMAsh variant. The test is most relevant for people of Ashkenazi Jewish descent. The 23andMe Personal Genome Service (PGS) Test uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from human saliva collected from individuals ≥18 years with the Oragene®●Dx model OGD-500.001 for the purpose of reporting and interpreting Genetic Health Risks (GHR). For over-the-counter use. ### Akonni TruDiagnosis® System (k183530) The TruDiagnosis® System is an in vitro diagnostic device intended for processing and genotyping multiple genetic variants in a DNA sample utilizing on-slide PCR gel-drop microarray technology. The TruDiagnosis® System consists of the TruDx® 2000 Imager, the TruArray® Warfarin Sensitivity Test Kit, and the ProFlex™ PCR System using the ProFlex™ 2x Flat Sample Block. The TruDx® 2000 Imager is an instrument intended for processing and genotyping multiple genetic variants in a DNA sample utilizing on-slide PCR gel-drop microarray technology. The TruArray® Warfarin Sensitivity Test Kit is an in vitro diagnostic test for the detection and genotyping of the 2C9*2, 2C9*3 alleles of the cytochrome P450 (CYP450) 2C9 gene locus and Vitamin K epoxide reductase Cl, VKORCl, gene promoter polymorphism (-1639) from genomic DNA of human saliva samples collected using the Oragene® Dx Device (OGD-500) as an aid in the identification of patients at risk for increased warfarin sensitivity. The TruArray® Warfarin Sensitivity Test Kit is a qualitative assay for use in clinical laboratories upon prescription by the attending physician. For Prescription use. {6}------------------------------------------------ Image /page/6/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 squares. ### SUBSTANTIAL EQUIVALENCE INFORMATION The following table outlines the similarities and differences between the predicate and proposed device. | Principle, Materials and Technology | Oragene®•Dx (predicate - k110701) | Oragene®•Dx (proposed devices – K192920) | Similar | Different | |-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------| | Intended Use | 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 | 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 | | × | | Special conditions for use | Prescription use only | Prescription and Over-the- counter use | | × | | 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-575 | Multiple: OGD-500, OGD- 510, OGD-575, OGD-600, OGD-610, OGD-675 | X | | | Principle, Materials and Technology | Oragene®•Dx (predicate - k110701) | Oragene®•Dx (proposed devices – K192920) | 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 Post-collection Oragene®•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 Oragene®•Dx kits can be transported at temperatures ranging from -20°C to 50°C Post-collection Oragene®•Dx samples can be transported at temperatures ranging from -20°C to 50°C | X | | | | Post-collection Oragene®•Dx samples can be stored at room temperature for up to 12 months (OGD-500, OGD-575, OYD-500) and 3 months for OXD-525 | Pre-collection Oragene®•Dx kits can be stored at room temperature for up to 30 months Post-collection Oragene®•Dx samples can be stored at room temperature for up to 12 months | | | | Performance and suitability for use with molecular diagnostic applications | Stabilized DNA can be used in molecular diagnostic testing; e.g., • Performance has been established with the eSensor® Warfarin Sensitivity Saliva Test. | 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) | X | | | Principle, Materials and Technology | Oragene®•Dx (additional predicate: k141410, k152556) | Oragene®•Dx (proposed devices - k192920) | Similar | Different | | Intended Uses | Prescription (k152556): Oragene®•Dx is 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 Over-the-counter (k141410): 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 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 | X | | | Principle, | Oragene®•Dx | Oragene®·Dx | Similar | Different | | Materials and Technology | (additional predicate: k141410, k152556) | (proposed devices - k192920) | | | | Special conditions for use | Over-the-counter and prescription use | Prescription or Over-the- counter use | × | | | Analyte | DNA | DNA | × | | | 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 | × | | | Formats/Models | Multiple: OGD-500.001, OGD- 510, OGD-600, OGD-610, OGD-675 | Multiple: OGD-500, OGD 510, OGD-575, OGD 600, OGD 610, OGD-675 | × | | | Tube material | Plastic | Plastic | × | | | Sample source | Human saliva | Human saliva | × | | | Additive | Nucleic acid stabilization solution | Nucleic acid stabilization solution | × | | | Transport and Stability | Pre-collection Oragene®•Dx kits can be transported at temperatures ranging from -20°C to 50°C Post-collection Oragene®•Dx | Pre-collection Oragene®•Dx kits can be transported at temperatures ranging from -20°C to 50°C | × | | | | samples can be transported at temperatures ranging from -20°C to 50°C Pre-collection Oragene®•Dx | Post-collection Oragene®•Dx samples can be transported at temperatures ranging from -20°C to 50°C | | | | | kits can be stored at room temperature for up to 30 months Post-collection Oragene®•Dx samples can be stored at room | Pre-collection Oragene®•Dx kits can be stored at room temperature for up to 30 months | | | | | temperature for up to 12 months (OGD-500, OGD-575, OYD-500) and 3 months for OXD-525 | Post-collection Oragene®•Dx samples can be stored at room temperature for up to 12 months | | | | Principle, Materials and Technology | Oragene®•Dx (additional predicate: k141410, k152556) | Oragene®•Dx (proposed devices - k192920) | Similar | Different | | Performance and suitability for use with molecular diagnostic applications | Stabilized DNA can be used in molecular diagnostic testing; e.g., Performance has been established with the eSensor® Warfarin Sensitivity Saliva Test. Performance has been established with the 23andMe Personal Genome Service | 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) | X | | Table 1. Comparison between Primary Predicate and Proposed devices {7}------------------------------------------------ The similarities in intended use, materials, technological characteristics show that Oragene®●Dx (k192920) are substantially equivalent to the primary predicate Oragene®●Dx devices (k110701). The differences tabulated above do not affect the safety and performance of Oragene®●Dx devices. {8}------------------------------------------------ # DNA GENOTEK MELL E E E E BERE E E E BEE E BEEL E BEELE E ## Table 2. Comparison between Additional Predicate and Proposed devices {9}------------------------------------------------ # DNA GENOTEK ■・・・・・■■・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ {10}------------------------------------------------ The similarities in intended use, materials, technological characteristics show that Oragene® Dx (k192920) are substantially equivalent to the additional predicate Oragene®•Dx devices (k1410, k152556). The differences tabulated above do not affect the safety and performance of Oragene® •Dx devices. ### PERFORMANCE CHARACTERISTICS ## Reproducibility/Precision The reproducibility of the Oragene®●Dx (device models: OGD-500, OGD-510, OGD-600, OGD-610) collection device has been evaluated (see k110701, k152556). In addition, analytical precision of Oragene®•Dx collection device has been further demonstrated with the following FDA cleared test systems eSensor® Warfarin Sensitivity Saliva Test (k110786), 23andMe PGS (DEN140044, DEN160026) and Akonni TruDiagnosis® System (k183530). ## Stability ## Pre-collection shelf-life Shelf-life stability testing of the Oragene®●Dx device has been demonstrated (see k110701, k152556). The Oragene®®Dx (device models: OGD-500, OGD-510, OGD-575, OGD-600, OGD-610, OGD-675) formats are FDA cleared and have of the same physical and chemical components including their instructions for use. Studies in k110701 and k152556 support the following shelf-life performance claims: - . 30 months at room temperature - 12 months at -20±5°C and 6±4°C ● {11}------------------------------------------------ ### Post-collection sample stability Post-collection sample stability of the Oragene®●Dx (device model: OGD-500) has been demonstrated in studies evaluating DNA yield, DNA concentration, A260/A280 ratio and microbial content (see k110701). The Oragene®•Dx format is comprised of the same physical and chemical components as the FDA cleared Oragene®●Dx OGD-500 format; therefore, studies in k110701, k152556 support the following sample stability performance claims: - 12 months at room temperature, -20±5°C or 6±4°C ● - . 3 months at 50±5°C ### Sample Volume Tolerance The effect of overfilling or underfilling the Oragene®●Dx device has been evaluated (see k110701). Oragene® • Dx device models are comprised of the same physical and chemical components as the FDA cleared Oragene®●Dx OGD-500 format. As demonstrated, underfilling the Oragene®●Dx device (OGD-500) by 25% or 50% of target volume, or overfilling by 50% of target volume did not impact performance. Collected samples ranged from as low as 0.58mL saliva to as much as 3.64 mL saliva. As expected, the DNA yield was dependent on collected volume, but downstream performance was not affected by over or under spitting. In addition, sample volume tolerance of the Oragene®•Dx collection device has been further demonstrated with the following FDA cleared test systems eSensor® Warfarin Sensitivity Saliva Test (k110786), 23andMe PGS (DEN140044, DEN160026) and Akonni TruDiagnosis® System (k183530). ### Interfering Substances ### Endogenous Substances The effect of potentially interfering endogenous substances on performance of saliva samples collected with the Oragene®®Dx device has been successfully demonstrated with the following FDA cleared test systems eSensor® Warfarin Sensitivity Saliva Test (k110786), 23andMe PGS (DEN140044, DEN160026), and Akonni TruDiagnosis® System (k183530). 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 Oragene®●Dx devices have been demonstrated with the following FDA cleared test systems eSensor® Warfarin Sensitivity Saliva Test (k110786), 23andMe PGS (DEN140044, DEN160026), and Akonni TruDiagnosis® System (k183530).There was no observable effect to performance of any of the potentially interfering exogenous substances. {12}------------------------------------------------ ### Over-the-Counter (Direct-to-Consumer) Use Performance of saliva samples collected with custom Oragene®®Dx (device model OGD-500.001) when used in an over-the-counter (direct-to-consumer) setting was previously evaluated with 23andMe PGS (k141410, DEN140044). In addition, a user comprehension study using standard Oragene® · Dx devices (k192920) when used in a simulated over-the-counter (direct-to-consumer) setting…

Oragene®Dx

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Oragene®Dx

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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