ORAcollect®•Dx is intended for the collection of saliva samples for diagnostic testing of human DNA. Saliva samples may be collected by a healthcare professional or non-healthcare professional, such as a lay user. Saliva samples collected using ORAcollect®•Dx are stabilized and isolated for use in downstream diagnostic testing applications. Saliva samples collected using ORAcollect®•Dx can be transported and/or stored at ambient conditions.

Device Description

ORAcollect® Dx family of collection devices offers reliable collection, transportation and longterm ambient temperature storage of human DNA from saliva. ORAcollect® • Dx devices are a minimally invasive alternative for collecting high quality and quantity DNA for use with prescription and over-the-counter (direct-to-consumer) diagnostic testing applications.

ORAcollect® • Dx consists of a collection tube containing a stabilizing liquid and a double ended cap with an integrated sponge used to collect a saliva sample. Using provided instructions for use, saliva collection can take place in a laboratory setting, physician's office, at home, 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. 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.

ORAcollect-Dx device pre-collection shelf life is 24 months at room temperature (15°C to 25°C) from the date of manufacture. Post collection, ORAcollect·Dx samples are stable at room temperature for up to 60 days. ORAcollect-Dx device and sample integrity are preserved during typical ambient transport and storage conditions.

ORAcollect®●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 ORAcollect®●Dx for their specific indications for use. Using DNA obtained from an ORAcollect®•Dx sample, laboratory testing is performed on genotyping systems or platforms in a CLIA (Clinical Laboratory Improvement Amendments) certified laboratory.

AI/ML Overview

The provided text does not contain specific acceptance criteria with numerical thresholds or a detailed study description that directly proves the device meets those criteria in a standard "table of acceptance criteria and reported device performance" format.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Oragene®•Dx) and refers to various performance characteristics and previously evaluated studies (listed by k-number) that support the ORAcollect®•Dx device's performance.

However, based on the information provided, I can infer and summarize relevant details for each requested point:

1. A table of acceptance criteria and the reported device performance

Since explicit numerical acceptance criteria are not presented in the provided text, I will construct a table based on the discussed performance characteristics and the device's demonstrated suitability or equivalence. The "Reported Device Performance" will indicate that the device met the implied performance expectations by referring to the successful outcomes of the mentioned studies or equivalence claims.

Acceptance Criteria (Implied)	Reported Device Performance
Reproducibility/Precision: Reliable collection of DNA.	Previously evaluated (K152464) and further demonstrated with FDA-cleared test systems (eSensor® Warfarin Sensitivity Saliva Test (K152612) and Progenika Biopharma A1AT Genotyping Test (K192858, k21115)).
Pre-collection Shelf-life: Stability for extended storage.	Stored for 24 months at ambient room temperature conditions or exposed to typical transport conditions with no significant impact on performance (supported by studies in K152464).
Post-collection Sample Stability: Maintain sample integrity.	Stable for 60 days at room temperature and stable upon exposure to typical transport conditions (e.g., -20°C to 50°C) (supported by studies in K152464).
Sampling Variability (User Study): Robustness to user error.	Demonstrated robustness of the collection device samples collected using varied methods, incorrect methods, or incorrect sites, even by naïve users or when instructions were not followed properly (evaluated in K152464).
Dry Mouth Effect: Performance in dry mouth conditions.	Effect of dry mouth on collected samples evaluated (K152464). (Implied: device performs adequately).
Human Factors: User compliance and ease of use.	User compliance to instructions and impact on sample performance, as well as areas of difficulty, evaluated (K152464). (Implied: acceptable user experience and performance).
Interfering Substances (Endogenous/Exogenous): No adverse effects on performance.	No observable effect on performance due to potentially interfering endogenous or exogenous substances when tested with eSensor® Warfarin Sensitivity Saliva Test (K152612) and Progenika Biopharma A1AT Genotyping Test (K192858).
Matrix Comparison: Equivalence across device models.	ORAcollect® Dx (OCD-100.014) is considered physically and chemically equivalent to OCD-100. Insert in OCD-100A does not affect performance (study data in K152464).
Method Comparison: Agreement with gold standard.	Genotyping results on eSensor® Warfarin Sensitivity Saliva Test compared favorably to "gold standard" bidirectional sequencing (K152612 and K192858). (Implied: adequate agreement).
Over-the-Counter (Direct-to-Consumer) Use: User comprehension and successful sample collection.	Donors demonstrated comprehension of instructions and successfully collected saliva samples acceptable for DTC use, as evidenced by user comprehension survey and physical characteristics of participant samples (study for AlphaID™ At Home Genetic Health Risk Service using OCD-100.014).

2. Sample size used for the test set and the data provenance

The document references several previous 510(k) submissions (K152464, K152612, K192858, k21115, K221420) for the detailed studies. However, the exact sample sizes for the test sets in these underlying studies are not explicitly provided in this document.

For the "Over-the-Counter (Direct-to-Consumer) Use" study mentioned:

Sample Size: "potential users enrolled in usability studies" and "each study sample" refers to participant samples, but no specific number is given.
Data Provenance: The study involved users collecting samples "at home" and mailing them to a "CLIA certified laboratory" for assessment. This indicates prospective, real-world data collection in a consumer setting. No specific country of origin is mentioned, but DNA Genotek Inc. is based in Ottawa, Ontario, Canada, and the FDA review is for the U.S. market, suggesting a North American context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the text. The document refers to "genotyping systems or platforms in a CLIA certified laboratory" and comparison to "gold standard bidirectional sequencing" for method comparison, implying established laboratory procedures as the ground truth.

4. Adjudication method for the test set

This information is not provided in the text. Given the nature of the device (saliva collection kit for DNA), adjudication in the context of expert review of images or diagnoses is not directly applicable in the same way as for imaging AI. Instead, the "ground truth" would be established through laboratory analyses.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study is not applicable to this device. This device is a saliva collection kit, not an AI algorithm assisting human readers in diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical collection kit, not an algorithm. Its performance is evaluated on its ability to collect and stabilize DNA for subsequent laboratory testing, not on standalone interpretive capabilities.

7. The type of ground truth used

The ground truth for evaluating the ORAcollect®•Dx device's performance is primarily based on:

Laboratory-based analytical results: DNA concentration, purity, and successful genotyping after extraction from the collected saliva.
Comparison to "gold standard" methods: For instance, "gold standard bidirectional sequencing" for genotyping accuracy (as mentioned for method comparison studies in K152612 and K192858).
Compliance and physical assessment: For the over-the-counter use, ground truth involved assessing compliance to collection instructions, sample volume, and DNA concentration by a CLIA-certified laboratory.

8. The sample size for the training set

The document describes performance evaluation (test-set like activities) rather than the development of an algorithm requiring a "training set." Therefore, information on the "training set" sample size is not applicable/provided.

9. How the ground truth for the training set was established

As explained in point 8, the concept of a "training set" for this type of device is not applicable. The ground truth is established through standard laboratory and analytical methods as detailed in point 7 for performance evaluation.

Summary

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Image /page/0/Picture/0 description: The image shows 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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 27, 2022

DNA Genotek Inc. Jonathan Chan Senior Regulatory Affairs Specialist 3000 - 500 Palladium Drive Ottawa, Ontario, K2V 1C2 Canada

Re: K212745

Trade/Device Name: ORAcollect®•Dx Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: OYJ Dated: July 18, 2022 Received: July 21, 2022

Dear Jonathan Chan:

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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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 mediation-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.

Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212745

Device Name ORAcollect®•Dx

Indications for Use (Describe)

ORAcollect®»Dx is intended for the collection of salva samples for diagnostic testing of human DNA. Saliva samples may be collected by a healthcare professional or non-healthcare professional, such as a lay user. Saliva samples collected using ORAcollect®•Dx are stabilized and isolated for use in downstream diagnostic testing applications. Saliva samples collected using ORAcollect®•Dx can be transported and/or stored at ambient conditions.

Type of Use (Select one or both, as applicable)
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Depository Use (Part 21 CFR 601 Subpart D)
Same-Tissue Controls Use (21 CFR 601 Subpart G)	☒

__ 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:	27 October 2022
510(k) Number	K212745
Submitter:	DNA Genotek Inc.3000 – 500 Palladium Drive, Ottawa, Ontario K2V 1C2 Canada
Contact:	Jonathan Chan, Senior Regulatory Affairs SpecialistTel: (613) 723-5757 Ext. 2438Email: jonathan.chan@dnagenotek.com
Device Proprietary NameDevice models	ORAcollect®•DxOCD-100, OCD-100A, OCD-100.014
Common names	Kit for collection of human DNA, Saliva kit, Sample collection kit for over-the-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 (K192920)Regulation: 21CFR 862.1675 Blood specimen collection devicePanel: Chemistry (75)Classification: Class IIProduct Code: OYJ DNA Specimen Collection, Saliva

Intended use

ORAcollect®●Dx is intended for the collection of saliva samples for diagnostic testing of human DNA. Saliva samples may be collected by a healthcare professional or non-healthcare professional, such as a lay user. Saliva samples collected using ORAcollect®®Dx are stabilized and isolated for use in downstream diagnostic testing applications. Saliva samples collected using ORAcollect®●Dx can be transported and/or stored at ambient conditions.

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Indications for use

See Intended Use, above.

Special conditions for use statement

. ORAcollect®•Dx saliva samples can be self-collected.
ORAcollect®•Dx devices are intended for use in over-the-counter (direct-to-consumer) downstream diagnostic testing applications.
Test manufacturers must validate the use of ORAcollect®•Dx for their specific indications for use.
ORAcollect®●Dx is intended for collection and stabilization of human DNA from saliva, it is not intended for the collection and stabilization of RNA, protein, or hormones.
ORAcollect®●Dx has only been validated for use with germline testing.
For use in individuals 18 years of age and older.
ORAcollect® • Dx (OCD-100.014) device is intended for use (direct-to-consumer) use with AlphaID™ At Home Genetic Health Risk Service.

DEVICE DESCRIPTION

ORAcollect® Dx family of collection devices offers reliable collection, transportation and longterm ambient temperature storage of human DNA from saliva. ORAcollect® • Dx devices are a minimally invasive alternative for collecting high quality and quantity DNA for use with prescription and over-thecounter (direct-to-consumer) diagnostic testing applications.

To date, ORAcollect®●Dx collection device performance has been established with the following FDA cleared test systems:

eSensor® Warfarin Sensitivity Saliva Test (K152612)

The eSensor® Warfarin Sensitivity Saliva Test is an in vitro diagnostic 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 extracted from

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human saliva samples collected using the Oragene®·Dx and ORAcollect®·Dx devices, as an aid in the identification of patients at risk for increased warfarin sensitivity. For Prescription use only.

Progenika Biopharma A1AT Genotyping Test (K192858, K211115)

The Progenika A1AT genotyping kit is a quantitative, polymerase chain reaction (PCR) and hybridizationbased in vitro diagnostic test to be used with the Luminex 200 instrument (with xPONENT software) for the simultaneous detection and identification of 14 allelic variants and their associated alleles found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. The test intended for use with genomic DNA extracted from human whole blood samples collected as dry blood spot (DBS) or in K2-EDTA or from human saliva samples collected as buccal swabs using ORAcollect-Dx (OCD-100). The A1AT allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD). The kit is indicated for prescription use only.

AlphaID™ At Home Genetic Health Risk Service (K221420)

The AlphaID™ At Home Genetic Health Risk Service uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from human saliva collected from individuals ≥ 18 years old with the ORAcollect-Dx (OCD-100.014) for the purpose of reporting and interpreting genetic health risks. The service is intended to provide users with their genetic health risk linked to alpha-1antitrypsin deficiency (AATD). This information will help in their conversations with their healthcare professional.

Note: ORAcollect®·Dx (OCD-100.014) is a physically and chemically equivalent custom version of ORAcollect® Dx (OCD-100). ORAcollect® Dx (OCD-100.014) and is intended for use in the collection of saliva samples. Human DNA from the saliva sample is isolated, stabilized, and suitable for over-the-counter use with the AlphalD™ At Home Genetic Health Risk Service. Saliva samples collected using ORAcollect Dx (OCD-100.014) are stabilized and can be transported and/or stored long-term at ambient conditions.

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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 device –K192920)	ORAcollect®•Dx(proposed device – K212745)	Similar	Different
Intended Use	Oragene®•Dx is intended for usein the non-invasive collection ofsaliva samples for in vitrodiagnostic testing of humanDNA. Saliva may be collected byspitting directly into theOragene®•Dx container or maybe transferred into theOragene®•Dx container using asponge. Saliva samples may becollected by a healthcareprofessional or non-healthcareprofessional, such as a lay user.Saliva samples collected usingOragene®•Dx are stabilized andisolated for use in downstreamdiagnostic testing applications.Saliva samples collected usingOragene®•Dx can be transportedand/or stored long term atambientconditions	ORAcollect®•Dx is intendedfor the collection of salivasamples for diagnostictesting of human DNA.Saliva samples may becollected by a healthcareprofessional or non-healthcare professional,such as a lay user. Salivasamples collected usingORAcollect®•Dx arestabilized and isolated foruse in downstreamdiagnostic testingapplications. Saliva samplescollected usingORAcollect®•Dx can betransported and/or storedat ambient conditions.	X
Specialconditions foruse	Prescription and Over-the-counter use	Prescription and Over-the-counter use	X
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-510, OGD-575, OGD-600,OGD-610, OGD-675	Multiple: OCD-100, OCD-100A, OCD-100.014	X
Principle,Materials andTechnology	Oragene®•Dx(predicate device -K192920)	ORAcollect®•Dx(proposed device -K212745)	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®•Dxkits can be transported attemperatures ranging from-20°C to 50°C	Pre-collection ORAcollect®•Dxkits can be transported attemperatures ranging from-20°C to 50°C		X
	Post-collection Oragene®•Dxsamples can be transported attemperatures ranging from-20°C to 50°C	Post-collection ORAcollect®•Dxsamples can be transported attemperatures ranging from-20°C to 50°C
	Pre-collection Oragene®•Dxkits can be stored at roomtemperature for up to 30months	Pre-collection ORAcollect®•Dxkits can be stored at roomtemperature for up to 24 months
	Post-collection Oragene®•Dxsamples can be stored at roomtemperature for up to 12months	Post-collection ORAcollect®•Dxsamples can be stored at roomtemperature for up to 60 days
Performanceand suitabilityfor use withmoleculardiagnosticapplications	Performance of stabilized DNAused in molecular diagnostictesting has been established inK110701, K141410, K152556.Suitability of standardOragene®•Dx instructions foruse in a typical over-the-counter (direct-to- consumer)setting has been established(K192920)	Performance of stabilized DNAused in prescription and over-the-counter(direct-to-consumer) moleculardiagnostic testing has beenestablished with eSensor® WarfarinSensitivity Saliva Test(K152464, K152612). Progenika BiopharmaA1AT Genotyping Test(K192858, K211115) AlphaID™ At HomeGenetic Health RiskService (K221420)	X
The similarities in intended use, materials, technological characteristics show that ORAcollect® •Dx(K212745) are substantially equivalent to the primary predicate Oragene®•Dx devices (K192920). The
differences tabulated above do not affect the safety and performance of ORAcollect®•Dx devices.

Table 1. Comparison between Primary Predicate and Proposed devices

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PERFORMANCE CHARACTERISTICS

Reproducibility/Precision

The reproducibility of the ORAcollect®●Dx (device models: OCD-100A) collection device has been previously evaluated (see K152464). In addition, analytical precision of ORAcollect® Dx collection device has been further demonstrated with the following FDA cleared test systems eSensor® Warfarin Sensitivity Saliva Test (K152612) and Progenika Biopharma A1AT Genotyping Test (K192858, k21115).

Stability

Pre-collection shelf-life

Pre-collection shelf-life of ORAcollect® Dx devices has been previously evaluated and demonstrated (see K152464). ORAcollect®●Dx (device models: OCD-100) formats are FDA cleared and have of the same physical and chemical components including their instructions for use. Studies in K152464 supports that ORAcollect Dx devices can be stored for 24 months at ambient, room temperature conditions or exposed to typical transport conditions, with no significant impact on performance.

Post-collection sample stability

Post-collection sample stability of ORAcollect® Dx devices has been previously demonstrated (see K152464). ORAcollect®®Dx (device models: OCD-100) formats are FDA cleared and have of the same physical and chemical components including their instructions for use. Studies in K152464 supports that ORAcollect Dx sample stability of 60 days at room temperature and stability upon exposure to conditions expected during typical transport (i.e. transient exposure to temperatures between -20°C and 50°C.

Detection Limit

User Study

The effects of sampling variability due to user collection error, incorrect collection methods and collection from an incorrect site were previously evaluated in K152464. Study data demonstrated the robustness of the ORAcollect Dx collection device samples collected using the varied collected methods, incorrect collection methods or incorrect collection site even in the hands of naive users and/or when instructions for use are not followed properly.

Dry Mouth Study

The effect of dry mouth on the samples collected using the ORAcollect·Dx device was evaluated in K152464.

Human Factors

User compliance to ORAcollect® Dx collection instructions and its impact on sample performance, as well as to identify areas of difficulty in the collection procedure was evaluated in K152464.

Limit of Detection

For limit of detection on Progenika Biopharma A1AT Genotyping Test, see k21115.

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Interfering Substances

Endogenous Substances

The effect of potentially interfering endogenous substances on performance of saliva samples collected with the ORAcollect® Dx device has been successfully demonstrated with the following FDA cleared test systems eSensor® Warfarin Sensitivity Saliva Test (K152612) and Progenika Biopharma A1AT Genotyping Test (K192858). 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 ORAcollect®.Dx devices have been demonstrated with the following FDA cleared test systems eSensor® Warfarin Sensitivity Saliva Test (K152612) and Progenika Biopharma A1AT Genotyping Test (K192858). There was no observable effect to performance of any of the potentially interfering exogenous substances.

Comparison Studies

Matrix Comparison

ORAcollect® Dx is available in equivalent and identical formats OCD-100 and OCD-100A. The OCD-100A format includes a molded plastic insert inside the collection tube. The insert is intended to facilitate or enable a more efficient physical handling of the sample in the laboratory but has no impact on sample collection. Study data in K152464 indicates that the insert present in the OCD-100A format does not affect the performance of the device. ORAcollect® Dx (OCD-100.014) is a physically and chemically equivalent custom version of ORAcollect® Dx OCD-100.014 and is intended for use in the collection of saliva samples. Human DNA from the saliva sample is isolated, stabilized, and suitable for over-the-counter use with the AlphalD™ At Home Genetic Health Risk Service. Saliva samples collected using ORAcollect-Dx (OCD-100.014) are stabilized and can be transported and/or stored long-term at ambient conditions.

Method Comparison

Method comparison studies have been previously evaluated in K152612 and K192858. Genotyping results on the eSensor Warfarin Sensitivity Saliva Test were compared to results from the 'gold standard' bidirectional sequencing in order to assess performance.

Over-the-Counter (Direct-to-Consumer) Use

Performance of saliva samples collected with ORAcollect® Dx (device model OCD-100.014) when used in an over-the-counter (direct-to-consumer) setting. The objective of the study was to demonstrate that donors comprehend the instructions for use provided with the ORAcollect®·Dx device and can successfully collect saliva samples acceptable for use in an over-the-counter (direct-to-consumer) setting. ORAcollect•Dx collection device was provided as part of the AlphalD™ Saliva Collection Kit which is intended to be used with the AlphalD™ At Home Genetic Health Risk Service.

Specifically, potential users enrolled in usability studies collected saliva samples at home using standard ORAcollect®●Dx devices instructions and mailed them to a testing laboratory as is typical in

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a direct-to- consumer 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 demonstrated that the ORAcollect® Dx collection device can be used successfully in the direct-toconsumer setting.

CONCLUSION

The results from the studies submitted in this premarket notification are complete and demonstrate that the ORAcollect®●Dx device is substantially equivalent to the predicate device. The submitted information supports the use of the ORAcollect®●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.