Who is the manufacturer of Oragene Dx?

DNA Genotek, Inc. filed the 510(k) submission for Oragene Dx (K152556).

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).

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

K152556 · DNA Genotek, Inc. · OYJ · May 26, 2016 · Clinical Chemistry

Device Facts

Record ID	K152556
Device Name	Oragene Dx
Applicant	DNA Genotek, Inc.
Product Code	OYJ · Clinical Chemistry
Decision Date	May 26, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1675
Device Class	Class 2

Intended Use

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.

Device Story

Oragene-Dx is a non-invasive saliva collection system consisting of a plastic tube containing a DNA-stabilizing liquid and optional sponges. Users provide saliva samples via direct spitting or sponge transfer. Upon contact, the stabilizing liquid lyses cellular and nuclear membranes to release and stabilize DNA. The device is used in homes, clinics, or laboratories by patients or professionals. Stabilized samples are transported at ambient temperatures to laboratories for molecular diagnostic processing. The device enables long-term storage (up to 12 months post-collection) and maintains sample integrity for downstream analysis, facilitating clinical decision-making based on molecular diagnostic test results.

Clinical Evidence

No clinical trials performed. Evidence based on bench testing and analytical performance validation. Studies compared subject devices to predicate (K110701) using the eSensor Warfarin Sensitivity Saliva Test. Results showed 100% agreement between genotyping and bidirectional sequencing. Performance parameters (DNA concentration, yield, A260/A280 ratio) met acceptance criteria and showed no significant differences compared to the predicate.

Technological Characteristics

Non-invasive saliva collection system; plastic collection tube; chemical DNA stabilization solution (lysing agent). Dimensions/volumes vary by format. Standalone device; no energy source. Shelf life: 24 months pre-collection at room temperature; 12 months post-collection stability at room temperature.

Indications for Use

Indicated for non-invasive collection of human saliva samples for DNA isolation and stabilization for use in FDA-cleared molecular diagnostic applications. Suitable for use by professional or untrained users in home, laboratory, physician office, or field settings.

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 OGD-500 (K110701)

Reference Devices

eSensor® Warfarin Sensitivity Saliva Test (K110786)

Related Devices

K110701 — ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500 · DNA Genotek, Inc. · Dec 2, 2011
K192920 — Oragene®Dx · DNA Genotek, Inc. · Jan 14, 2020
K152464 — ORAcollect.Dx · DNA Genotek, Inc. · May 26, 2016
K212745 — ORAcollect®Dx · DNA Genotek, Inc. · Oct 27, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 26, 2016 DNA GENOTEK, INC. DAN FULLERTON 2 BEAVERBROOK ROAD OTTAWA, ONTARIO K2K 1L1 CANADA Re: k152556 Trade/Device Name: Oragene®Dx OGD-510. Oragene®Dx OGD-600. Oragene®Dx OGD-610, Oragene®Dx OGD-675 Regulation Number: 21 CFR §862.1675 Regulation Name: Blood specimen collection device Regulatory Class: II Product Code: OYJ Dated: April 19, 2016 Received: April 21, 2016 Dear Mr. Fullerton: 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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, ## Courtney H. Lias -S Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K152556 Device Name Oragene Dx: OGD-510; OGD-600; OGD-610; OGD-675 Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) 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}------------------------------------------------ ## 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: | 18 April 2016 | |-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | DNA Genotek Inc. 3000 – 500 Palladium Drive, Ottawa, Ontario K2V 1C2 Canada | | Contact: | Dan Fullerton Vice President Operations, Quality & Regulatory Affairs Tel: (613) 723-5757 Ext. 213, Fax: (613) 368-4628 Email: dan.fullerton@dnagenotek.com | | Device Proprietary Name | Oragene®•Dx Format: OGD-510, OGD-600, OGD-610, OGD-675 | | Common names | Kit for collection of human DNA, Saliva kit, Sample collection kit | | 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 Regulatory Classification | Oragene·Dx OGD-500 (k110701) Regulation: 21CFR 862.1675 Blood specimen collection device Panel: Chemistry (75) Classification: Class II Product Code: OYJ DNA Specimen Collection, Saliva | ## INTENDED USE ## Intended use 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. ## Indications for use See Intended Use, above. ## Special conditions for use statement For prescription use. {4}------------------------------------------------ ## DEVICE DESCRIPTION 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. ## SUBSTANTIAL EQUIVALENCE INFORMATION | Principle, Materials and Technology | Predicate devices Oragene·Dx: OGD-500, OGD-575, OYD-500, OXD-500 (k110701) | Subject devices Oragene·Dx: OGD-510, OGD- 600, OGD-610, OGD-675 | 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 | Same as predicate | X | | | Principle, Materials and Technology | Predicate devices | Subject devices | Similar | Different | | | Oragene-Dx: OGD-500, OGD-575, OYD-500, OXD-500 (k110701) | Oragene-Dx: OGD-510, OGD- 600, OGD-610, OGD-675 | | | | | and can be transported and/or stored long term at ambient conditions. | | | | | Special conditions for use | Prescription | Same as predicate | X | | | Analyte | Human DNA | Same as predicate | X | | | Device physical design | Consists of a collection tube, a DNA stabilizing liquid and optional sponges for assisted collection. | Same as predicate | X | | | Sample collection | Non-invasive collection of biological samples delivered into a non-sterile plastic collection tube | Same as predicate | X | | | Instructions for use | Multiple languages | English only (except OGD- 510) | | X | | Formats | Multiple | Same as predicate | X | | | Tube material | Plastic | Same as predicate | X | | | Sample source | Human saliva | Same as predicate | X | | | Additive | Nucleic acid stabilization solution | Same as predicate | 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 24 months 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 | Same as predicate | X | | | Principle, Materials and Technology | Predicate devices Oragene-Dx: OGD-500, OGD-575, OYD-500, OXD-500 (k110701) | Subject devices Oragene-Dx: OGD-510, OGD-600, OGD-610, OGD-675 | Similar | Different | | Performance | Performance has been established with the eSensor® Warfarin Sensitivity Saliva Test | Same as predicate | X | | The following table outlines the similarities and differences between predicate and subject devices. {5}------------------------------------------------ # DNA genotek ================================================================================================================================================================== {6}------------------------------------------------ The similarities in intended use, materials, technological characteristics show that Oragene Dx devices OGD-510, OGD-600, OGD-610, OGD-675 are substantially equivalent to Oragene Dx devices (k110701). The difference tabulated above does not affect the safety and performance of the device. Oragene-Dx device performance has been validated using GenMark Diagnostics' FDA cleared eSensor Warfarin Sensitivity Saliva Test (k110786). ## PERFORMANCE CHARACTERISTICS ## REPRODUCIBILITY/PRECISION The reproducibility of the Oragene-Dx devices has been demonstrated; see section 18.4 of k110701. Two reproducibility studies were performed and evaluated device reproducibility using prepared sample panels and the reproducibility of sample collection, processing and testing procedures. Overall, all samples tested met study acceptance criteria. ## SHELF LIFE AND STABILITY ## Pre-collection shelf-life Shelf-life stability testing of the Oragene Dx device has been demonstrated; see Section 18.3 of k110701. Oragene-Dx formats OGD-510, OGD-600, OGD-610 and OGD-675 are comprised of the same physical and chemical components as the FDA cleared Oragene·Dx formats; therefore, studies in k110701 support the following shelf-life performance claims: - 24 months at room temperature - . 12 months at -20±5°C and 6±4°C ## Post-collection sample stability Post-collection sample stability of the Oragene-Dx devices has been demonstrated; see Section 18.3 of k110701. The Oragene Dx formats OGD-510, OGD-600, OGD-610 and OGD-675 are comprised of the same physical and chemical components as the FDA cleared Oragene Dx formats; therefore, studies in k110701 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 {7}------------------------------------------------ ## DETECTION LIMIT ## Sample Volume Tolerance The effect of overfilling or underfilling the Oragene Dx device has been demonstrated; see section 18.2 of k110701. Oragene-Dx formats OGD-510, OGD-600, OGD-675 are comprised of the same physical and chemical components as the FDA cleared Oragene Dx formats. 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 vield was dependent on collected volume, but downstream performance was not affected by over or under spitting. ## INTERFERING SUBSTANCES The effect of endogenous and exogenous interfering substances has been demonstrated; see Section 18.6 of K110701. The Oragene-Dx formats OGD-510, OGD-610 and OGD-675 are comprised of the same physical and chemical components as the FDA cleared Oragene-Dx formats. In summary, in accordance with the donor collection instructions for use that specify no eating, drinking, smoking , or chewing gum 30 minutes prior to saliva collection this study demonstrates that there was no impact on performance from the introduction of either endogenous substances or exogenous substances into Oragene Dx saliva samples tested had 100% agreement between eSensor® Warfarin Sensitivity Test genotyping and bidirectional sequencing. ## COMPARISON STUDIES Matrix comparison was evaluated in k110701; see Section 18.5. Method comparison studies were previously completed with the eSensor Warfarin Sensitivity Saliva Test; see K110786. The Oragene-Dx formats OGD-510, OGD-600, OGD-610 and OGD-675 are comprised of the same physical and chemical components as the FDA cleared Oragene-Dx formats, therefore these comparison studies are applicable. A new study was conducted to evaluate the analytical performance of OGD-510 (DNA concentration, yield, A260/A280 ratio and agreement between genotyping on the eSensor Warfarin Sensitivity Saliva Test and bidirectional sequencing), and performance was compared to that of OGD-500. This study is also applicable to OGD-610 as it is an equivalent format to OGD-510. Overall, 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. There was no significant difference in any performance parameters (with the expected exception of total sample DNA yield) between the two formats. ## CONCLUSION The submitted information in this premarket notification is complete and supports the safety and effectiveness of the Oragene-Dx OGD-510, OGD-600, OGD-610 and OGD-675 formats and substantial equivalence to the predicate devices (Oragene-Dx K110701). As established in k110701 and in this submission, the difference in the formats of the subject Oragene Dx devices conferred no differences in the performance of the stabilized and/or purified DNA.