(423 days)
No
The summary describes a saliva collection device and its performance characteristics, with no mention of AI or ML in its function or analysis.
No
This device is intended for the collection and stabilization of saliva samples for diagnostic testing of human DNA and is not designed to treat a medical condition.
No
This device is a saliva collection kit intended for the collection, stabilization, and storage of human DNA for downstream diagnostic testing, not the diagnostic testing itself.
No
The device description clearly states it consists of a collection tube, stabilizing liquid, and a double-ended cap with an integrated sponge, which are physical hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the collection of saliva samples for diagnostic testing of human DNA." This directly aligns with the definition of an IVD, which is a device intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease.
- Downstream Diagnostic Testing: The description repeatedly mentions that the collected and stabilized saliva samples are for "downstream diagnostic testing applications," "prescription and over-the-counter (direct-to-consumer) diagnostic testing applications," and "laboratory testing is performed on genotyping systems or platforms in a CLIA (Clinical Laboratory Improvement Amendments) certified laboratory." This confirms that the device is a component used in a diagnostic process.
- Performance Studies: The "Summary of Performance Studies" details various studies related to the device's performance in the context of diagnostic testing, such as reproducibility, stability, user studies, and interfering substances, often referencing FDA cleared test systems. This further supports its role in a diagnostic workflow.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K192920; Oragene®•Dx) indicates that this device is being compared to a previously cleared device, which is a common process for IVDs seeking regulatory clearance.
While the device itself is a collection device and not the diagnostic test itself, it is specifically designed and intended to be used as part of a diagnostic process by providing the necessary sample. Therefore, it falls under the category of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OYJ
Device Description
ORAcollect® Dx family of collection devices offers reliable collection, transportation and long-term 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Saliva (human DNA)
Indicated Patient Age Range
18 years of age and older.
Intended User / Care Setting
Healthcare professional or non-healthcare professional, such as a lay user. Can be used in a laboratory setting, physician's office, at home, or in the field.
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 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.
Stability (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: For limit of detection on Progenika Biopharma A1AT Genotyping Test, see k21115.
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.
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.
Interfering 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.
Comparison Studies (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 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-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.
Oragene®•Dx (K192920)
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.
K152612, K192858, K211115, K221420, K152464
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.
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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
1
- 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
2
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) |
|---|
| ------------------------------------------------- |
| 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 Specialist |
| Tel: (613) 723-5757 Ext. 2438 | |
| Email: jonathan.chan@dnagenotek.com | |
| Device Proprietary Name | |
| Device models | ORAcollect®•Dx |
| OCD-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 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 (K192920) |
| Regulation: 21CFR 862.1675 Blood specimen collection device | |
| Panel: Chemistry (75) | |
| Classification: Class II | |
| Product 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.
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.
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
5
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 and
Technology | Oragene®•Dx
(predicate device –
K192920) | ORAcollect®•Dx
(proposed device – K212745) | Similar | Different |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------|
| 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 | 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. | X | |
| Special
conditions for
use | Prescription and Over-the-
counter use | Prescription and Over-the-
counter use | X | |
| 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-
510, OGD-575, OGD-600,
OGD-610, OGD-675 | Multiple: OCD-100, OCD-
100A, OCD-100.014 | X | |
| Principle,
Materials and
Technology | 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 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 | Pre-collection ORAcollect®•Dx
kits can be transported at
temperatures ranging from
-20°C to 50°C | | X |
| | Post-collection Oragene®•Dx
samples can be transported at
temperatures ranging from
-20°C to 50°C | Post-collection ORAcollect®•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 ORAcollect®•Dx
kits can be stored at room
temperature for up to 24 months | | |
| | Post-collection Oragene®•Dx
samples can be stored at room
temperature for up to 12
months | Post-collection ORAcollect®•Dx
samples can be stored at room
temperature for up to 60 days | | |
| Performance
and suitability
for use with
molecular
diagnostic
applications | 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) | Performance of stabilized DNA
used in prescription and over-
the-counter(direct-to-
consumer) molecular
diagnostic testing has been
established with eSensor® Warfarin
Sensitivity Saliva Test
(K152464, K152612). Progenika Biopharma
A1AT Genotyping Test
(K192858, K211115) AlphaID™ At Home
Genetic Health Risk
Service (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.