(178 days)
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 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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail metrics. Instead, it presents performance characteristics (reproducibility and accuracy) as evidence of the device's suitability. Based on the data provided, the implied acceptance criteria would be high percent agreement (call rate) for genotyping across different sites and conditions, and no incorrect calls (mis-calls).
Here's a table summarizing the reported device performance, interpreted as meeting implied acceptance for accuracy and call rate:
| Category | Locus | Acceptance Criteria (Implied) | Reported Device Performance (Worst Case) | Reported Device Performance (Best Case) |
|---|---|---|---|---|
| Accuracy (Agreement vs. Bi-directional Sequencing) | CYP2C9*2 | High correct call rate (>90%) with 0% mis-calls | Correct Call Rate: 67% (Mutant) | Correct Call Rate: 92% (Wild-type) |
| CYP2C9*3 | High correct call rate (>90%) with 0% mis-calls | Correct Call Rate: 88% (Heterozygous) | Correct Call Rate: 100% (Mutant) | |
| VKORC1 | High correct call rate (>90%) with 0% mis-calls | Correct Call Rate: 89% (Heterozygous) | Correct Call Rate: 97% (Mutant) | |
| All Loci | Overall Panel | Total panel read rate consistently high | Total panel read rate: 91.1% | Total panel read rate: 91.1% |
| Reproducibility (Initial Study) | CYP2C9*2 | High call rate (>90%) with 0% mis-calls | Call Rate: 89% (Site 2) | Call Rate: 94% (Site 1) |
| CYP2C9*3 | High call rate (>90%) with 0% mis-calls | Call Rate: 89% (Site 2) | Call Rate: 94% (Site 1) | |
| VKORC1 | High call rate (>90%) with 0% mis-calls | Call Rate: 89% (Site 2) | Call Rate: 94% (Site 1) | |
| Reproducibility (Extraction Method Study) | All Loci (After run 2) | High call rate (>95%) with 0% mis-calls | Call Rate: 100% (All Sites) | Call Rate: 100% (All Sites) |
| All Loci (After run 1) | High call rate (>90%) with 0% mis-calls | Call Rate: 91% (Site 1, 2) | Call Rate: 96% (Site 3) | |
| Limit of Detection (Call Rate above 40 ng/µL) | All Loci | Call rate of 95-100% with no mis-calls | Call Rate: 92% (40 ng/µL, 500 ng/µL) | Call Rate: 100% (200, 400 ng/µL) |
Note on "Acceptance Criteria": The document focuses on demonstrating performance rather than explicitly stating pre-defined thresholds the device must meet. However, the data presented, especially the 0% incorrect calls and generally high correct call rates, suggests these were the implicit criteria for acceptable performance. The "No Calls" indicate samples where a definitive genotype could not be assigned, which is different from an incorrect call.
Study Details:
-
Sample size used for the test set and the data provenance:
- Accuracy Study (Test Set): 238 samples.
- Reproducibility (Initial Study): 5 genomic DNA samples, tested in triplicate daily for 3 days at each of 3 sites (total 90 test runs per locus at site 1, 45 test runs per locus at sites 2 & 3).
- Reproducibility (Extraction Method Study): Panel of 23 blood specimens. At each of the 3 sites, each specimen was extracted and run once, with a re-test if there was a "no call."
- Limit of Detection Study: 12 cartridges per DNA concentration level.
- Data Provenance: The document does not explicitly state the country of origin for the samples or specify if the studies were retrospective or prospective. It states "All purified DNA samples were from whole blood collected using EDTA as the anticoagulant" for the accuracy study, and "aliquots of a panel of 23 blood specimens were utilized" for the extraction method reproducibility. This suggests they were clinical samples, but further detail is not provided.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth for the accuracy study was established by bi-directional sequencing analysis at an independent reference laboratory. The document does not specify the number of experts or their qualifications, but the method itself (bi-directional sequencing) is a gold standard for genetic genotyping.
- For the second reproducibility study (extraction method), the "genotypes of the DNA samples were confirmed by bidirectional sequencing." Again, the number and qualifications of experts are not specified, but the ground truth method is clear.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any human adjudication method for the test set results. The comparison is made directly between the device's genotype calls and the results from bi-directional sequencing.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a molecular diagnostic test for genotyping, not an imaging device that requires human interpretation or assistance from AI. The output of the device is a genotype call.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance studies described (reproducibility, accuracy, limit of detection) represent standalone performance of the Verigene System and Verigene Warfarin Metabolism Nucleic Acid Test. The device provides a direct genotype output, and its performance is evaluated against a ground truth without human intervention in the interpretation of the primary result. The summary states, "The Verigene Reader outputs a result based on relative levels of brightness of the wild type to mutant signals."
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth used was bi-directional DNA sequencing, which is a highly accurate molecular method for determining DNA sequences and identifying genetic variants.
-
The sample size for the training set:
- The document does not provide details on a separate "training set" or its sample size. The studies described are performance validation studies (accuracy, reproducibility, LOD) rather than studies focused on the development and training of a machine learning algorithm. The Verigene System utilizes "gold nanoparticle probe technology" and "onboard proprietary software" but does not explicitly mention a machine learning or AI component requiring a traditional training set in the context of this 510(k) summary.
-
How the ground truth for the training set was established:
- As no explicit "training set" or description of its characterization is provided in the document, there's no information on how its ground truth was established.
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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 AvenueNorthbrook, IL 60062Phone: 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 TestRegulations: 21 CFR §862.3360 - Drug Metabolizing Enzyme Genotyping System21 CFR §864.7750 - Prothrombin Time TestPanels: 91 Toxicology & 81 HematologyClassification: IIProduct codes: ODW - Cytochrome P450 2C9 (CYP450 2C9) Drug Metabolizing Enzyme Genotyping SystemODV - Vitamin K epoxide reductase complex subunit 1 (VKORC1) Genotyping SystemFor the instrument:Verigene ® SystemRegulation: 21 CFR §862.2570 - Instrumentation for Clinical Multiplex Test SystemsPanel: 75 Clinical ChemistryClassification: IIProduct code: NSU - Instrumentation for Clinical Multiplex Test Systems |
| Common names | For the assays:warfarin metabolism CYP2C92warfarin panel CYP2C93warfarin VKORC1For 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. |
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| Predicate device | Third Wave Technologies, Inc., Invader® UGT1A1 Molecular Assay (K051824) |
|---|---|
| Devicedescriptions | The Verigene System is an in vitro diagnostic device for processing and genotyping multiplegenes in a DNA sample. The Verigene System consists of two instruments, the VerigeneProcessor and the Verigene Reader, and utilizes single-use, disposable Test Cartridges toprocess 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 andVKORC1). After extracted and purified DNA, mixed with hybridization buffer, is loaded intothe sample well of the Test Cartridge, it is ready for processing and is inserted into theVerigene Processor. An internal barcode reader reads the cartridge ID and sends theinformation to the Verigene Reader. From this information, the Verigene Reader establishesthe 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 syntheticmediator target-specific oligonucleotide is included with the test-specific sample buffer toform a hybridization "sandwich" with the gene sequence of interest. Washing stepsfollowing the target hybridization remove the unbound DNA from the hybridization chamber.A probe, composed of a gold nanoparticle with covalently bound oligonucleotidescomplementary to a sequence on the intermediate oligonucleotide, is introduced after thetarget wash. After the probe hybridization is completed, a series of washing steps removethe unbound probe from the hybridization chamber. A two-part signal enhancement reagentis added to the hybridization chamber and reacts with the gold nanoparticle to amplify thesignal for the Verigene Reader scanning and analysis. | |
| Upon completion of the genotyping process, the user removes the Test Cartridge from theVerigene Processor which is now ready for the next test. | |
| Once the reagent portion of the Test Cartridge is removed by the user, the substrate isinserted into the Verigene Reader. The Verigene Reader illuminates the signal-enhancednanoparticles specifically bound to either the wild type or mutant captures for the gene. Aphotosensor reads the relative brightness of each spot and the Verigene Reader outputs aresult based on relative levels of brightness of the wild type to mutant signals. | |
| Comparison totechnological | The following is a comparison of the Nanosphere, Inc., Verigene System to the Third WaveTechnologies, Inc., Invader® UGT1A1 Molecular Assay: |
| Characteristic | Third Wave Technologies, Inc.,Invader® UGT1A1 MolecularAssay | Nanosphere, Inc., Verigene®Warfarin Metabolism NucleicAcid Test |
|---|---|---|
| DNA sequencedetection | Detects specific DNA sequencesthrough direct recognition of DNAtargets | Same as predicate |
| Reactionconditions | 1) No thermal cycling –isothermic reaction2) Utilizes signal amplification3) Reactions occur in multipleplastic microtiter wells | 1) Same as predicate2) Same as predicate3) Reactions occur on a singleglass slide using microfluidics,with up to 32 cartridges (slides)hybridized and enhancedsimultaneously |
| Assay results | Assay signal results areinterpreted by a software programand are assigned a genotype thatis presented to the end-user in areport format. | Same as predicate |
technological
features of the
predicate device
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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 | SamplesTested | CorrectCalls | IncorrectCalls(Mis-Calls) | NoCalls | Call Rate(% agreement) |
|---|---|---|---|---|---|---|
| Site 1 | 2C9*2 | 90 | 85 | 0 | 5* | 94% |
| 2C9*3 | 90 | 85 | 0 | 5* | 94% | |
| VKORC1 | 90 | 85 | 0 | 5* | 94% | |
| Site 2 | 2C9*2 | 45 | 40 | 0 | 5* | 89% |
| 2C9*3 | 45 | 40 | 0 | 5* | 89% | |
| VKORC1 | 45 | 40 | 0 | 5* | 89% | |
| Site 3 | 2C9*2 | 45 | 41 | 0 | 4 | 91% |
| 2C9*3 | 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 | SamplesTested | Run | GenotypingCalls Made | CorrectCalls | IncorrectCalls(Mis-Calls) | Call Rate(% agreement) |
|---|---|---|---|---|---|---|
| Site 1 | 23 | Afterrun 1 | 21 | 21 | 0 | 91% |
| Afterrun 2 | 23 | 23 | 0 | 100% | ||
| Site 2 | 23 | Afterrun 1 | 21 | 21 | 0 | 91% |
| Afterrun 2 | 23 | 23 | 0 | 100% | ||
| Site 3 | 23 | Afterrun 1 | 22 | 22 | 0 | 96% |
| Afterrun 2 | 23 | 23 | 0 | 100% |
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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) | IncorrectCall 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) | IncorrectCall Rate(Mis-Calls) | Correct Call Rate[% agreement](No Calls) | ||
|---|---|---|---|---|---|---|
| Sequenceanalysis | 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
| Sequenceanalysis | Wild-type(wt) | Heterozygous(het) | Mutant(mut) | IncorrectCall 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
| DNAConcentration | Number ofCartridges | CorrectCalls | IncorrectCalls(Mis-Calls) | NoCalls | 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 | |
|---|---|---|---|---|
| Othercharacteristics ofthe VerigeneWarfarinMetabolismNucleic 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 theexpiration date printed on the label.• The Sample Buffer is to be stored from 2°C to 8°C until theexpiration date printed on the label.• Neither the Test Cartridges nor the Sample Buffer should be frozen. | |||
| Precautions andwarnings | In the CYP2C9 gene, additional raremutations other than R149C (CYP2C92)and I359L (CYP2C93) have beenobserved. These rare CYP2C9 alleles arenot detected by this test. NOTE: Theprevalence of these additional allelesis low and there is insufficient information inthe scientific literature to predict the impactthis polymorphism will have on anindividual's sensitivity to warfarin. | In the VKORC1gene, additional rarepolymorphisms otherthan 1173C>T havebeen observed. Theserare VKORC1 allelesare not detected by thistest. |
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.
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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).
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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
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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
Page 1 of 1
§ 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.