(178 days)
Not Found
No
The device description and performance studies focus on standard molecular diagnostic techniques (hybridization, signal amplification, photosensor reading) and do not mention any AI/ML algorithms for data analysis or interpretation. The analysis is based on relative brightness levels, which is a deterministic process.
No.
The device is an in vitro diagnostic device used to aid in the identification of patients at risk for increased warfarin sensitivity by detecting and genotyping specific alleles and polymorphisms. It does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" states, "The Verigene Warfarin Metabolism Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of the *2 and *3 alleles of the CYP2C9 gene and a single-point polymorphism (C to T at position 1173) of the VKORC1 gene, ... as an aid in the identification of patients at risk for increased warfarin sensitivity." It also explicitly states, "The Verigene System is an in vitro diagnostic device..."
No
The device description explicitly states that the Verigene System consists of two instruments, the Verigene Processor and the Verigene Reader, which are hardware components. While these instruments have onboard software, the system is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Verigene Warfarin Metabolism Nucleic Acid Test is an in vitro diagnostic..." and "The Verigene System is an in vitro diagnostic device...".
The "Device Description" also reiterates: "The Verigene System is an in vitro diagnostic device...".
These statements clearly indicate that the device is intended for use outside of the body to examine specimens (in this case, whole blood samples) to provide information for the diagnosis or treatment of a condition.
N/A
Intended Use / Indications for Use
• The Verigene ® Warfarin Metabolism Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of the *2 and *3 alleles of the CYP2C9 gene and a single-point polymorphism (C to T at position 1173) of the VKORC1 gene, from EDTA-anticoagulated whole blood samples, as an aid in the identification of patients at risk for increased warfarin sensitivity. The test is intended to be used on the Verigene System.
• The Verigene ® System is an in vitro diagnostic device intended for processing and genotyping multiple genes in a DNA sample utilizing gold nanoparticle probe technology. The Verigene System consists of the Verigene Processor and the Verigene Reader, each with its own onboard proprietary software. The Verigene System is intended to be used by experienced laboratory professionals with training on basic laboratory techniques and on the use of the system components.
Product codes (comma separated list FDA assigned to the subject device)
ODW, ODV, NSU
Device Description
The Verigene System is an in vitro diagnostic device for processing and genotyping multiple genes in a DNA sample. The Verigene System consists of two instruments, the Verigene Processor and the Verigene Reader, and utilizes single-use, disposable Test Cartridges to process and genotype multiple genes in a DNA sample in approximately 1½ hours.
The analysis sequence is the same for each of the three tests (i.e., CYP2C9*2 and *3 and VKORC1). After extracted and purified DNA, mixed with hybridization buffer, is loaded into the sample well of the Test Cartridge, it is ready for processing and is inserted into the Verigene Processor. An internal barcode reader reads the cartridge ID and sends the information to the Verigene Reader. From this information, the Verigene Reader establishes the hybridization parameters and starts the hybridization process.
The genotyping process occurs with a hybridization of the target analyte to a synthetic gene-specific oligonucleotide capture strand on the Test Cartridge's substrate. A synthetic mediator target-specific oligonucleotide is included with the test-specific sample buffer to form a hybridization "sandwich" with the gene sequence of interest. Washing steps following the target hybridization remove the unbound DNA from the hybridization chamber. A probe, composed of a gold nanoparticle with covalently bound oligonucleotides complementary to a sequence on the intermediate oligonucleotide, is introduced after the target wash. After the probe hybridization is completed, a series of washing steps remove the unbound probe from the hybridization chamber. A two-part signal enhancement reagent is added to the hybridization chamber and reacts with the gold nanoparticle to amplify the signal for the Verigene Reader scanning and analysis.
Upon completion of the genotyping process, the user removes the Test Cartridge from the Verigene Processor which is now ready for the next test.
Once the reagent portion of the Test Cartridge is removed by the user, the substrate is inserted into the Verigene Reader. The Verigene Reader illuminates the signal-enhanced nanoparticles specifically bound to either the wild type or mutant captures for the gene. A photosensor reads the relative brightness of each spot and the Verigene Reader outputs a result based on relative levels of brightness of the wild type to mutant signals.
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
experienced laboratory professionals with training on basic laboratory techniques and on the use of the system components.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Reproducibility Study 1:
- Study Type: Reproducibility
- Sample Size: 90 samples per locus at Site 1, 45 samples per locus at Site 2, 45 samples per locus at Site 3. Total of 5 genomic DNA samples, covering all possible genotypes for all three alleles, each tested in triplicate on a daily basis for three days.
- Key Results:
- Site 1: CYP2C92, 2C93, VKORC1 all showed 94% call rate.
- Site 2: CYP2C92, 2C93, VKORC1 all showed 89% call rate.
- Site 3: CYP2C92, 2C93, VKORC1 all showed 91% call rate.
- No incorrect calls (mis-calls) were observed.
Reproducibility Study 2 (DNA Extraction Methods):
- Study Type: Reproducibility (evaluated DNA extraction methods)
- Sample Size: Aliquots of a panel of 23 blood specimens were utilized at each of 3 sites.
- Data Source: Genotypes confirmed by bidirectional sequencing.
- Key Results:
- Site 1: After run 1: 21 calls made, 21 correct, 0 incorrect, 91% call rate. After run 2: 23 calls made, 23 correct, 0 incorrect, 100% call rate.
- Site 2: After run 1: 21 calls made, 21 correct, 0 incorrect, 91% call rate. After run 2: 23 calls made, 23 correct, 0 incorrect, 100% call rate.
- Site 3: After run 1: 22 calls made, 22 correct, 0 incorrect, 96% call rate. After run 2: 23 calls made, 23 correct, 0 incorrect, 100% call rate.
- No mis-calls were observed.
Accuracy (compared to bi-directional DNA sequencing):
- Study Type: Method comparison (Accuracy)
- Sample Size: 238 samples analyzed.
- Data Source: Purified DNA samples from whole blood collected with EDTA. Reference method was bi-directional sequencing analysis at an independent reference laboratory.
- Key Results:
- CYP2C9*2: 0% incorrect call rate. Correct call rate: Wild-type 92% (15 No Calls), Heterozygous 87% (5 No Calls), Mutant 67% (1 No Call).
- CYP2C9*3: 0% incorrect call rate. Correct call rate: Wild-type 91% (17 No Calls), Heterozygous 88% (4 No Calls), Mutant 100% (0 No Calls).
- VKORC1 1173: 0% incorrect call rate. Correct call rate: Wild-type 91% (8 No Calls), Heterozygous 89% (12 No Calls), Mutant 97% (1 No Call).
- Overall panel read rate: 91.1% (=214/235).
Limit of Detection (analytical sensitivity):
- Study Type: DNA concentration study (analytical sensitivity)
- Sample Size: 12 cartridges per concentration level.
- Key Results:
- 30 ng/µL: 75% call rate.
- 40 ng/µL: 92% call rate.
- 200 ng/µL: 100% call rate.
- 400 ng/µL: 100% call rate.
- 500 ng/µL: 92% call rate.
- No mis-calls were made across the studied concentration range.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Call Rate, Correct Call Rate, Incorrect Call Rate (Mis-Calls)
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.
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
§ 862.3360 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
nosphere
SEP 1 7 2007
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.
| 510(k) number | K070804 |
|---|---|
| Summary preparation date | September 11, 2007 |
| Submitted by | Nanosphere, Inc. |
| 4088 Commercial Avenue | |
| Northbrook, IL 60062 | |
| Phone: 847-400-9000 Fax: 847-400-9199 | |
| Contact | Sue Kent - Manager, Clinical & Regulatory Affairs |
| Proprietary names and classifications | For the assay: |
| Verigene ® Warfarin Metabolism Nucleic Acid Test | |
| Regulations: 21 CFR §862.3360 - Drug Metabolizing Enzyme Genotyping System | |
| 21 CFR §864.7750 - Prothrombin Time Test | |
| Panels: 91 Toxicology & 81 Hematology | |
| Classification: II | |
| Product codes: ODW - Cytochrome P450 2C9 (CYP450 2C9) Drug Metabolizing Enzyme Genotyping System | |
| ODV - Vitamin K epoxide reductase complex subunit 1 (VKORC1) Genotyping System |
For the instrument:
Verigene ® System
Regulation: 21 CFR §862.2570 - Instrumentation for Clinical Multiplex Test Systems
Panel: 75 Clinical Chemistry
Classification: II
Product code: NSU - Instrumentation for Clinical Multiplex Test Systems |
| Common names | For the assays:
warfarin metabolism CYP2C92
warfarin panel CYP2C93
warfarin VKORC1
For the instrument:
Bench-top molecular diagnostics workstation |
| Intended uses | • The Verigene ® Warfarin Metabolism Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of the *2 and *3 alleles of the CYP2C9 gene and a single-point polymorphism (C to T at position 1173) of the VKORC1 gene, from EDTA-anticoagulated whole blood samples, as an aid in the identification of patients at risk for increased warfarin sensitivity. The test is intended to be used on the Verigene System.
• The Verigene ® System is an in vitro diagnostic device intended for processing and genotyping multiple genes in a DNA sample utilizing gold nanoparticle probe technology. The Verigene System consists of the Verigene Processor and the Verigene Reader, each with its own onboard proprietary software. The Verigene System is intended to be used by experienced laboratory professionals with training on basic laboratory techniques and on the use of the system components. |
1
| Predicate device | Third Wave Technologies, Inc., Invader® UGT1A1 Molecular Assay (K051824) |
|---|---|
| Device | |
| descriptions | The Verigene System is an in vitro diagnostic device for processing and genotyping multiple |
| genes in a DNA sample. The Verigene System consists of two instruments, the Verigene | |
| Processor and the Verigene Reader, and utilizes single-use, disposable Test Cartridges to | |
| process and genotype multiple genes in a DNA sample in approximately 1½ hours. | |
| The analysis sequence is the same for each of the three tests (i.e., CYP2C9*2 and *3 and | |
| VKORC1). After extracted and purified DNA, mixed with hybridization buffer, is loaded into | |
| the sample well of the Test Cartridge, it is ready for processing and is inserted into the | |
| Verigene Processor. An internal barcode reader reads the cartridge ID and sends the | |
| information to the Verigene Reader. From this information, the Verigene Reader establishes | |
| the hybridization parameters and starts the hybridization process. | |
| The genotyping process occurs with a hybridization of the target analyte to a synthetic gene- | |
| specific oligonucleotide capture strand on the Test Cartridge's substrate. A synthetic | |
| mediator target-specific oligonucleotide is included with the test-specific sample buffer to | |
| form a hybridization "sandwich" with the gene sequence of interest. Washing steps | |
| following the target hybridization remove the unbound DNA from the hybridization chamber. | |
| A probe, composed of a gold nanoparticle with covalently bound oligonucleotides | |
| complementary to a sequence on the intermediate oligonucleotide, is introduced after the | |
| target wash. After the probe hybridization is completed, a series of washing steps remove | |
| the unbound probe from the hybridization chamber. A two-part signal enhancement reagent | |
| is added to the hybridization chamber and reacts with the gold nanoparticle to amplify the | |
| signal for the Verigene Reader scanning and analysis. | |
| Upon completion of the genotyping process, the user removes the Test Cartridge from the | |
| Verigene Processor which is now ready for the next test. | |
| Once the reagent portion of the Test Cartridge is removed by the user, the substrate is | |
| inserted into the Verigene Reader. The Verigene Reader illuminates the signal-enhanced | |
| nanoparticles specifically bound to either the wild type or mutant captures for the gene. A | |
| photosensor reads the relative brightness of each spot and the Verigene Reader outputs a | |
| result based on relative levels of brightness of the wild type to mutant signals. | |
| Comparison to | |
| technological | The following is a comparison of the Nanosphere, Inc., Verigene System to the Third Wave |
| Technologies, Inc., Invader® UGT1A1 Molecular Assay: |
| Characteristic | Third Wave Technologies, Inc.,
Invader® UGT1A1 Molecular
Assay | Nanosphere, Inc., Verigene®
Warfarin Metabolism Nucleic
Acid Test |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DNA sequence
detection | Detects specific DNA sequences
through direct recognition of DNA
targets | Same as predicate |
| Reaction
conditions | 1) No thermal cycling –
isothermic reaction
-
Utilizes signal amplification
-
Reactions occur in multiple
plastic microtiter wells | 1) Same as predicate -
Same as predicate
-
Reactions occur on a single
glass slide using microfluidics,
with up to 32 cartridges (slides)
hybridized and enhanced
simultaneously |
| Assay results | Assay signal results are
interpreted by a software program
and are assigned a genotype that
is presented to the end-user in a
report format. | Same as predicate |
technological
features of the
predicate device
2
Reproducibility -
Performance
characteristics
In an initial reproducibility study at each of three sites, five genomic DNA samples, covering all possible genotypes for all three alleles, were each tested in triplicate on a daily basis by the same operator for three days. One site performed the same reproducibility testing twice each day, using two different operators. The table below shows the number of samples tested, correct calls, incorrect calls, and percent agreement (or call rate) by locus for each of the three sites.
| Site | Locus | Samples
Tested | Correct
Calls | Incorrect
Calls
(Mis-Calls) | No
Calls | Call Rate
(% agreement) |
|--------|--------|-------------------|------------------|-----------------------------------|-------------|----------------------------|
| Site 1 | 2C92 | 90 | 85 | 0 | 5 | 94% |
| | 2C93 | 90 | 85 | 0 | 5 | 94% |
| | VKORC1 | 90 | 85 | 0 | 5* | 94% |
| Site 2 | 2C92 | 45 | 40 | 0 | 5 | 89% |
| | 2C93 | 45 | 40 | 0 | 5 | 89% |
| | VKORC1 | 45 | 40 | 0 | 5* | 89% |
| Site 3 | 2C92 | 45 | 41 | 0 | 4 | 91% |
| | 2C93 | 45 | 41 | 0 | 4 | 91% |
| | VKORC1 | 45 | 41 | 0 | 4 | 91% |
Initial reproducibility results
*includes 1 pre-insertion error
In a second reproducibility study (see table below) that evaluated three common DNA extraction methods, aliquots of a panel of 23 blood specimens were utilized. At each of the 3 sites, 1 operator extracted the DNA from each of the 23 aliquots of blood and ran the assay. Each site used a different DNA extraction procedure/kit. 3 lots of cartridges were tested. 1 re-test run was performed if there was a "no call" on the first run but no mis-calls were observed. The genotypes of the DNA samples were confirmed by bidirectional sequencing. The genotypes of the 23 samples included:
- 2C9*2: 18 wild type, 4 heterozygous, 1 mutant
- 2C9*3: 20 wild type, 3 heterozygous, 0 mutant
- VKORC1: 9 wild type, 11 heterozygous, 3 mutant
Extraction method reproducibility results
| Site | Samples
Tested | Run | Genotyping
Calls Made | Correct
Calls | Incorrect
Calls
(Mis-Calls) | Call Rate
(% agreement) |
|--------|-------------------|----------------|--------------------------|------------------|-----------------------------------|----------------------------|
| Site 1 | 23 | After
run 1 | 21 | 21 | 0 | 91% |
| | | After
run 2 | 23 | 23 | 0 | 100% |
| Site 2 | 23 | After
run 1 | 21 | 21 | 0 | 91% |
| | | After
run 2 | 23 | 23 | 0 | 100% |
| Site 3 | 23 | After
run 1 | 22 | 22 | 0 | 96% |
| | | After
run 2 | 23 | 23 | 0 | 100% |
3
Accuracy (percent agreement compared to bi-directional DNA sequencing) -
A total of 238 samples were analyzed using the Verigene Warfarin Metabolism Nucleic Acid Test at three sites and by bi-directional sequencing analysis at an independent reference laboratory (see results in the tables below). All purified DNA samples were from whole blood collected using EDTA as the anticoagulant. These data are based on the original run only (i.e., no re-testing was performed). Three Verigene cartridges were defective and failed to run due to pre-insertion errors.
| Sequence analysis | | Wild-
type
(wt) | Heterozygous
(het) | Mutant
(mut) | Incorrect
Call Rate
(Mis-Calls) | Correct Call Rate
[% agreement]
(No Calls) |
|-------------------|-----|-----------------------|-----------------------|-----------------|---------------------------------------|--------------------------------------------------|
| | wt | 176 | 0 | 0 | 0% (0) | 92% (15) |
| | het | 0 | 35 | 0 | 0% (0) | 87% (5) |
| | mut | 0 | 0 | 2 | 0% (0) | 67% (1) |
CYP2C9*2 method comparison results
CYP2C9*3 method comparison results
| | | Wild-
type
(wt) | Heterozygous
(het) | Mutant
(mut) | Incorrect
Call Rate
(Mis-Calls) | Correct Call Rate
[% agreement]
(No Calls) |
|----------------------|-----|-----------------------|-----------------------|-----------------|---------------------------------------|--------------------------------------------------|
| Sequence
analysis | wt | 182 | 0 | 0 | 0% (0) | 91% (17) |
| | het | 0 | 30 | 0 | 0% (0) | 88% (4) |
| | mut | 0 | 0 | 1 | 0% (0) | 100% (0) |
VKORC1 1173 method comparison results
| Sequence
analysis | Wild-
type
(wt) | Heterozygous
(het) | Mutant
(mut) | Incorrect
Call Rate
(Mis-Calls) | Correct Call Rate
[% agreement]
(No Calls) |
|----------------------|-----------------------|-----------------------|-----------------|---------------------------------------|--------------------------------------------------|
| wt | 79 | 0 | 0 | 0% (0) | 91% (8) |
| het | 0 | 97 | 0 | 0% (0) | 89% (12) |
| mut | 0 | 0 | 34 | 0% (0) | 97% (1) |
The Verigene Warfarin Metabolism Nucleic Acid Test results will be reported only if calls are made for all three targets (i.e., the panel must be complete, based on calls made for CYP2C92, CYP2C93, and VKORC1 calls). If only one or two allele calls are made, the entire test's results are not reported on the screen or printout.
Therefore, from an overall panel view, the total panel read rate was 91.1% (=214/235).
Limit of Detection (analytical sensitivity)-
The table below shows the results of a DNA concentration study. When DNA concentrations outside of the range of 40 ng/pL - 400 ng/pL are studied, no mis-calls are made but the call rate decreases. At 40 ng/μL, the call rate is 92%.
Limit of detection study results
| DNA
Concentration | Number of
Cartridges | Correct
Calls | Incorrect
Calls
(Mis-Calls) | No
Calls | Call Rate
(% agreement) |
|----------------------|-------------------------|------------------|-----------------------------------|-------------|----------------------------|
| 30 ng/µL | 12 | 9 | 0 | 3 | 75% |
| 40 ng/µL | 12 | 11 | 0 | 1 | 92% |
| 200 ng/µL | 12 | 12 | 0 | 0 | 100% |
| 400 ng/µL | 12 | 12 | 0 | 0 | 100% |
| 500 ng/µL | 12 | 11 | 0 | 1 | 92% |
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| Characteristic | CYP2C9*2 | CYP2C9*3 | VKORC1 | |
|---|---|---|---|---|
| Other | ||||
| characteristics of | ||||
| the Verigene | ||||
| Warfarin | ||||
| Metabolism | ||||
| Nucleic Acid Test | Interferences | Performance not affected by | ||
| • magnetic beads | ||||
| • heparin | ||||
| • hemoglobin | ||||
| • magnesium chloride | ||||
| • lithium chloride | ||||
| • other possible interferences are not known. | ||||
| Reagent stability | • The Test Cartridges are to be stored from 2°C to 8°C until the | |||
| expiration date printed on the label. | ||||
| • The Sample Buffer is to be stored from 2°C to 8°C until the | ||||
| expiration date printed on the label. | ||||
| • Neither the Test Cartridges nor the Sample Buffer should be frozen. | ||||
| Precautions and | ||||
| warnings | In the CYP2C9 gene, additional rare | |||
| mutations other than R149C (CYP2C9*2) | ||||
| and I359L (CYP2C9*3) have been | ||||
| observed. These rare CYP2C9 alleles are | ||||
| not detected by this test. NOTE: The | ||||
| prevalence of these additional alleles | ||||
| is low and there is insufficient information in | ||||
| the scientific literature to predict the impact | ||||
| this polymorphism will have on an | ||||
| individual's sensitivity to warfarin. | In the VKORC1 | |||
| gene, additional rare | ||||
| polymorphisms other | ||||
| than 1173C>T have | ||||
| been observed. These | ||||
| rare VKORC1 alleles | ||||
| are not detected by this | ||||
| test. |
Conclusion
The above pre-clinical and clinical test results support the safety and effectiveness of the devices -- the Verigene System and Verigene Warfarin Metabolism Nucleic Acid Test.
Verigene® is a registered trademark of Nanosphere, Inc.
Verigene® is a registered trademark of Nanosphere, Inc.
Invader® is a registered trademark of Third Wave Technologies, Inc.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Nanosphere, Inc c/o Ms. Sue Kent 4088 Commercial Avenue Northbrook, IL 60062
SEP 17 2007
Re: K070804
Trade/Device Name: Verigene Warfarin Metabolism Nucleic Acid Test, Verigene System Regulation Number: 21 CFR 862.3360 Regulation Name: Drug metabolizing enzyme genotyping system Regulatory Class: Class II Product Code: ODW, ODV, NSU Dated: August 7, 2007 Received: August 8, 2007
Dear Ms. Kent:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
6
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for use
510(k) Number (if known): K070804
Device Name: Verigene® System
Indications for Use: The Verigene System is an in vitro diagnostic device intended for processing and genotyping multiple genes in a DNA sample utilizing gold nanoparticle probe technology. The Verigene System consists of the Verigene Processor and the Verigene Reader, each with its own onboard proprietary software.
Device Name: Verigene Warfarin Metabolism Nucleic Acid Test
Indications for Use: The Verigene Warfarin Metabolism Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of the *2 and *3 alleles of the CYP2C9 gene and a single-point polymorphism (C to T at position 1173) of the VKORC1 gene, from EDTAanticoagulated whole blood samples, as an aid in the identification of patients at risk for increased warfarin sensitivity. The test is intended to be used on the Verigene System.
Prescription Use X (Part 21 CFR 801 Subpart D)
and/or
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
ision Sign-Off
്ffice of In Vitro Diagnostic Device Evaluation and Safety
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