(263 days)
Oragene-Dx is intended for use in the non-invasive collection of saliva samples. DNA from the saliva sample is isolated, stabilized, and suitable for use in FDA cleared molecular diagnostic applications. Saliva may be collected by spitting directly into the Oragene-Dx container or may be transferred into the Oragene·Dx container using a sponge. Saliva samples collected using Oragene·Dx are stabilized and can be transported and/or stored long term at ambient conditions.
The Oragene·Dx family of products offers reliable collection, transportation and long-term room temperature storage of human DNA from saliva. Oragene Dx is a non-invasive alternative for collecting high quality and quantity DNA for use in molecular diagnostic applications. All formats consist of a collection tube, stabilizing liquid and optional sponges for assisted collection. After saliva is collected, the stabilizing liquid is mixed with the sample. Saliva can be delivered directly by spitting or using provided sponges to transfer saliva into the device.
Here's a breakdown of the acceptance criteria and study information for the Oragene·Dx device, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Oragene·Dx device are not explicitly stated as distinct pass/fail thresholds in the provided document. However, the performance characteristics and the successful outcome of the studies (e.g., 100% correct calls after re-testing in most cases) imply that these reported values met the internal and FDA requirements for substantial equivalence. The key performance metrics evaluated were:
- DNA Yield (µg): Quantity of DNA extracted.
- DNA Concentration (ng/µL): Concentration of DNA in the extracted sample.
- A260/A280 Ratio: Indicator of DNA purity (ratio of absorbance at 260 nm to 280 nm). A value around 1.7 to 2.0 typically indicates pure DNA.
- % Correct Calls on downstream molecular diagnostic application: The ability of the extracted DNA to produce accurate results in the eSensor® Warfarin Sensitivity Saliva Test.
- Stability: Ability to maintain DNA quality and quantity over time and under various storage/transport conditions.
- Tolerance to interfering substances: Ability to perform correctly despite the presence of common interfering substances.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|---|
| DNA Yield (µg) | Adequate for FDA cleared molecular diagnostic applications. | OGD-500: Mean 58.52 ± 47.02 µg; Median 48.44 µg; 95% samples ≥ 13.1 µg. OGD-575: Mean 13.50 ± 8.84 µg; Median 10.96 µg; 95% samples ≥ 3.8 µg.OXD-525: Mean 50.10 ± 42.38 µg; Median 33.35 µg; 95% samples ≥ 14.8 µg.OYD-500: Mean 56.05 ± 46.84 µg; Median 37.28 µg; 95% samples ≥ 13.0 µg. |
| DNA Concentration (ng/µL) | Adequate for FDA cleared molecular diagnostic applications. | OGD-500: Mean 68.11 ± 55.27 ng/µL; Median 55.27 ng/µL; 95% samples ≥ 16.0 ng/µL.OGD-575: Mean 41.12 ± 24.59 ng/µL; Median 33.20 ng/µL; 95% samples ≥ 11.2 ng/µL.OXD-525: Mean 88.89 ± 74.51 ng/µL; Median 60.22 ng/µL; 95% samples ≥ 27.6 ng/µL.OYD-500: Mean 65.38 ± 55.94 ng/µL; Median 42.11 ng/µL; 95% samples ≥ 14.8 ng/µL. |
| A260/A280 Ratio | Indicative of pure DNA (e.g., 1.7-2.0 or appropriate range). | All formats: Mean 1.7 ± 0.1; Median 1.7. OGD-500: 98% samples 1.5 - 2.0.Other formats: 98% samples 1.5 - 1.9. |
| % Correct Calls (eSensor Test) | 100% correct calls (post re-testing where applicable). | Initial Performance (Table 27): Ranged from 93.0% to 100% (with "no-calls").After Re-test (Table 27, Volume Tolerance, Reproducibility): Consistently 100% correct calls after re-testing or investigation, demonstrating suitability for the downstream application. |
| Sample Volume Tolerance | Maintenance of DNA quality and performance across volume range. | Maintained A260/A280 ratio and performance on eSensor test. 100% correct calls after re-testing for volumes from 0.58 mL to 3.64 mL. |
| Shelf-Life Stability | 24 months at room temperature (-20°C to 50°C transport). | Supported. Devices passed physical/chemical evaluations. |
| Post-Collection Sample Stability | 12 months at room temperature (-20°C to room temp), 3 months at 50°C | Supported for OGD-500, OGD-575, OYD-500. OXD-525 supported for 3 months at room temp. No significant change in microbial content. |
| Interfering Substances (eSensor Test) | 100% correct calls. | 100% correct calls on first-pass for all tested endogenous and exogenous substances. |
2. Sample Size Used for the Test Set and Data Provenance
- Performance Characteristics (Initial):
- OGD-500: 450 samples from 245 unique donors.
- OXD-525 & OYD-500: Subset of 45 donors.
- OGD-575: Subset of 43 donors.
- Sample Volume Tolerance Study: 240 samples using OGD-500.
- Reproducibility Study: 3 samples from each of 10 donors (total 30 samples collected, tested in triplicate by 4 operators, leading to 354-360 data points for yield/concentration, and 87-90 samples per SNP per operator for eSensor test).
- Post-Collection Sample Stability: 30 donors, each collecting four saliva samples for each of the 3 specified Oragene Dx formats (total 360 samples initially). A sub-population of 564 DNA samples across all time-points were tested on the eSensor® Warfarin Sensitivity Saliva Test.
- Interfering Substances Study: Samples from donors with known genotypes (exact number not specified beyond "samples").
Data Provenance: The document does not explicitly state the country of origin for the donors or samples. The study appears to be prospective in nature, as samples were "collected" for the purpose of the studies described (e.g., "samples were collected using OGD-500," "30 donors each self-collect four saliva samples").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The document does not specify the number of experts or their qualifications for establishing the ground truth of the genetic information (e.g., Warfarin Sensitivity SNPs) used with the eSensor® Warfarin Sensitivity Saliva Test. The "known genotypes" mentioned in the interfering substances study imply that the ground truth for the genetic markers was pre-established for the donors. The "Correct Calls" refer to the agreement with these known genotypes.
4. Adjudication Method for the Test Set
- The document does not describe an explicit adjudication method for discrepancies in the eSensor® Warfarin Sensitivity Saliva Test results. Instead, it mentions "re-testing" for initial no-calls. For instance, in the reproducibility study, "46 first-run no-calls were due to two runs... invalidated due to DNA Contamination Monitor (DCM) failures," and "The other first-pass no calls were low signal... positive control failure... and contradictory score." These suggest technical reasons for initial non-results, which were then resolved by re-testing. One incorrect call was "due to operator error resolved upon investigation," implying an internal review process rather than an independent expert adjudication of the initial assay result.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly done in the context of human readers improving with AI vs. without AI assistance. This device is a sample collection kit, not an AI diagnostic tool that assists human readers.
6. Standalone Performance Study (Algorithm Only)
- Yes, a standalone performance study was done in the sense that the extracted DNA from the Oragene·Dx device was tested directly on the eSensor® Warfarin Sensitivity Saliva Test, and the results (correct calls, incorrect calls, no-calls) were reported for the device's output. The performance of the Oragene·Dx device in preparing samples suitable for subsequent molecular diagnostic testing is evaluated objectively based on the accuracy of the eSensor test. This is considered "standalone" for the sample collection device's function as its "output" (DNA) is assessed by a subsequent analytical device without human interpretation of its own performance.
7. Type of Ground Truth Used
- The ground truth used for evaluating the performance of the extracted DNA on the eSensor® Warfarin Sensitivity Saliva Test was known genotypes for the relevant SNPs (2C92, 2C93, VKORC1). This implies that the genetic information of the donors was determined by a reliable, presumably validated, method prior to the study.
8. Sample Size for the Training Set
- The document describes performance evaluation studies but does not mention a training set as this is a sample collection device, not a machine learning algorithm that requires training. The studies described are validation studies for the device's performance characteristics.
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of a training set or machine learning algorithm, this question is not applicable. The "ground truth" (known genotypes) for the performance evaluation was established beforehand for the test samples through undisclosed methods.
{0}------------------------------------------------
DEC - 2 2011
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: | 30 November 2011 |
|---|---|
| Submitter: | DNA Genotek Inc.2 Beaverbrook Road, Ottawa,Ontario K2K 1L1 Canada |
| Contact: | Chantal Hemens-DavisVice President Operations, Quality & Regulatory Affairs(Official Correspondent)Tel: (613) 723-5757 Ext. 238, Fax: (613) 368-4628Email: chantal.hemens-davis@dnagenotek.com |
| Device ProprietaryNames | Oragene®·DxFormats: OGD-500, OGD-575, OXD-525, OYD-500 |
| Common names | Kit for collection of Human DNA, Saliva kit, Sample collection kit |
| Regulatory Classification | Regulation: 21CFR 862.1675Panel: Chemistry (75)Classification: Class IIProduct Code: OYJ DNA Specimen Collection, Saliva |
| Predicate Device | Vacutainer® Brand PPT™ Plasma Preparation Tube (K972075) |
DEVICE DESCRIPTION
The Oragene·Dx family of products offers reliable collection, transportation and long-term room temperature storage of human DNA from saliva. Oragene Dx is a non-invasive alternative for collecting high quality and quantity DNA for use in molecular diagnostic applications. All formats consist of a collection tube, stabilizing liquid and optional sponges for assisted collection. After saliva is collected, the stabilizing liquid is mixed with the sample. Saliva can be delivered directly by spitting or using provided sponges to transfer saliva into the device.
{1}------------------------------------------------
DNA Stabilization, Transportation and Storage
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. Oragene Dx samples are stable at room temperature for up to 12 months. Device and sample integrity are preserved during typical ambient transport and storage conditions.
Sample Processing and Testing
DNA extraction from Oragene-Dx can be performed using alcohol precipitation for the purpose of molecular diagnostic applications.
Intended Use
Oragene·Dx is intended for use in the non-invasive collection of saliva samples. DNA from the saliva sample is isolated, stabilized, and suitable for use in FDA cleared molecular diagnostic applications. Saliva may be collected by spitting directly into the Oragene-Dx container or may be transferred into the Oragene Dx container using a sponge. Saliva samples collected using Oragene-Dx are stabilized and can be transported and/or stored long term at ambient conditions.
Indications for Use
See "Intended Use", above.
{2}------------------------------------------------
COMPARISON TO MATERIAL AND TECHNOLOGICAL FEATURES OF THE PREDICATE DEVICE
The following table outlines the similarities and differences between Vacutainer® Brand PPT™ Plasma Preparation Tube (predicate) and Oragene-Dx Collection devices.
| Principle,Materials andTechnology | Vacutainer® Brand PPT™ PlasmaPreparation Tube | Oragene-Dx | Similar | Different |
|---|---|---|---|---|
| Description ofIntended Use | The Vacutainer® Brand PPT™Plasma Preparation Tube withEDTA anticoagulant and a gelbarrier material are evacuatedblood collection tubes whichprovide a means of collecting,processing and transporting bloodin a closed plastic tube. When theTube is used together withVacutainer® Brand Needles andHolders, it is a closed system forthe collection of venous blood withthe same indications identifiedhere.Blood collected in a tubecontaining EDTA anticoagulant andgel barrier material is usedprimarily to provide undilutedplasma for use in moleculardiagnostic test methods includingbut not limited to PCR (PolymeraseChain Reaction) and bDNA(branched DNA). The specimenmay also be used for other testingthat requires and undiluted plasmasample as determined by thelaboratory. | Oragene-Dx is intended for use inthe non-invasive collection of salivasamples. DNA from the salivasample is isolated, stabilized, andsuitable for use in FDA clearedmolecular diagnostic applications.Saliva may be collected by spittingdirectly into the Oragene-Dxcontainer or may be transferred intothe Oragene-Dx container using asponge. Saliva samples collectedusing Oragene-Dx are stabilized andcan be transported and/or storedlong term at ambient conditions. | X | |
| Analyte | Various (including DNA) | DNA | X | |
| Samplecollection | Biological samples collectedthrough venous puncture into asterile plastic evacuatedcollection tube | Non-invasive collection of biologicalsamples delivered into a non-sterileplastic collection tube | X | |
| Formats | Multiple | Multiple | X | |
| Tube material | Plastic | Plastic | X | |
| Sample source | Venous blood | Human saliva | X | |
| Additive | EDTA and gel barrier material | Nucleic acid stabilization solution | X | |
| Principle,Materials andTechnology | Vacutainer® Brand PPT™ PlasmaPreparation Tube | Oragene-Dx | Similar | Different |
| Transport andStability | Store unfilled tubes at 4-25°C.Limited excursion temperatures upto 40°C, for a cumulative time notto exceed 10 days, are acceptable. | Pre-collection Oragene-Dx kits can betransported at temperatures rangingfrom -20°C to 50°C | X | |
| Whole blood may be stored in theBD PPT™ Tube up to six (6) hoursprior to centrifugation. | Post-collection Oragene-Dx samplescan be transported at temperaturesranging from -20°C to 50°CPre-collection Oragene-Dx kits can bestored at room temperature for upto 24 monthsPost-collection Oragene-Dx samplescan be stored at room temperaturefor up to 12 months (OGD-500, OGD-575, OYD-500) and 3 months forOXD-525 | |||
| Suitabilityfor use withmoleculardiagnosticapplications | Used for testing plasma inmolecular diagnostics. | Stabilized DNA can be used inmolecular diagnostic testing. | X |
Table 25 – Similarities between Predicate and Oragene·Dx
{3}------------------------------------------------
Substantial Equivalence Discussion
The similarities in intended use, materials, technological characteristics show that Oragene Dx is substantially equivalent to Vacutainer® Brand PPT™ Plasma Preparation Tube. The differences tabulated above do not affect the safety and performance of Oragene Dx. Oragene Dx performance has been validated using GenMark Diagnostics' FDA cleared eSensor® Warfarin Sensitivity Saliva Test.
PERFORMANCE CHARACTERISTICS
Performance Characteristics of Oragene · Dx by Format
The DNA concentration and total sample DNA yield was determined by fluorescence and the A260/A280 ratio was determined by UV absorbance. These parameters were evaluated across all formats (OGD-500, OGD-575, OXD-525 and OYD-500). Data from a total of 450 samples from 245 unique donors is used in support of the performance characteristics for OGD-500. A subset of 45 donors is used in support of the performance characteristics for OXD-525 and OYD-500. A subset of 43 donors is used in support of the performance characteristics for OGD-575. All samples were extracted using an alcohol precipitation method. Downstream performance was demonstrated on the eSensor® Warfarin Sensitivity Saliva Test.
{4}------------------------------------------------
| OGD-500 | OGD-575 | OXD-525 | OYD-500 | ||
|---|---|---|---|---|---|
| Samples Tested | 450 | 43 | 45 | 45 | |
| Yield (µg) | Mean ± SD | 58.52 ± 47.02 | 13.50 ± 8.84 | 50.10 ± 42.38 | 56.05 ± 46.84 |
| Median | 48.44 | 10.96 | 33.35 | 37.28 | |
| 95% of samples | ≥ 13.1 | ≥ 3.8 | ≥ 14.8 | ≥ 13.0 | |
| Concentration (ng/µL) | Mean ± SD | 68.11 ± 55.27 | 41.12 ± 24.59 | 88.89 ± 74.51 | 65.38 ± 55.94 |
| Median | 55.27 | 33.20 | 60.22 | 42.11 | |
| 95% of samples | ≥ 16.0 | ≥ 11.2 | ≥ 27.6 | ≥ 14.8 | |
| A260/A280 ratio | Mean ± SD | 1.7 ± 0.1 | 1.7 ± 0.1 | 1.7 ± 0.1 | 1.7 ± 0.1 |
| Median | 1.7 | 1.7 | 1.7 | 1.7 | |
| 98% of samples | 1.5 - 2.0 | 1.5 - 1.9 | 1.5 – 1.9 | 1.5 – 1.9 |
Table 26 – Summary of DNA Yield Concentration and A260/A280 Ratio Results for Oragene-Dx Performance Characteristics
| Table 27 - Summary of eSensor® Warfarin Sensitivity Saliva Test Results for Oragene-Dx Format | |
|---|---|
| Comparison |
| Format | SNP | Samplestested | Correctcalls | Incorrectcalls | No-calls | % Correctcalls |
|---|---|---|---|---|---|---|
| OGD-500 | 2C9*2 | 45 | 45 | 0 | 0 | 100% |
| 2C9*3 | 45 | 45 | 0 | 0 | 100% | |
| VKORC1 | 45 | 45 | 0 | 0 | 100% | |
| OGD-575 | 2C9*2 | 43 | 40 | 0 | 3† | 93.0% |
| 2C9*3 | 43 | 40 | 0 | 3† | 93.0% | |
| VKORC1 | 43 | 40 | 0 | 3† | 93.0% | |
| OXD-525 | 2C9*2 | 45 | 45 | 0 | 0 | 100% |
| 2C9*3 | 45 | 45 | 0 | 0 | 100% | |
| VKORC1 | 45 | 45 | 0 | 0 | 100% | |
| OYD-500 | 2C9*2 | 45 | 45 | 0 | 0 | 100% |
| 2C9*3 | 45 | 45 | 0 | 0 | 100% | |
| VKORC 1 | 45 | 45 | 0 | 0 | 100% | |
| After re-test | ||||||
| OGD-575 | 2C9*2 | 43 | 43 | 0 | 0 | 100% |
| 2C9*3 | 43 | 43 | 0 | 0 | 100% | |
| VKORC1 | 43 | 43 | 0 | 0 | 100% |
† First-pass no-call results were due to eSensor® control failures.
:
.
.
{5}------------------------------------------------
SAMPLE VOLUME TOLERANCE
A total of 240 samples were collected using OGD-500 with modified "fill to" lines (the volume of stabilizing liquid was kept constant at 2 mL in each of the devices) in order to simulate both under and over spitting. Collected sample volumes ranged from as low as 0.58 mL of saliva to as much as 3.64 mL of saliva with a median collection volume of 2 mL.
As expected the DNA yield was dependent on collected volume and neither the A260/A280 ratio nor performance was affected by under or over spitting. All samples contained sufficient quality to be used on the eSensor® Warfarin Sensitivity Saliva Test. All 240 samples gave a correct call after re-testing.
Image /page/5/Figure/3 description: The image is a histogram showing the number of samples versus volume in mL. The x-axis represents volume in mL, ranging from 0.0 to 4.0, while the y-axis represents the number of samples, ranging from 0 to 30. The histogram shows the distribution of samples across different volume ranges, with the highest number of samples occurring between 1.0 and 2.5 mL.
Figure 1 -- Collected Saliva Volume in Sample Volume Tolerance Study
Table 28 - Summary of eSensor® Warfarin Sensitivity Saliva Test Results After Re-testing for Sample Volume Tolerance Study
| Range of collected salivavolume (mL) | Samplestested | Correctcalls | Incorrectcalls | No-calls | % Correctcalls |
|---|---|---|---|---|---|
| 0.58 – 3.64 | 240 | 240 | 0 | 0 | 100% |
" One first-pass no-call which was resolved upon re-testing.
{6}------------------------------------------------
REPRODUCIBILITY
The OGD-500 device reproducibility study was conducted at three sites (two external and one internal). Three samples (collected using three lots of OGD-500) from each of ten donors, covering all possible genotypes for three alleles for the eSensor® Warfarin Sensitivity Saliva Test, were tested in triplicate by four different operators at the three sites. Each operator extracted DNA from each sample using the same alcohol precipitation method, followed by determination of DNA concentration and A260/A280 ratio for all samples by an independent operator at one of the sites. Four operators at three sites tested the extracted DNA samples on the eSensor® Warfarin Sensitivity Saliva Test. The following table summarizes the yield, DNA concentration and A260/A280 ratio results obtained by four operators at the three sites.
| Operator 1 | Operator 2 | Operator 3 | Operator 4 | Combined | ||
|---|---|---|---|---|---|---|
| Samples tested | 87* | 87* | 90 | 90 | 354 | |
| Yield (µg) | Mean ± SD | 74.89 ±68.00 | 76.68 ±61.76 | 69.59 ±57.24 | 77.40 ±68.36 | 74.62 ±63.79 |
| Median | 57.31 | 66.32 | 60.95 | 57.62 | 60.39 | |
| 95% of samples | ≥ 23.23 | ≥ 26.56 | ≥ 18.13 | ≥ 26.02 | ≥ 23.47 | |
| Concentration(ng/µL) | Mean ± SD | 86.76 ±84.43 | 87.84 ±70.76 | 80.21 ±67.78 | 90.20 ±86.69 | 86.24 ±77.61 |
| Median | 63.83 | 74.43 | 68.82 | 66.20 | 68.58 | |
| 95% of samples | ≥ 25.87 | ≥ 29.58 | ≥ 20.42 | ≥ 28.98 | ≥ 26.74 | |
| A260/A280 | Mean ± SD | 1.9 ± 0.1 | 1.8 ± 0.1 | 1.9 ± 0.1 | 1.8 ± 0.1 | 1.9 ± 0.1 |
| Median | 1.9 | 1.8 | 1.9 | 1.8 | 1.9 | |
| 95% of samples | 1.6 - 2.3 | 1.6 - 2.1 | 1.7 - 2.0 | 1.5 - 2.0 | 1.6 - 2.2 |
Table 29 – Summary of Device Reproducibility DNA Concentration, Yield and A260/A280 Results
- One sample [3 aliquots] from a donor was excluded due to failure to meet incoming study screening criteria.
{7}------------------------------------------------
Table 30 – Summary of eSensor® Warfarin Sensitivity Saliva Test Results for Device Reproducibility Study Stratified by Site and Operator
・
:
| Site | Operator | SNP | Samplestested | Correctcalls | Incorrectcalls | No-calls* | % Correctcalls |
|---|---|---|---|---|---|---|---|
| Site 1 | Operator 1 | 2C9*2 | 87 | 86 | 0 | 1 | 98.9% |
| 2C9*3 | 87 | 86 | 0 | 1 | 98.9% | ||
| VKOR | 87 | 86 | 0 | 1 | 98.9% | ||
| Site 1 | Operator 2 | 2C9*2 | 87 | 86 | 0 | 1 | 98.9% |
| 2C9*3 | 87 | 86 | 0 | 1 | 98.9% | ||
| VKOR | 87 | 86 | 0 | 1 | 98.9% | ||
| Site 2 | Operator 3 | 2C9*2 | 90 | 87 | 1+ | 2 | 96.7% |
| 2C9*3 | 90 | 88 | 0 | 2 | 97.8% | ||
| VKOR | 90 | 87 | 1+ | 2 | 96.7% | ||
| Site 3 | Operator 4 | 2C9*2 | 90 | 43 | 0 | 47 | 47.8% |
| 2C9*3 | 90 | 43 | 0 | 47 | 47.8% | ||
| VKOR | 90 | 43 | 0 | 47 | 47.8% |
:
First-pass
After re-testing and investigation
| Operator | SNP | Samplestested | Correctcalls | Incorrect'calls | No-calls | % Correctcalls | |
|---|---|---|---|---|---|---|---|
| Site 1 | Operator 1 | 2C9*2 | 87 | 87 | 0 | 0 | 100% |
| 2C9*3 | 87 | 87 | 0 | 0 | 100% | ||
| VKOR | 87 | 87 | 0 | 0 | 100% | ||
| Operator 2 | 2C9*2 | 87 | 87 | 0 | 0 | 100% | |
| 2C9*3 | 87 | 87 | 0 | 0 | 100% | ||
| VKOR | 87 | 87 | 0 | 0 | 100% | ||
| Site 2 | Operator 3 | 2C9*2 | 90 | 90 | 0 | 0 | 100% |
| 2C9*3 | 90 | 90 | 0 | 0 | 100% | ||
| VKOR | 90 | 90 | 0 | 0 | 100% | ||
| Site 3 | Operator 4 | 2C9*2 | 90 | 90 | 0 | 0 | 100% |
| 2C9*3 | 90 | 90 | 0 | 0 | 100% | ||
| VKOR | 90 | 90 | 0 | 0 | 100% |
² Incorrect call due to operator error resolved upon investigation.
- 46 first-run no-calls were due to two runs (23 samples per run) invalidated due to DNA Contamination Monitor (DCM) failures. The other first-pass no calls were low signal for the 2C92 allele (three), positive control failure (one) and contractictory score at the 2C93 allele (one).
{8}------------------------------------------------
STABILITY
Shelf-life conditions were evaluated by storing unused devices (OGD-500, OXD-525 and OYD-500) at room temperature, 6°C ± 4°C or -20°C ± 5°C for up to 24 months. OGD-575 was not tested as the chemistry is identical to the OGD-500 format. Devices were exposed to multiple freeze/thaw cycles of -20°C ± 5°C/50°C ± 5°C. In a separate study, devices were sent by standard mail to donors for collection and the donors mailed their samples directly to the processing laboratories. At all study time points a subset of devices were evaluated for physical and chemical properties to ensure the product specifications remained within acceptable tolerances. Another subset of devices was used to collect saliva from which DNA was extracted and analyzed for vield and A260/A280 ratio.
The data supports shelf-life claims of room temperature storage for up to 24 months. Additionally, the devices may be transported by standard mail at temperatures ranging from -20°C ± 5°C.
Post-collection sample stability was evaluated by having 30 donors each self-collect four saliva samples for each Oragene Dx format (OGD-500, OXD-525 and OYD-500), for a study total of 360 samples. Samples were stored at room temperature, 6℃ ± 4℃ or -20℃ ± 5℃ for 12 months or at 50℃ ± 5℃ for 3 months. At all study time-points, DNA was extracted and analyzed for yield and A260/A280 ratio. Samples stored at room temperature were analyzed for microbial content using a real-time PCR-based assay. A sub-population of samples (564 DNA samples across all time-points) were tested on the eSensor® Warfarin Sensitivity Saliva Test.
The data supports post-collection storage of OGD-500, OGD-575 and OYD-500 at -20°C to room temperature for up to 12 months and at 50°C ± 5°C for 3 months. The data supports post-collection storage of OXD-525 at room temperature for up to 3 months. All formats stored at room temperature for 12 months exhibited no significant change in microbial content.
INTERFERING SUBSTANCES
Both endogenous (amylase, hemoglobin, lgA, total protein) and exogenous (eating, drinking, chewing gum, mouthwash, smoking) potentially interfering substances were added separately to samples from donors with known genotypes. Addition of tested substances had no effect as demonstrated through testing on the eSensor® Warfarin Sensitivity Saliva Test. All samples gave a correct call on first-pass.
CONCLUSION
The submitted information in this premarket notification is complete and supports the safety and effectiveness of the Oragene Dx family of collection devices.
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
10903 New Hampshire Avenue Silver Spring, MD 20993
DNA Genotek, Inc. c/o Chantal Hemens-Davis 2 Beaverbrook Road Ottawa. Ontario K2K 1L1 Canada
DEC - 2 2011
Re: K110701 Trade Name: Oragene•Dx OGD-500, Oragene•Dx OGD-575, Oragene•Dx OXD-525, Oragene.Dx OYD-500 Regulation Number: 21 CFR §862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Codes: OYJ Dated: October 24, 2011 Received: October 25, 2011
Dear Ms. Hemens-Davis:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{10}------------------------------------------------
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Virro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{11}------------------------------------------------
Indications for Use Form
510(k) Number (if known): K110701
Device Name: Oragene®•Dx Collection Devices: OGD-500; OGD-575; OXD-525; OYD-500
Indications for Use:
Oragene-Dx is intended for use in the non-invasive collection of saliva samples. DNA from the saliva sample is isolated, stabilized, and suitable for use in FDA cleared molecular diagnostic applications. Saliva may be collected by spitting directly into the Oragene-Dx container or may be transferred into the Oragene·Dx container using a sponge. Saliva samples collected using Oragene·Dx are stabilized and can be transported and/or stored long term at ambient conditions.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K. 11 070
§ 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.