(90 days)
No
The device is a saliva collection kit and does not perform any analysis or processing that would typically involve AI/ML.
No.
The device is described as a collection device for saliva samples for in vitro diagnostic testing, not for therapeutic purposes. It is used to collect and stabilize DNA from saliva for diagnostic applications.
No
This device is a saliva collection kit designed for use with in vitro diagnostic testing, not a diagnostic device itself. It collects and stabilizes DNA from saliva samples for downstream diagnostic applications.
No
The device description clearly outlines physical components (collection tube, funnel lid, stabilizing liquid, small cap) and their function in collecting, stabilizing, and storing saliva samples. This is a hardware device for sample collection.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for in vitro diagnostic testing of human DNA." This is a key indicator of an IVD.
- Device Description: The description mentions that the collected DNA is for "use with prescription and over-the-counter (direct-to-consumer) diagnostic testing applications." It also states that the resulting genetic information "may be used by medical and health practitioners as an aid in patient management," which is a diagnostic purpose.
- Downstream Use: The device is designed to collect and stabilize samples for use in downstream diagnostic testing applications, systems, or platforms.
- Regulatory Context: The document mentions validation with FDA cleared test systems and use in CLIA certified laboratories, which are contexts relevant to IVDs.
While the device itself is a sample collection and stabilization tool, its intended purpose is to provide a sample suitable for in vitro diagnostic testing. Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OYJ
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-the-counter (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Saliva
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Saliva samples may be collected by a healthcare professional or non-healthcare professional, such as a lay user. 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Stability (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). 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). 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. Sample volume tolerance has been further demonstrated with 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 eSensor® Warfarin Sensitivity Saliva Test (K110786), 23andMe PGS (DEN140044, DEN160026), and Akonni TruDiagnosis® System (K183530). There was no observable effect to performance.
Interfering 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 eSensor® Warfarin Sensitivity Saliva Test (K110786), 23andMe PGS (DEN140044, DEN160026), and Akonni TruDiagnosis® System (K183530). There was no observable effect to performance.
Over-the-Counter (Direct-to-Consumer) Use: Performance of saliva samples collected with custom Oragene®®Dx (device model OGD-500.001) in an over-the-counter (direct-to-consumer) setting was previously evaluated with 23andMe PGS (K141410, DEN140044). A user comprehension study using standard Oragene® · Dx devices (K192920) in a simulated over-the-counter (direct-to-consumer) setting was completed. This usability study evaluated user comprehension and compliance to the standard Oragene® -Dx device Instructions for Use (IFU). Objectives: 1. To evaluate if study participants can correctly perform the sample collection through management of physical sample parameters (volume, compliance, DNA concentration, test performance/call rate). 2. To evaluate user comprehension of the IFU through survey parameters (customer demographics, ease of device usage, and comprehension of collection and shipping instructions). Potential users collected saliva samples at home using standard Oragene®●Dx device instructions and mailed them to a testing laboratory. At a CLIA certified laboratory, each sample was assessed for compliance to collection instructions and sample volume, and DNA concentration. Results met acceptance criteria, demonstrating that the Oragene®●Dx collection device can be used successfully in the direct-to-consumer setting.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K110786, DEN140044, DEN160026, K183530
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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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
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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)
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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.
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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.
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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 2C92, 2C93 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.
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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 was completed. This usability study evaluated user comprehension and compliance to the standard Oragene® -Dx device Instructions for Use (IFU). The objective of the study was to demonstrate that customers comprehend the instructions for use provided with the Oragene®·Dx device and can successfully collect saliva samples acceptable for use in over-the-counter (direct-to-consumer) setting.
Specifically,
- . To evaluate if study participants can correctly perform the sample collection through management of physical sample parameters, including the volume of sample, compliance of the sample with collection instructions, the concentration of extracted DNA, and test performance (call rate).
- To evaluate user comprehension of the IFU through survey parameters that include customer demographics, opinion on the ease of device usage, and user comprehension of the collection and shipping instructions.
Potential users enrolled in usability studies collected saliva samples at home using standard Oragene®●Dx devices instructions and mailed them to a testing laboratory as is typical in a direct-toconsumer 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 met the acceptance criteria for the study and demonstrated that the Oragene®●Dx collection device can be used successfully in the direct-to-consumer setting.
CONCLUSION
The submitted information in this premarket notification is complete and supports the safety and effectiveness of the Oragene®●Dx devices for prescription and over-the-counter (direct-to-consumer) use with FDA cleared and legally marketed molecular diagnostics applications.