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 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.

AI/ML Overview

The document describes the Oragene®•Dx saliva collection device and its performance characteristics to support its intended use for in vitro diagnostic testing of human DNA.

Here's the breakdown of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Oragene®•Dx device are largely demonstrated by referencing prior 510(k) clearances (K110701, K141410, K152556) and its compatibility with already FDA-cleared test systems. The performance characteristics focus on the stability and suitability of the collected DNA for downstream diagnostic applications.

Acceptance Criteria Category	Reported Device Performance
Reproducibility/Precision	Demonstrated through previous evaluations (K110701, K152556) and further confirmed with FDA cleared test systems: eSensor® Warfarin Sensitivity Saliva Test (K110786), 23andMe PGS (DEN140044, DEN160026), and Akonni TruDiagnosis® System (K183530).
Pre-collection Shelf-life	Supported by studies in K110701 and K152556, claiming: - 30 months at room temperature - 12 months at -20±5°C and 6±4°C (for device models OGD-500, OGD-510, OGD-575, OGD-600, OGD-610, OGD-675, which have the same physical and chemical components as previously cleared devices).
Post-collection Sample Stability	Supported by studies in K110701 and K152556 (specifically for OGD-500, and inferred for the proposed device due to identical physical/chemical components), claiming: - 12 months at room temperature, -20±5°C or 6±4°C - 3 months at 50±5°C Studies evaluated DNA yield, DNA concentration, A260/A280 ratio, and microbial content.
Sample Volume Tolerance	Demonstrated by previous studies (K110701) where underfilling (by 25% or 50% of target) or overfilling (by 50% of target) did not impact downstream performance, despite affecting DNA yield. Collected samples ranged from 0.58 mL to 3.64 mL of saliva. Further confirmed with FDA cleared test systems: eSensor® Warfarin Sensitivity Saliva Test (K110786), 23andMe PGS (DEN140044, DEN160026), and Akonni TruDiagnosis® System (K183530).
Interfering Substances (Endogenous)	Successfully demonstrated with FDA cleared test systems: eSensor® Warfarin Sensitivity Saliva Test (K110786), 23andMe PGS (DEN140044, DEN160026), and Akonni TruDiagnosis® System (K183530). No observable effect on performance.
Interfering Substances (Exogenous)	Successfully demonstrated with FDA cleared test systems: eSensor® Warfarin Sensitivity Saliva Test (K110786), 23andMe PGS (DEN140044, DEN160026), and Akonni TruDiagnosis® System (K183530). No observable effect on performance.
Over-the-Counter (Direct-to-Consumer) Use	Previously evaluated with 23andMe PGS (K141410, DEN140044) using OGD-500.001. A user comprehension study using standard Oragene®•Dx devices (K192920) in a simulated over-the-counter setting was completed. This usability study evaluated user comprehension and compliance with Instructions for Use (IFU), specifically: - Correct sample collection (physical parameters: volume, compliance, DNA concentration, call rate). - User comprehension of IFU (through demographics, ease of use, collection, and shipping instructions survey). The study results met acceptance criteria, demonstrating successful use in a direct-to-consumer setting.

2. Sample Size Used for the Test Set and the Data Provenance

Test Set Sample Size: The document does not explicitly state a specific numerical sample size for the user comprehension study conducted for the K192920 submission. It mentions "Potential users enrolled in usability studies." For other performance aspects (Reproducibility, Stability, Volume Tolerance, Interfering Substances), the document largely references previous 510(k) clearances and compatibility with existing FDA-cleared test systems, implying the sample sizes from those original studies were deemed sufficient.
Data Provenance: The document does not specify the country of origin for the data for any of the studies mentioned. The submitter is DNA Genotek Inc., located in Ottawa, Ontario, Canada.
Retrospective/Prospective: The user comprehension study for over-the-counter use appears to be prospective, as it involved "Potential users enrolled in usability studies collected saliva samples at home." The referenced studies for stability and other analytical performance characteristics were likely prospective as well, as they involved specific testing protocols to establish performance claims.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of clinical adjudication.
For the user comprehension study, the "ground truth" was established by objective measures such as successful collection of saliva, compliance with instructions, DNA concentration, and PCR call rate, as well as subjective user comprehension surveys. This process does not typically involve expert consensus on the "truth" of a clinical condition.
The overall "truth" for the device's function as a DNA collection device is its ability to yield high-quality DNA suitable for downstream diagnostic testing, as demonstrated by compatibility with FDA-cleared molecular diagnostic platforms.

4. Adjudication Method for the Test Set

Not applicable in the context of this device's performance claims. The studies focus on analytical performance (DNA yield, stability, compatibility) and user comprehension/compliance, rather than diagnostic accuracy requiring adjudication of clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This device is a saliva collection kit, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical collection kit, not an algorithm. Its performance is inherent to the physical and chemical properties of the kit and the stabilization solution, as well as user compliance with instructions.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the performance of the Oragene®•Dx device is primarily based on analytical performance metrics (DNA yield, DNA concentration, purity ratios (A260/A280), microbial content, PCR call rates) and functional compatibility with established FDA-cleared molecular diagnostic test systems.
For the Over-the-Counter use, the "ground truth" includes user compliance with instructions and successful sample collection based on objective parameters (volume, DNA quality) and user comprehension through surveys.

8. The Sample Size for the Training Set

Not applicable. This device is a physical collection kit, not a machine learning model that requires a training set. The performance is based on established chemical and physical principles and validated through testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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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

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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 ManagerTel: (613) 723-5757 Ext. 2245, Fax: (613) 368-4628Email: austin.udocor@dnagenotek.com
Device Proprietary NameDevice models	Oragene®.DxOGD-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 overthe-counter (direct-to-consumer) genetic testing use
Proposed DeviceRegulatory Classification	Regulation: 21CFR 862.1675 Blood specimen collection devicePanel: Chemistry (75)Classification: Class IIProduct Code: OYJ DNA Specimen Collection, Saliva
Predicate Device	Oragene®.Dx (K110701)Regulation: 21CFR 862.1675 Blood specimen collection devicePanel: Chemistry (75)Classification: Class IIProduct Code: OYJ DNA Specimen Collection, Saliva
Additional PredicateDevices	Oragene®.Dx (K141410, K152556)Regulation: 21CFR 862.1675 Blood specimen collection devicePanel: Chemistry (75)Classification: Class IIProduct 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

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 andTechnology	Oragene®•Dx(predicate - K110701)	Oragene®•Dx(proposed devices –K192920)	Similar	Different
Intended Use	Oragene®•Dx is intended for usein the non-invasive collection ofsaliva samples. DNA from thesaliva sample is isolated,stabilized, and suitable for use inFDA cleared moleculardiagnostic applications. Salivamay be collected by spittingdirectly into the Oragene®•Dxcontainer or may be transferredinto the Oragene®•Dx containerusing a sponge. Saliva samplescollected using Oragene®•Dx arestabilized and can betransported and/or stored longterm at ambient conditions	Oragene®•Dx is intended foruse in the non-invasivecollection of saliva samplesfor in vitro diagnostic testingof human DNA. Saliva maybe collected by spittingdirectly into theOragene®•Dx container ormay be transferred into theOragene®•Dx containerusing a sponge. Salivasamples may be collected bya healthcare professional ornon-healthcare professional,such as a lay user. Salivasamples collected usingOragene®•Dx are stabilizedand isolated for use indownstream diagnostictesting applications. Salivasamples collected usingOragene®•Dx can betransported and/or storedlong term at ambientconditions		×
Specialconditions foruse	Prescription use only	Prescription and Over-the-counter use		×
Analyte	DNA	DNA	X
Samplecollection	Non-invasive collection ofbiological samples delivered intoa non-sterile plastic collectiontube	Non-invasive collection ofbiological samples deliveredinto a non-sterile plasticcollection 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 andTechnology	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 stabilizationsolution	Nucleic acid stabilizationsolution	X
Transport andStability	Pre-collection Oragene®•Dx kitscan be transported attemperatures ranging from20°C to 50°CPost-collection Oragene®•Dxsamples can be transported attemperatures ranging from20°C to 50°CPre-collection Oragene®•Dx kitscan be stored at roomtemperature for up to 30 months	Pre-collection Oragene®•Dxkits can be transported attemperatures ranging from-20°C to 50°CPost-collectionOragene®•Dx samples canbe transported attemperatures ranging from-20°C to 50°C	X
	Post-collection Oragene®•Dxsamples can be stored at roomtemperature for up to 12 months(OGD-500, OGD-575, OYD-500)and 3 months for OXD-525	Pre-collection Oragene®•Dxkits can be stored at roomtemperature for up to 30monthsPost-collectionOragene®•Dx samples canbe stored at roomtemperature for up to 12months
Performanceand suitabilityfor use withmoleculardiagnosticapplications	Stabilized DNA can be used inmolecular diagnostic testing;e.g.,• Performance has beenestablished with theeSensor® WarfarinSensitivity Saliva Test.	Performance of stabilizedDNA used in moleculardiagnostic testing has beenestablished in K110701,K141410, K152556Suitability of standardOragene®•Dx instructionsfor use in a typical over-the-counter (direct-to-consumer) setting has beenestablished (K192920)	X
Principle,Materials andTechnology	Oragene®•Dx(additional predicate:K141410, K152556)	Oragene®•Dx(proposed devices - K192920)	Similar	Different
Intended Uses	Prescription (K152556):Oragene®•Dx is intended foruse in the non-invasivecollection of saliva samples.Human DNA from the salivasample is isolated, stabilized,and suitable for use in FDAcleared molecular diagnosticapplications. Saliva may becollected by spitting directlyinto the Oragene®•Dxcontainer or may betransferred into theOragene®•Dx container usinga sponge. Saliva samplescollected using Oragene®•Dxare stabilized and can betransported and/or storedlong term at ambientconditionsOver-the-counter (K141410):Oragene®•Dx OGD-500.001 isintended for use in the non-invasive collection of salivasamples. DNA from the salivasample is isolated, stabilized,and suitable for over-the-counter use with FDA cleared,approved, or legally marketedexempt DNA carrier screeninggenotyping tests. Salivasamples collected usingOragene•Dx OGD-500.001 arestabilized and can betransported and/or storedlong term at ambientconditions.	Oragene®•Dx is intended foruse in the non-invasivecollection of saliva samples forin vitro diagnostic testing ofhuman DNA. Saliva may becollected by spitting directlyinto the Oragene®•Dxcontainer or may betransferred into theOragene®•Dx container usinga sponge. Saliva samples maybe collected by a healthcareprofessional or non-healthcareprofessional, such as a layuser. Saliva samples collectedusing Oragene®•Dx arestabilized and isolated for usein downstream diagnostictesting applications. Salivasamples collected usingOragene®•Dx can betransported and/or storedlong term at ambientconditions	X
Principle,	Oragene®•Dx	Oragene®·Dx	Similar	Different
Materials andTechnology	(additional predicate:K141410, K152556)	(proposed devices - K192920)
Specialconditions foruse	Over-the-counter andprescription use	Prescription or Over-the-counter use	×
Analyte	DNA	DNA	×
Samplecollection	Non-invasive collection ofbiological samples deliveredinto a non-sterile plasticcollection tube	Non-invasive collection ofbiological samples deliveredinto a non-sterile plasticcollection 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 stabilizationsolution	Nucleic acid stabilizationsolution	×
Transport andStability	Pre-collection Oragene®•Dxkits can be transported attemperatures ranging from-20°C to 50°CPost-collection Oragene®•Dx	Pre-collection Oragene®•Dxkits can be transported attemperatures ranging from-20°C to 50°C	×
	samples can be transported attemperatures ranging from-20°C to 50°CPre-collection Oragene®•Dx	Post-collection Oragene®•Dxsamples can be transported attemperatures ranging from-20°C to 50°C
	kits can be stored at roomtemperature for up to 30monthsPost-collection Oragene®•Dxsamples can be stored at room	Pre-collection Oragene®•Dxkits can be stored at roomtemperature for up to 30months
	temperature for up to 12months (OGD-500, OGD-575,OYD-500) and 3 months forOXD-525	Post-collection Oragene®•Dxsamples can be stored at roomtemperature for up to 12months
Principle,Materials andTechnology	Oragene®•Dx(additional predicate:K141410, K152556)	Oragene®•Dx(proposed devices - K192920)	Similar	Different
Performanceand suitabilityfor use withmoleculardiagnosticapplications	Stabilized DNA can be used inmolecular diagnostic testing;e.g.,Performance has beenestablished with theeSensor® WarfarinSensitivity Saliva Test. Performance has beenestablished with the23andMe PersonalGenome Service	Performance of stabilized DNAused in molecular diagnostictesting has been established inK110701, K141410, K152556Suitability of standardOragene®•Dx instructions foruse in a typical over-the-counter (direct-to-consumer)setting has been established(K192920)	X

Table 1. Comparison between Primary Predicate and Proposed devices

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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.

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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

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DNA GENOTEK

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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 ●

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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.

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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.

Regulation Number and Section

§ 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.