(261 days)
No
The summary describes a device for collecting and stabilizing saliva samples for DNA analysis. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML. The focus is on the physical and chemical properties of the collection device and the stability of the collected DNA.
No
This device is for the collection and stabilization of saliva samples for diagnostic applications, not for treating any condition.
No
The device is intended for the non-invasive collection and stabilization of saliva samples, which are then used in FDA cleared molecular diagnostic applications. It is a collection device, not a diagnostic one itself.
No
The device is a saliva collection kit consisting of physical components (collection tube, stabilizing liquid, optional sponges) and is not solely software.
Based on the provided text, the Oragene Dx device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the collected DNA is "suitable for use in FDA cleared molecular diagnostic applications." This directly links the device to diagnostic purposes.
- Device Description: The description mentions that the device is used for collecting DNA "for use in molecular diagnostic applications."
- Performance Studies: The performance studies section details evaluations related to reproducibility, shelf life, stability, detection limit, interfering substances, and comparison studies, all of which are typical for IVD devices to demonstrate their suitability for diagnostic use.
- Predicate Device: The predicate device listed (K110701) is also an Oragene-Dx device, and the text refers to it as "FDA cleared Oragene-Dx formats," further indicating its regulatory status as an IVD.
- Reference Device: The reference device (K110786) is the "eSensor® Warfarin Sensitivity Saliva Test," which is a molecular diagnostic test that would utilize the DNA collected by the Oragene Dx device.
While the device itself is a sample collection and stabilization device, its intended use and the context provided clearly place it within the realm of in vitro diagnostics as a crucial component for downstream diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes
OYJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Saliva collection can take place at home, in a laboratory setting, physician's office, or in the field by untrained (naïve) or professional users.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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: 24 months at room temperature, 12 months at -20±5°C and 6±4°C.
Post-collection sample stability: 12 months at room temperature, -20±5°C or 6±4°C, 3 months at 50±5°C.
Detection Limit - Sample Volume Tolerance: The effect of overfilling or underfilling the Oragene Dx device has been demonstrated; see section 18.2 of K110701. 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. DNA yield 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. 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, provided donor collection instructions (no eating, drinking, smoking, or chewing gum 30 minutes prior to saliva collection) were followed.
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. 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1675 Blood specimen collection device.
(a)
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.(b)
Classification. Class II.
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)
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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.
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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
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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.