(263 days)
Not Found
No
The summary describes a device for collecting and stabilizing saliva samples for DNA analysis, with no mention of AI or ML in its function or analysis.
No
The device is described as a collection kit for saliva samples to extract and stabilize DNA for molecular diagnostic applications, not for treating a disease or condition.
No
This device is designed for the collection and stabilization of saliva samples for DNA, which can then be used in FDA-cleared molecular diagnostic applications. It does not perform the diagnostic analysis itself; rather, it prepares the sample for such analysis.
No
The device description explicitly states that the product consists of a collection tube, stabilizing liquid, and optional sponges, which are all physical hardware components.
Based on the provided information, the Oragene-Dx device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the collected saliva samples are "suitable for use in FDA cleared molecular diagnostic applications." This directly links the device to diagnostic testing performed in vitro (outside the body).
- Device Description: The description reinforces this by stating it's for collecting DNA "for use in molecular diagnostic applications."
- Performance Studies: The performance studies demonstrate the suitability of the collected DNA for use with a specific FDA-cleared molecular diagnostic test, the "eSensor® Warfarin Sensitivity Saliva Test." The key metrics evaluated are related to the quality and performance of the DNA in this diagnostic context (e.g., correct calls on the diagnostic test).
- Predicate Device: While the predicate device listed (Vacutainer® Brand PPT™ Plasma Preparation Tube) is a blood collection tube, it is also a device used for preparing samples for in vitro diagnostic testing. This further supports the classification of Oragene-Dx as a device intended for use in the IVD workflow.
The Oragene-Dx device itself is not performing the diagnostic test, but it is a critical component in the process of collecting and preparing a sample for an in vitro diagnostic test. This makes it an IVD device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OYJ
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.
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.
DNA extraction from Oragene-Dx can be performed using alcohol precipitation for the purpose of molecular diagnostic applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Saliva samples
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)
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).
- OGD-500: Data from a total of 450 samples from 245 unique donors.
- OXD-525 and OYD-500: A subset of 45 donors.
- OGD-575: A subset of 43 donors.
All samples were extracted using an alcohol precipitation method. Downstream performance was demonstrated on the eSensor® Warfarin Sensitivity Saliva Test.
Sample volume tolerance study:
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.
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.
Reproducibility study:
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.
Stability study:
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 for 12 months exhibited no significant change in microbial content. 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.
Interfering substances study:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
-
Performance Characteristics of Oragene·Dx by Format:
- Yield (µg):
- OGD-500: Mean ± SD 58.52 ± 47.02, Median 48.44, 95% of samples ≥ 13.1
- OGD-575: Mean ± SD 13.50 ± 8.84, Median 10.96, 95% of samples ≥ 3.8
- OXD-525: Mean ± SD 50.10 ± 42.38, Median 33.35, 95% of samples ≥ 14.8
- OYD-500: Mean ± SD 56.05 ± 46.84, Median 37.28, 95% of samples ≥ 13.0
- Concentration (ng/µL):
- OGD-500: Mean ± SD 68.11 ± 55.27, Median 55.27, 95% of samples ≥ 16.0
- OGD-575: Mean ± SD 41.12 ± 24.59, Median 33.20, 95% of samples ≥ 11.2
- OXD-525: Mean ± SD 88.89 ± 74.51, Median 60.22, 95% of samples ≥ 27.6
- OYD-500: Mean ± SD 65.38 ± 55.94, Median 42.11, 95% of samples ≥ 14.8
- A260/A280 ratio:
- All formats: Mean ± SD 1.7 ± 0.1, Median 1.7
- OGD-500: 98% of samples 1.5 - 2.0
- OGD-575, OXD-525, OYD-500: 98% of samples 1.5 - 1.9
- eSensor® Warfarin Sensitivity Saliva Test Results (Correct calls):
- OGD-500 (45 samples): 100% for 2C92, 2C93, VKORC1
- OGD-575 (43 samples): 93.0% (first pass), 100% (after re-test) for 2C92, 2C93, VKORC1
- OXD-525 (45 samples): 100% for 2C92, 2C93, VKORC1
- OYD-500 (45 samples): 100% for 2C92, 2C93, VKORC1
- Yield (µg):
-
Sample Volume Tolerance Study (240 samples tested):
- DNA yield was dependent on collected volume.
- A260/A280 ratio and performance not affected by under or over spitting.
- % Correct calls before re-test: One first-pass no-call
- % Correct calls after re-test: 100%
-
Reproducibility Study (OGD-500, 354 samples combined across 4 operators and 3 sites):
- Yield (µg):
- Combined: Mean ± SD 74.62 ± 63.79, Median 60.39, 95% of samples ≥ 23.47
- Concentration (ng/µL):
- Combined: Mean ± SD 86.24 ± 77.61, Median 68.58, 95% of samples ≥ 26.74
- A260/A280:
- Combined: Mean ± SD 1.9 ± 0.1, Median 1.9, 95% of samples 1.6 - 2.2
- eSensor® Warfarin Sensitivity Saliva Test Results (Correct calls) after re-testing and investigation:
- Site 1 Operator 1 (87 samples): 100% for 2C92, 2C93, VKOR
- Site 1 Operator 2 (87 samples): 100% for 2C92, 2C93, VKOR
- Site 2 Operator 3 (90 samples): 100% for 2C92, 2C93, VKOR
- Site 3 Operator 4 (90 samples): 100% for 2C92, 2C93, VKOR
- Yield (µg):
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.
Vacutainer® Brand PPT™ Plasma Preparation Tube (K972075)
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.
Not Found
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.
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-Davis |
| Vice President Operations, Quality & Regulatory Affairs | |
| (Official Correspondent) | |
| Tel: (613) 723-5757 Ext. 238, Fax: (613) 368-4628 | |
| Email: chantal.hemens-davis@dnagenotek.com | |
| Device Proprietary | |
| Names | Oragene®·Dx |
| Formats: 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 862.1675 |
| Panel: Chemistry (75) | |
| Classification: Class II | |
| Product 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 and
Technology | Vacutainer® Brand PPT™ Plasma
Preparation Tube | Oragene-Dx | Similar | Different |
|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------|
| Description of
Intended Use | The Vacutainer® Brand PPT™
Plasma Preparation Tube with
EDTA anticoagulant and a gel
barrier material are evacuated
blood collection tubes which
provide a means of collecting,
processing and transporting blood
in a closed plastic tube. When the
Tube is used together with
Vacutainer® Brand Needles and
Holders, it is a closed system for
the collection of venous blood with
the same indications identified
here.
Blood collected in a tube
containing EDTA anticoagulant and
gel barrier material is used
primarily to provide undiluted
plasma for use in molecular
diagnostic test methods including
but not limited to PCR (Polymerase
Chain Reaction) and bDNA
(branched DNA). The specimen
may also be used for other testing
that requires and undiluted plasma
sample as determined by the
laboratory. | 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. | X | |
| Analyte | Various (including DNA) | DNA | X | |
| Sample
collection | Biological samples collected
through venous puncture into a
sterile plastic evacuated
collection tube | Non-invasive collection of biological
samples delivered into a non-sterile
plastic 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 and
Technology | Vacutainer® Brand PPT™ Plasma
Preparation Tube | Oragene-Dx | Similar | Different |
| Transport and
Stability | Store unfilled tubes at 4-25°C.
Limited excursion temperatures up
to 40°C, for a cumulative time not
to exceed 10 days, are acceptable. | Pre-collection Oragene-Dx kits can be
transported at temperatures ranging
from -20°C to 50°C | | X |
| | Whole blood may be stored in the
BD PPT™ Tube up to six (6) hours
prior to centrifugation. | Post-collection Oragene-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 24 months
Post-collection Oragene-Dx samples
can be stored at room temperature
for up to 12 months (OGD-500, OGD-
575, OYD-500) and 3 months for
OXD-525 | | |
| Suitability
for use with
molecular
diagnostic
applications | Used for testing plasma in
molecular diagnostics. | Stabilized DNA can be used in
molecular 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 | Samples
tested | Correct
calls | Incorrect
calls | No-calls | % Correct
calls |
|---------------|---------|-------------------|------------------|--------------------|----------|--------------------|
| OGD-500 | 2C92 | 45 | 45 | 0 | 0 | 100% |
| | 2C93 | 45 | 45 | 0 | 0 | 100% |
| | VKORC1 | 45 | 45 | 0 | 0 | 100% |
| OGD-575 | 2C92 | 43 | 40 | 0 | 3† | 93.0% |
| | 2C93 | 43 | 40 | 0 | 3† | 93.0% |
| | VKORC1 | 43 | 40 | 0 | 3† | 93.0% |
| OXD-525 | 2C92 | 45 | 45 | 0 | 0 | 100% |
| | 2C93 | 45 | 45 | 0 | 0 | 100% |
| | VKORC1 | 45 | 45 | 0 | 0 | 100% |
| OYD-500 | 2C92 | 45 | 45 | 0 | 0 | 100% |
| | 2C93 | 45 | 45 | 0 | 0 | 100% |
| | VKORC 1 | 45 | 45 | 0 | 0 | 100% |
| After re-test | | | | | | |
| OGD-575 | 2C92 | 43 | 43 | 0 | 0 | 100% |
| | 2C93 | 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 saliva
volume (mL) | Samples
tested | Correct
calls | Incorrect
calls | No-calls | % Correct
calls |
|------------------------------------------|-------------------|------------------|--------------------|----------|--------------------|
| 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 | Samples
tested | Correct
calls | Incorrect
calls | No-calls* | % Correct
calls |
|--------|------------|-------|-------------------|------------------|--------------------|-----------|--------------------|
| Site 1 | Operator 1 | 2C92 | 87 | 86 | 0 | 1 | 98.9% |
| | | 2C93 | 87 | 86 | 0 | 1 | 98.9% |
| | | VKOR | 87 | 86 | 0 | 1 | 98.9% |
| Site 1 | Operator 2 | 2C92 | 87 | 86 | 0 | 1 | 98.9% |
| | | 2C93 | 87 | 86 | 0 | 1 | 98.9% |
| | | VKOR | 87 | 86 | 0 | 1 | 98.9% |
| Site 2 | Operator 3 | 2C92 | 90 | 87 | 1+ | 2 | 96.7% |
| | | 2C93 | 90 | 88 | 0 | 2 | 97.8% |
| | | VKOR | 90 | 87 | 1+ | 2 | 96.7% |
| Site 3 | Operator 4 | 2C92 | 90 | 43 | 0 | 47 | 47.8% |
| | | 2C93 | 90 | 43 | 0 | 47 | 47.8% |
| | | VKOR | 90 | 43 | 0 | 47 | 47.8% |
:
First-pass
After re-testing and investigation
| | Operator | SNP | Samples
tested | Correct
calls | Incorrect
'calls | No-calls | % Correct
calls |
|--------|------------|-------|-------------------|------------------|---------------------|----------|--------------------|
| Site 1 | Operator 1 | 2C92 | 87 | 87 | 0 | 0 | 100% |
| | | 2C93 | 87 | 87 | 0 | 0 | 100% |
| | | VKOR | 87 | 87 | 0 | 0 | 100% |
| | Operator 2 | 2C92 | 87 | 87 | 0 | 0 | 100% |
| | | 2C93 | 87 | 87 | 0 | 0 | 100% |
| | | VKOR | 87 | 87 | 0 | 0 | 100% |
| Site 2 | Operator 3 | 2C92 | 90 | 90 | 0 | 0 | 100% |
| | | 2C93 | 90 | 90 | 0 | 0 | 100% |
| | | VKOR | 90 | 90 | 0 | 0 | 100% |
| Site 3 | Operator 4 | 2C92 | 90 | 90 | 0 | 0 | 100% |
| | | 2C93 | 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.
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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).
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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
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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