(255 days)
No
The summary describes a genetic test using electrochemical detection and does not mention any AI or ML components. The performance studies focus on reproducibility and method comparison with sequencing, not on training or evaluating AI/ML models.
No
The device is an in vitro diagnostic test for genotyping related to warfarin sensitivity, aiding in patient identification but not directly providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "eSensor® Warfarin Sensitivity Saliva Test is an in vitro diagnostic" and the "eSensor® XT-8 instrument is an in vitro diagnostic device."
No
The device description explicitly includes hardware components such as the eSensor® Warfarin Sensitivity Saliva Test cartridge, reagents, and the eSensor® XT-8 System instrument.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The eSensor® Warfarin Sensitivity Saliva Test is an in vitro diagnostic..."
- "The eSensor® XT-8 instrument is an in vitro diagnostic device..."
This clearly identifies both the test kit and the associated instrument as in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
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 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.
The eSensor® XT-8 instrument is an in vitro diagnostic device intended for genotyping multiple mutations or polymorphisms in an amplified DNA sample utilizing electrochemical detection technology.
Product codes (comma separated list FDA assigned to the subject device)
ODW, ODV, NSU
Device Description
The kit consists of the eSensor® Warfarin Sensitivity Saliva Test cartridge, the eSensor® Warfarin Sensitivity Saliva Test amplification reagents (including PCR mix and DNA polymerase), the eSensor® Warfarin Sensitivity Saliva Test detection reagents (including exonuclease, probes and hybridization buffer ingredients) and the eSensor® XT-8 System. One eSensor® Warfarin Sensitivity Saliva Test Kit has sufficient materials for 24 tests.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The following studies were conducted to validate the performance of the ORAcollect-Dx device:
- Reproducibility
- Method Comparison
- Interfering Substances
Reproducibility:
Three samples (collected using three lots of ORAcollect-Dx format OCD-100) from each of ten donors, were processed by three different operators on multiple days. Each operator extracted DNA from each sample using the same Qiagen QIAamp DNA mini kit, followed by determination of DNA concentration and A260/A280 ratio for all samples. Three operators tested the extracted DNA samples on the eSensor Warfarin Saliva Sensitivity Test. Genotyping data was evaluated after first-pass results and all samples were concordant to bi-directional sequencing.
Key Results: All samples showed 100% agreement with bi-directional sequencing for all SNPs (CYP450 2C9 *2, CYP450 2C9 *3, VKORC1 -1639G>A). (N=60 for each SNP, combined operator results)
Multi-center reproducibility:
Thirty (30) donors collected multiple saliva samples each from 3 sites; 2 of the 3 sites were in a professional setting and had supervised collections compared to unsupervised collections at the third site. The 30 donors were selected to encompass a diverse genotype distribution for CYP2C9 and VKORC1 genotype distribution. After sample collection, one sample from each donor was transported at ambient temperatures to three (3) independent sites. Each site had one operator for a study total of 3 operators. Following sample extraction using the QIAamp DNA mini kit, all purified genomic DNA samples were tested for DNA concentration, yield and A260/A280 at the sites where they were extracted. All purified genomic DNA samples were transported to Site 1 for testing on the eSensor Warfarin Sensitivity Saliva Test where one extracted DNA aliquot from each sample from each site was tested on the Warfarin assay, excluding a single sample that did not meet assay input criteria.
Key Results: When data from all three sites are combined, only one (1) sample did not meet the eSensor Warfarin Sensitivity Saliva Test input requirements. After final pass there was 100% agreement (89/89) with bidirectional sequencing. Percentage agreement with Bi-directional Sequencing was 100% for all three sites (Site 1: 30 tested, 30 correct; Site 2: 30 tested, 30 correct; Site 3: 29 tested, 29 correct).
Method Comparison:
In a method comparison study, a total of 156 saliva samples were genotyped using the eSensor® Warfarin Sensitivity Saliva Test and DNA sequencing.
Key Results: The genotyping calls by the eSensor® Warfarin Sensitivity Saliva Test method were 99.4% concordant with genotypes determined by DNA sequencing for all polymorphisms, with a 98.1% first-pass call rate and 99.4% final pass call rate.
- CYP2C9 *2: %Agreement: 99.0% (wt/wt), 100.0% (wt/*2), 100.0% (*2/*2) (after retest)
- CYP2C9 *3: %Agreement: 100.0% (wt/wt), 95.0% (wt/*3), 100.0% (*3/*3) (after retest)
- VKORC1: %Agreement: 98.4% (G/G), 100.0% (G/A), 100.0% (A/A) (after retest)
Interfering Substances:
Interfering substances including salivary α-amylase, hemoglobin, immunoglobulin A (IgA) and total protein were spiked into saliva samples at the highest amounts found in literature. 14 donors provided four saliva samples each which were each spiked with one of the four interfering substances.
Key Results: There was 100% agreement between the eSensor® Warfarin Sensitivity Saliva Test results and bidirectional DNA sequencing for all test substances after re-test, demonstrating no effect of any interfering substances on genotyping. (N=14 for each substance).
Effect of Exogenous Interfering Substances:
Potentially interfering exogenous substances introduced into saliva samples through various activities (eating, drinking, chewing gum, using mouthwash, smoking and brushing teeth) were tested. Each activity group was composed of five to nine donors who each provided samples immediately after activity and 30 minutes post-activity.
Key Results: There was 100% agreement between the eSensor® Warfarin Sensitivity Saliva Test results and bidirectional DNA sequencing for all activities tested in first pass, demonstrating no effect of any interfering substances on genotyping.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement with bidirectional sequencing, percent agreement.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 862.3360 Drug metabolizing enzyme genotyping system.
(a)
Identification. A drug metabolizing enzyme genotyping system is a device intended for use in testing deoxyribonucleic acid (DNA) extracted from clinical samples to identify the presence or absence of human genotypic markers encoding a drug metabolizing enzyme. This device is used as an aid in determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme about which the system provides genotypic information.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping Test System.” See § 862.1(d) for the availability of this guidance document.
0
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2016
GENMARK DIAGNOSTICS, INCORPORATED ALAN MADERAZO VP, QUALITY, REGULATORY, & CLINICAL AFFAIRS 5964 LA PLACE COURT CARLSBAD CA 92008
Re: K152612
Trade/Device Name: eSensor Warfarin Sensitivity Saliva Test Regulation Number: 21 CFR §862.3360 Regulation Name: Drug Metabolism Enzyme Genotyping Test Regulatory Class: II Product Code: ODW, ODV, NSU Dated: April 21, 2016 Received: April 22, 2016
Dear Mr. Maderazo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152612
Device Name eSensor® Warfarin Sensitivity Saliva Test
Indications for Use (Describe)
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 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.
The eSensor® XT-8 instrument is an in vitro diagnostic device intended for genotyping multiple mutations or polymorphisms in an amplified DNA sample utilizing electrochemical detection technology.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
eSensor® Warfarin Sensitivity Saliva Test
Attached is a 510(k) summary as described in 21 CFR 807.92
Sponsor Information
| Submitted By: | |
|---|---|
| Name: | GenMark Diagnostics, Incorporated |
| Address: | 5964 La Place Court |
| Carlsbad, CA 92008 | |
| (760) 448-4300 |
| Company Contact: | |
|---|---|
| Contact: | Alan Maderazo, Ph.D., RAC |
| VP, Quality Assurance, Regulatory and Clinical Affairs | |
| Phone: | 760-448-4308 |
| Fax: | 760-683-6961 |
| Email: | al.maderazo@genmarkdx.com |
Date Prepared: May 23, 2016
General Information
Trade Name: eSensor® Warfarin Sensitivity Saliva Test
eSensor® Warfarin Sensitivity Saliva Test
| Device Description | Drug metabolizing enzyme genotyping test
Prothrombin time test, |
|--------------------|--------------------------------------------------------------------|
| Medical Specialty | Hematology |
| Product Code | ODW, ODV |
| Device Class | 2 |
| Regulation number | 862.3360, 864.7750 |
Instrument (XT-8)
| Device Description | Instrumentation for clinical multiplex test systems |
|---|---|
| Medical Specialty | Clinical Chemistry |
| Product Code | NSU |
| Device Class | 2 |
| Regulation number | 862.2570 |
4
Predicate device: eSensor® Warfarin Sensitivity Saliva Test, K110786
This premarket application is a labeling modification to a previously cleared device: addition of a new specimen collection kit.
Device Description
The kit consists of the eSensor® Warfarin Sensitivity Saliva Test cartridge, the eSensor® Warfarin Sensitivity Saliva Test amplification reagents (including PCR mix and DNA polymerase), the eSensor® Warfarin Sensitivity Saliva Test detection reagents (including exonuclease, probes and hybridization buffer ingredients) and the eSensor® XT-8 System. One eSensor® Warfarin Sensitivity Saliva Test Kit has sufficient materials for 24 tests.
The polymorphisms genotyped by the eSensor® Warfarin Sensitivity Saliva Test are shown in Table 1.
| Table 1. Polymorphisms in the eSensor® Warfarin Sensitivity
| Saliva Test Panel | |
|---|---|
| Polymorphism | Allele† |
| CYP450 2C9 430 C>T | *2 |
| CYP450 2C9 1075A>C | *3 |
| VKORC1 -1639G>A | GG, GA, or AA |
| † CYP450 2C9 allele designations as established by the Human | |
| Cytochrome P450 (CYP) Allele Nomenclature Committee | |
| (http://www.cypalleles.ki.se/cyp2c9.htm). The major alleles of | |
| these polymorphisms are designated as *1. |
5
Intended Use
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 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.
The eSensor® XT-8 instrument is an in vitro diagnostic device intended for genotyping multiple mutations or polymorphisms in an amplified DNA sample utilizing electrochemical detection technology.
6
Comparison to Predicate
This premarket application is a labeling modification to a previously cleared device: addition of a new specimen collection kit (the ORAcollect®·Dx Device manufactured by DNA Gentek). The data supporting the use of this specimen collection kit are provided in K152464.
| Similarities | ||
|---|---|---|
| Item | Proposed Device | Predicate Device (K110786) |
| Intended Use | 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) | Same | |
| Indications for Use | as an aid in the identification of patients at risk for increased warfarin sensitivity | Same |
| Device Components | Test cartridge, amplification reagents (including PCR mix and DNA polymerase), detection reagents (including exonuclease, probes and hybridization buffer ingredients) and the eSensor® XT-8 System. | Same |
7
Performance Data
The following studies were conducted to validate the performance of the ORAcollect-Dx device:
- Reproducibility .
- . Method Comparison
- Interfering Substances .
Summaries of the study results are provided. The formal study reports are provided in K152464.
Reproducibility
Reproducibility of the performance of the ORAcollect-Dx device was evaluated to establish multi-center (site-to-site), lot-to-lot, sample-to-sample, day-to-day extraction and operator-tooperator reproducibility.
Sample-to-Sample, Lot-to-Lot, Day-to-Day and Operator-to-Operator Reproducibility
Three samples (collected using three lots of ORAcollect-Dx format OCD-100) from each of ten donors, were processed by three different operators on multiple days. Each operator extracted DNA from each sample using the same Qiagen QIAamp DNA mini kit, followed by determination of DNA concentration and A260/A280 ratio for all samples. Three operators tested the extracted DNA samples on the eSensor Warfarin Saliva Sensitivity Test. Genotyping data was evaluated after first-pass results and all samples were concordant to bi-directional sequencing.
8
| | SNP | Samples
Tested | Correct
Calls | Incorrect
Calls | No-
Calls | %
Agreement |
|---------------|-------|-------------------|------------------|--------------------|--------------|----------------|
| Operator
1 | 2C92 | 20 | 20 | 0 | 0 | 100% |
| | 2C93 | 20 | 20 | 0 | 0 | 100% |
| | VKOR | 20 | 20 | 0 | 0 | 100% |
| Operator
2 | 2C92 | 20 | 20 | 0 | 0 | 100% |
| | 2C93 | 20 | 20 | 0 | 0 | 100% |
| | VKOR | 20 | 20 | 0 | 0 | 100% |
| Operator
3 | 2C92 | 20 | 20 | 0 | 0 | 100% |
| | 2C93 | 20 | 20 | 0 | 0 | 100% |
| | VKOR | 20 | 20 | 0 | 0 | 100% |
| Combined | 2C92 | 60 | 60 | 0 | 0 | 100% |
| | 2C93 | 60 | 60 | 0 | 0 | 100% |
| | VKOR | 60 | 60 | 0 | 0 | 100% |
Summary of Results Stratified by Operator
Summary of Results by Sample and Genotype
| Genotype by sequencing | | | Number of
Samples Tested
by eSensor | Number of
Correct Calls | %
Agreement | |
|------------------------|-------|-------|-------------------------------------------|----------------------------|----------------|------|
| Donor ID | 2C92 | 2C93 | VKOR | | | |
| REP01 | WT | WT | HET | 12 | 12 | 100% |
| REP02 | HET | WT | WT | 12 | 12 | 100% |
| REP03 | HET | WT | MUT | 12 | 12 | 100% |
| REP04 | HET | WT | WT | 12 | 12 | 100% |
| REP05 | HET | HET | HET | 12 | 12 | 100% |
| REP06 | WT | MUT | MUT | 12 | 12 | 100% |
| REP07 | MUT | WT | WT | 12 | 12 | 100% |
| REP08 | HET | HET | HET | 12 | 12 | 100% |
| REP09 | WT | WT | HET | 12 | 12 | 100% |
| REP10 | MUT | WT | WT | 12 | 12 | 100% |
| Total | | | | 120 | 120 | 100% |
Multi-center reproducibility
Thirty (30) donors collected multiple saliva samples each from 3 sites; 2 of the 3 sites were in a professional setting and had supervised collections compared to unsupervised collections at the third site. The 30 donors were selected to encompass a diverse genotype distribution for CYP2C9 and VKORC1 genotype distribution. After sample collection, one sample from each donor was transported at ambient temperatures to three (3) independent sites. Each site had one operator for a study total of 3 operators. Following sample extraction using the QIAamp DNA
9
mini kit, all purified genomic DNA samples were tested for DNA concentration, yield and A260/A280 at the sites where they were extracted. All purified genomic DNA samples were transported to Site 1 for testing on the eSensor Warfarin Sensitivity Saliva Test where one extracted DNA aliquot from each sample from each site was tested on the Warfarin assay, excluding a single sample that did not meet assay input criteria. When data from all three sites are combined, only one (1) sample did not meet the eSensor Warfarin Sensitivity Saliva Test input requirements. After final pass there was 100% agreement (89/89) with bidirectional sequencing.
Summary of Results by Site (Final Pass)
| eSensor Warfarin Sensitivity Saliva Test*** | |||||
|---|---|---|---|---|---|
| Site of sample | |||||
| extraction* | Number of | ||||
| Samples Tested** | Correct | ||||
| Calls | Incorrect | ||||
| Calls | No-calls | % Agreement with Bi- | |||
| directional Sequencing | |||||
| Site 1 | 30 | 30 | 0 | 0 | 100% |
| Site 2 | 30 | 30 | 0 | 0 | 100% |
| Site 3**** | 29 | 29 | 0 | 0 | 100% |
※ DNA extraction using QIAGEN QIAMP DNA Mini kit.
** Donor genotype representation: CYP2C9 (*1, *2, *3); VKOR
*** All eSensor Warfarin Sensitivity Saliva testing was conducted at Site 1 (by Operator 1). Only sample aliquots meeting the WST input criteria were tested.
**** One sample was excluded from WST testing
Method Comparison
In a method comparison study, a total of 156 saliva samples were genotyped using the eSensor® Warfarin Sensitivity Saliva Test and DNA sequencing. The genotyping calls by the eSensor® Warfarin Sensitivity Saliva Test method were 99.4% concordant with genotypes determined by DNA sequencing for all polymorphisms, with a 98.1% first-pass call rate and 99.4% final pass call rate. The following tables summarize the results of the method comparison study after retests.
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| eSensor® Warfarin Sensitivity Saliva Test Method Comparison After Retest | |||
|---|---|---|---|
| DNA Sequencing Result | 2C9 wt/wt | 2C9 wt/*2 | 2C9*2/*2 |
| Correct Calls | 104 | 46 | 5 |
| No-Calls* | 1 | 0 | 0 |
| Miscalls | 0 | 0 | 0 |
| %Agreement | 99.0% | 100.0% | 100.0% |
| 95% LCB | 95.6% | 93.7% | 54.9% |
| DNA Sequencing Result | 2C9 wt/wt | 2C9 wt/*3 | 2C9 *3/*3 |
| Correct Calls | 135 | 19 | 1 |
| No-Calls* | 0 | 1 | 0 |
| Miscalls | 0 | 0 | 0 |
| %Agreement | 100.0% | 95.0% | 100.0% |
| 95% LCB | 97.8% | 78.4% | 5.0% |
| DNA Sequencing Result | VKORC1 | ||
| G/G | VKORC1 | ||
| G/A | VKORC1 | ||
| A/A | |||
| Correct Calls | 63 | 71 | 21 |
| No-Calls* | 1 | 0 | 0 |
| Miscalls | 0 | 0 | 0 |
| %Agreement | 98.4% | 100.0% | 100.0% |
| 95% LCB | 92.8% | 95.9% | 86.7% |
| On First pass there were 2 miscalls due to operator error (sample mix-up) occurring during the first XT8 testing. |
- After Final pass, one no call remained unresolved, likely due to an operator error at the purification step of the protocol.
Interfering Substances
Interfering substances including salivary α-amylase, hemoglobin, immunoglobulin A (IgA) and total protein were spiked into saliva samples at the highest amounts found in literature. 14 donors provided four saliva samples each which were each spiked with one of the four interfering substances. There was 100% agreement between the eSensor® Warfarin Sensitivity Saliva Test results and bidirectional DNA sequencing for all test substances after re-test, demonstrating no effect of any interfering substances on genotyping.
| Substance | Samples
Tested | Correct
Calls | Incorrect
Calls | No-Calls | %
Agreement |
|---------------|-------------------|------------------|--------------------|----------|----------------|
| Amylase | 14 | 14 | 0 | 0 | 100% |
| Hemoglobin | 14 | 14 | 0 | 0 | 100% |
| IgA | 14 | 14 | 0 | 0 | 100% |
| Total Protein | 14 | 14 | 0 | 0 | 100% |
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Effect of Exogenous Interfering Substances:
Potentially interfering exogenous substances introduced into saliva samples through various activities (eating, drinking, chewing gum, using mouthwash, smoking and brushing teeth) were tested. Each activity group was composed of five to nine donors who each provided samples immediately after activity and 30 minutes post-activity. There was 100% agreement between the eSensor® Warfarin Sensitivity Saliva Test results and bidirectional DNA sequencing for all activities tested in first pass, demonstrating no effect of any interfering substances on genotyping.
| Activity | Time-point | Samples
Tested | Correct
Call | Incorrect
Call | No-call | % Agreement |
|----------------|------------|-------------------|-----------------|-------------------|---------|-------------|
| Eating | Immediate | 8 | 8 | 0 | 0 | 100% |
| | 30 minutes | 9 | 9 | 0 | 0 | 100% |
| Drinking | Immediate | 8 | 8 | 0 | 0 | 100% |
| | 30 minutes | 9 | 9 | 0 | 0 | 100% |
| Chewing Gum | Immediate | 7 | 7 | 0 | 0 | 100% |
| | 30 minutes | 7 | 7 | 0 | 0 | 100% |
| Smoking | Immediate | 5 | 5 | 0 | 0 | 100% |
| | 30 minutes | 5 | 5 | 0 | 0 | 100% |
| Mouthwash | Immediate | 5 | 5 | 0 | 0 | 100% |
| | 30 minutes | 5 | 5 | 0 | 0 | 100% |
| Brushing Teeth | Immediate | 9 | 9 | 0 | 0 | 100% |
| | 30 minutes | 9 | 9 | 0 | 0 | 100% |
Conclusion
The above test results support the safety and effectiveness of the eSensor® Warfarin Sensitivity Saliva Test on the eSensor® XT-8 System, and demonstrate substantial equivalence to the predicate device.