Who can help prepare an FDA 510(k) submission like VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST

Q: Who is the manufacturer of VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST?

Nanosphere, Inc. filed the 510(k) submission for VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST (K070597).

Q: What is the FDA product code for VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST?

NSU. It is classified under 21 CFR 862.2570 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST?

510(k) clearance (submission type: Traditional).

K070597 · Nanosphere, Inc. · NSU · Oct 11, 2007 · Clinical Chemistry

Device Facts

Record ID	K070597
Device Name	VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST
Applicant	Nanosphere, Inc.
Product Code	NSU · Clinical Chemistry
Decision Date	Oct 11, 2007
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.2570
Device Class	Class 2

Intended Use

The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the Verigene® System. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210 of the human Factor II gene (F2; prothrombin gene)) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the Verigene® System. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5, 10-methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the Verigene® System.

Device Story

Verigene System is a bench-top molecular diagnostics workstation for automated genotyping of DNA samples. Input: isolated genomic DNA loaded into disposable Test Cartridges. Operation: hybridization of target DNA to synthetic gene-specific oligonucleotide capture strands on cartridge substrate; formation of 'sandwich' complex with mediator oligonucleotide; binding of gold nanoparticle probes; signal enhancement via two-part reagent. Reader illuminates nanoparticles; photosensor measures relative brightness of wild-type vs. mutant spots. Output: genotype result based on relative brightness. Used in clinical laboratories by trained professionals. Benefits: automates complex molecular analysis; provides rapid (approx. 1.5 hours) genotyping to aid diagnosis of hereditary thrombophilia factors.

Clinical Evidence

Method comparison study using 287 clinical samples (68% from 'rule-out thrombophilia' patients) compared Verigene results to bi-directional DNA sequencing. Results showed 100% Positive Percent Agreement (95% CI: 98.9-100.0%) and 100% Negative Percent Agreement (95% CI: 98.9-100.0%). No clinical data provided; bench testing only.

Technological Characteristics

System uses disposable cartridges with synthetic oligonucleotide capture strands and gold nanoparticle probes. Detection via evanescent wave light scatter. Requires isolated genomic DNA (40-400 ng/μL). Connectivity: Up to 8 processors per reader. Calibration required for temperature control system. Software performs automated on-line quality monitoring of fluidics, instrument, and reagent integrity.

Indications for Use

Indicated for patients with suspected thrombophilia requiring detection and genotyping of Factor V Leiden (G1691A), Factor II (G20210A), or MTHFR (C677T) mutations using isolated genomic DNA from whole blood.

Regulatory Classification

Identification

Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.

The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems."

Predicate Devices

Roche Diagnostics Corporation LightCycler® Instrument (K033734)
Roche Diagnostics Corporation Factor V Leiden Kit (K033607)
Roche Diagnostics Corporation Factor II (Prothrombin) G20210A Kit (K033612)

Related Devices

K070804 — VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST · Nanosphere, Inc. · Sep 17, 2007
K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) · Nanosphere, Inc. · Nov 6, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ OCT 1 1 2007 Nanosphere # 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: | K070597 | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary preparation date: | October 5, 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: | For instrument: Verigene® System For the assays: Verigene HC Nucleic Acid Test Verigene F5 / F2 / MTHFR Nucleic Acid Test Verigene F5 / F2 Nucleic Acid Test Verigene F2 Nucleic Acid Test Verigene F5 Nucleic Acid Test Verigene MTHFR Nucleic Acid Test | | Common names: | For the instrument: Bench-top molecular diagnostics workstation For the assays: F2, FII, Factor II, coagulation factor II, prothrombin F5, FV, Factor V, coagulation factor V MTHFR, methylenetetrahydrofolate reductase Hypercoagulation panel HC panel | | 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. Clinicians use one or more of the three genes ( F5, F2, MTHFR ) and their associated single nucleotide polymorphisms (SNPs) to help diagnose patients' hereditary contributory factors in forming blood clots (thrombi). On the Verigene System, hypercoagulation testing can include one or more of three genotypes that are associated with hypercoagulation (i.e., thrombophilia). These tests use | {1}------------------------------------------------ The analysis sequence is the same for each of the three tests (i.e., F2, F5, MTHFR). 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. · The Verigene® System is a bench-top molecular diagnostics workstation that Intended uses: automates the in vitro diagnostic analysis and detection of nucleic acids using gold nanoparticle probe technology. 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. · The Verigene F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691: also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the Verigene System. · The Verigene F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the Verigene System. · The Verigene MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia. from isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the Verigene System. Predicate devices: For the instrument: Roche Diagnostics Corporation LightCycler® Instrument (K033734) For the assays: Roche Diagnostics Corporation Factor V Leiden Kit (K033607) Roche Diagnostics Corporation Factor II (Prothrombin) G20210A Kit (K033612) {2}------------------------------------------------ ### Comparison to Technological Features of the Predicate Device | Characteristic | Verigene System | LightCycler Instrument | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | Enzymatic manipulation of sample | No (chemical amplification of reporter signal) | Yes (DNA amplification via PCR) | | Detection procedure | Single-image sensor where nanoparticles are illuminated using a fixed- wavelength light source | Optical detection of stimulated fluorescence | | Heating method | 1) Sonication horn for sample denaturation 2) Temperature- controlled heat block in contact with substrate | Hot air cycling with glass capillaries | | Detection chemistry | SNP discrimination via oligonucleotide probes; detection via evanescent wave light scatter with nanoparticles | Paired hybridization probes using fluorescence resonance energy transfer (FRET) | | Primary operational components | Integrated hybridization/ washing for walkaway assay hybridization and detection. Automated array image acquisition and results interpretation. | Integrated thermocycler and microvolume fluorimeter for walkaway PCR amplification and detection. | | Specimen type | Purified nucleic acids | Purified nucleic acids | | Specimen preparation | DNA isolation performed off-line. Fragmentation of DNA performed onboard. | Performed off line | | Sample positions | 4 – 32 | 32 | | Sample size | 25 μl | 10-20 μL in glass capillaries | | Number of optical detection channels | One fixed-wavelength imager | Three with fixed wavelengths (530 nm, 640 nm, 710 nm) | | Analysis Time | 2 minutes | Detection occurs at defined intervals during PCR cycle and can be viewed in real-time | | User interface | Embedded software in closed system, integrated graphical user | PC with instrument- specific software (LightCycler version 3.5 or higher) | Performance characteristics for Verigene F5 / F2 / MTHFR Nucleic Acid Tests: ### Reproducibility Study #1: Three DNA samples, that had been whole genome amplified, were tested in duplicate twice per day by two operators at each of three test sites. Six lots of test cartridges were utilized (two lots at each site). Site 1 performed this testing for 10 non-consecutive days; Sites 2 and 3 performed the testing for 5 nonconsecutive days. | F5 | Site | Correct Calls (%) | No Calls (%) | Mis-calls (%) | |------------|------|-------------------|--------------|---------------| | Operator A | 1 | 117 (99.2%)* | 1 (0.8%) | 0 (0.0%) | | Operator B | 1 | 114 (99.1%)* | 1 (0.9%) | 0 (0.0%) | | Operator C | 2 | 59 (98.3%) | 1 (1.7%) | 0 (0.0%) | | Operator D | 2 | 59 (98.3%) | 1 (1.7%) | 0 (0.0%) | | Operator E | 3 | 58 (100.0%)* | 0 (0.0%) | 0 (0.0%) | | Operator F | 3 | 57 (96.6%)* | 2 (3.4%) | 0 (0.0%) | {3}------------------------------------------------ | F2 | Site | Correct Calls (%) | No Calls (%) | Mis-calls (%) | |------------|------|-------------------|--------------|---------------| | Operator A | 1 | 117 (99.2%)* | 1 (0.8%) | 0 (0.0%) | | Operator B | 1 | 114 (99.1%)* | 1 (0.9%) | 0 (0.0%) | | Operator C | 2 | 58 (96.7%) | 2 (3.3%) | 0 (0.0%) | | Operator D | 2 | 59 (98.3%) | 1 (1.7%) | 0 (0.0%) | | Operator E | 3 | 58 (100.0%)* | 0 (0.0%) | 0 (0.0%) | | Operator F | 3 | 55 (93.2%)* | 4 (6.8%) | 0 (0.0%) | | MTHFR | Site | Correct Calls (%) | No Calls (%) | Mis-calls (%) | |------------|------|-------------------|--------------|---------------| | Operator A | 1 | 117 (99.2%)* | 1 (0.8%) | 0 (0.0%) | | Operator B | 1 | 113 (98.3%)* | 2 (1.7%) | 0 (0.0%) | | Operator C | 2 | 58 (96.7%) | 2 (3.3%) | 0 (0.0%) | | Operator D | 2 | 58 (96.7%) | 2 (3.3%) | 0 (0.0%) | | Operator E | 3 | 58 (100.0%)* | 0 (0.0%) | 0 (0.0%) | | Operator F | 3 | 56 (94.9%)* | 3 (5.1%) | 0 (0.0%) | *Ten cartridges (7 at Site 1 and 3 at Site 3) failed to run. ### Reproducibility Study #2: Reproducibility Ottablility testing included 4 studies, each using a different A Subsequent reprodublity tooling invidued + oration varators at 3 sites. | Study Description | Summary of Results | | | | |----------------------------------------------------------------|--------------------|-----|-----|-------| | Each of the three test sites ran the same sample in duplicate. | 3 Sites | F5 | F2 | MTHFR | | | Site 1 | HET | HET | HET | | | | HET | HET | HET | | | Site 2 | HET | HET | HET | | | | HET | HET | HET | | | Site 3 | HET | HET | HET | | | | HET | HET | HET | | One operator analyzed the same sample in duplicate each day for three days. | 3 Days | F2 | F5 | MTHFR | |-----------------------------------------------------------------------------------|--------|----|-----|-------| | | Day 1 | WT | HET | WT | | | | WT | HET | WT | | | Day 2 | WT | HET | WT | | | | WT | HET | WT | | | Day 3 | WT | HET | WT | | | | WT | HET | WT | | Three operators at one site each analyzed the same sample in duplicate. | 3 Operators | F2 | F5 | MTHFR | |-------------------------------------------------------------------------------|----------------|-----|-----|-------| | | Operator 1 | WT | HET | HET | | | WT | HET | HET | | | | Operator 2 | WT | HET | HET | | | WT | HET | HET | | | | Operator 3 | WT | HET | HET | | | WT | HET | HET | | {4}------------------------------------------------ | Study Description | Summary of Results | | | | |------------------------------------------------------------------------|------------------------------------------------------------|-----|----|-------| | One operator analyzed the same sample in duplicate using three lots | 3 Reagent Lots | F2 | F5 | MTHFR | | of reagents. | Lot 1 cartridge: 082107001A buffer: 082207001C | HET | WT | HET | | | Lot 2 cartridge: 082707001C buffer: 050707001D | HET | WT | HET | | | Lot 3 cartridge: 082807001A buffer: 082707001D | HET | WT | HET | ### Additional performance characteristics for Verigene F5 / F2 / MTHFR Nucleic Acid Tests: | Characteristic | Verigene F5 Nucleic Acid Test | Verigene F2 Nucleic Acid Test | Verigene MTHFR Nucleic Acid Test | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Analytical sensitivity (LDL) | 40 ng/µL | 40 ng/µL | 40 ng/µL | | Call rate | 98.3% (282 out of 287 calls made) | 94.7% (272 out of 287 calls made) | 93.4% (268 out of 287 calls made) | | Diagnostic sensitivity specificity | 100% (95%CI=98.9 to 100%) 100% (95%CI=98.9 to 100%) | 100% (95%CI=98.9 to 100%) 100% (95%CI=98.9 to 100%) | 100% (95%CI=98.9 to 100%) 100% (95%CI=98.9 to 100%) | | Precautions and warnings | In the F5 gene, additional rare mutations other than the 1691G>A base change have been observed. Some of these mutations occur in regions covered by the oligonucleotide probes used in the test. The presence of one or more of these mutations may lead to an unknown result. NOTE: none of the mutations listed above have been linked to APC resistance. This test should not be used alone to diagnose thrombophilias. It is recommended that activated protein C (APC) testing be done alongside the genetic test. | In the F2 gene, additional rare mutations other than the 20210G>A base change have been observed. Some of these mutations occur in regions covered by the oligonucleotide probes used in the test. The presence of one or more of these mutations may lead to an unknown result. This test should not be used alone to diagnose thrombophilias. | In the MTHFR gene, additional rare mutations other than the 677C>T base change have been observed. Some of these mutations occur in regions covered by the oligonucleotide probes used in the test. The presence of one or more of these mutations may lead to an unknown result. This test should not be used alone to diagnose thrombophilias. | {5}------------------------------------------------ | Interferences | Performance not affected by magnetic beads heparin hemoglobin 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 HC 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 can be frozen. | . Verigene® is a registered trademark of Nanosphere, Inc. Verigene® is a registered trademark of Nanosphere, Inc. LightCycler® is a registered trademark of Roche Diagnostics Corp. . {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 # MAR 2 4 2009 Nanosphere, Inc. c/o Gregory W. Shipp, M.D. Chief Medical Officer, VP of Medical and Regulatory Affairs and Quality Assurance 4088 Commercial Avenue Northbrook, IL 60062 Re: k070597 Trade/Device Name: Verigene® F5 Nucleic Acid Test Verigene® F2 Nucleic Acid Test Verigene® MTHFR Nucleic Acid Test Verigene® System 21 CFR 864.7280 Regulation Number: 21 CFR 862.2570 Regulation Name: Factor V Leiden DNA mutation detection systems Instrumentation for clinical multiplex test systems Regulatory Class: Class II Product Code: NPQ, NPR, OMM, NSU Dated: October 5, 2007 Received: October 9, 2007 Dear Dr. Gregory Shipp, This letter corrects our substantially equivalent letter of October 11, 2007. 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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {7}------------------------------------------------ Page 2 - Gregory W. Shipp, M.D. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to continue 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0377. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, ia m clar Maria M. Chan, Ph.D Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ #### a. Indications for use 2 510(k) Number (if known): K070597 Device Name: Verigene® System Indications for Use: The Verigene System is a bench-top molecular diagnostics workstation that automates the analysis and detection of nucleic acids using gold nanoparticle probe technology. 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) Coricurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Josephine Bautista Division Sign-off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K 070597 Page 1 of 1 {9}------------------------------------------------ # 2 b. Indications for use 510(k) Number (if known): K070597 ### Device Name: Verigene F5 Nucleic Acld Test Indications for Use: The Verigene F5 Nucleic Acid Test is Indicated as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is an in vitro diagnostic for the detection and genotyping of a single-point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene), from Isolated genomic DNA obtained from whole blood samples. The test is intended to be used on the Verigene System. Prescription Use × (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) Josephine Bartista Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and S 510(k) K070597 Page 1 of 1 {10}------------------------------------------------ # 2 c. Indications for use 510(k) Number (if known): K070597 Device Name: Verlgene F2 Nucleic Acld Test Indications for Use: The Verigene F2 Nucleic Acid Test is indicated as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is an in vitro diagnostic for the detection and genotyping of a single-point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene), from isolated genomic DNA obtained from whole blood samples. 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) Juchim Bantide Division Sign Off Office of In Vitro Diagnostic Device uation and Sa 510(k) k070597 {11}------------------------------------------------ ## 2 d. Indications for use 510(k) Number (if known): K070597 Device Name: Verigene MTHFR Nucleic Acld Test Indications for Use: The Verigene MTHFR Nucleic Acid Test is indicated as an aid to diagnosis in the evaluation of patients with suspected thrombophilia and elevated levels of homocysteine or altered folate metabolism. The test is an in vitro diagnostic for the detection and genotyping of a single-point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR), from isolated genomic DNA obtalned from whole blood samples. The test is intended to be used on the Verigene System. Prescription Use × (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) Josephine Bautista Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safery 510(k) K070597 ### Page 1 of 1