(223 days)
Not Found
No
The device description focuses on molecular diagnostics using gold nanoparticle probe technology and a photosensor for signal reading. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Automated array image acquisition and results interpretation" is a common feature in many non-AI/ML based diagnostic systems and does not inherently indicate the use of AI/ML.
No
Explanation: This device is an in vitro diagnostic (IVD) system used to aid in the diagnosis of thrombophilia by detecting specific genetic mutations. It provides information for diagnosis rather than directly treating or preventing a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the various nucleic acid tests (F5, F2, MTHFR) performed by the Verigene System are "Indicated as an aid to diagnosis" and are "in vitro diagnostic" devices. The "Device Description" also refers to the system as an "in vitro diagnostic device."
No
The device description explicitly states the system consists of two instruments (Verigene Processor and Verigene Reader) and utilizes single-use, disposable Test Cartridges, indicating significant hardware components are involved.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated: The "Intended Use / Indications for Use" section clearly states for each test (Verigene F5, F2, and MTHFR Nucleic Acid Tests) that it is an "in vitro diagnostic".
- Definition of IVD: An in vitro diagnostic device is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. This device analyzes isolated genomic DNA from whole blood samples to detect specific genetic mutations associated with thrombophilia, which aligns perfectly with the definition of an IVD.
- Purpose: The tests are indicated as an "aid to diagnosis" in the evaluation of patients with suspected thrombophilia, which is a diagnostic purpose.
- Sample Type: The device uses isolated genomic DNA obtained from whole blood samples, which are biological samples tested in vitro (outside the body).
- Testing Method: The device performs molecular diagnostics by analyzing nucleic acids using gold nanoparticle probe technology, a common method for in vitro testing.
- Device Description: The "Device Description" also refers to the Verigene System as an "in vitro diagnostic device".
Therefore, based on the provided text, the Verigene System and its associated tests are clearly identified and function as In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Verigene System is a bench-top molecular diagnostics workstation that 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.
Product codes (comma separated list FDA assigned to the subject device)
NPQ, NPR, OMM, 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.
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).
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: 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: Operator A (Site 1) - 117 (99.2%) Correct Calls; Operator B (Site 1) - 114 (99.1%) Correct Calls; Operator C (Site 2) - 59 (98.3%) Correct Calls; Operator D (Site 2) - 59 (98.3%) Correct Calls; Operator E (Site 3) - 58 (100.0%) Correct Calls; Operator F (Site 3) - 57 (96.6%) Correct Calls.
F2: Operator A (Site 1) - 117 (99.2%) Correct Calls; Operator B (Site 1) - 114 (99.1%) Correct Calls; Operator C (Site 2) - 58 (96.7%) Correct Calls; Operator D (Site 2) - 59 (98.3%) Correct Calls; Operator E (Site 3) - 58 (100.0%) Correct Calls; Operator F (Site 3) - 55 (93.2%) Correct Calls.
MTHFR: Operator A (Site 1) - 117 (99.2%) Correct Calls; Operator B (Site 1) - 113 (98.3%) Correct Calls; Operator C (Site 2) - 58 (96.7%) Correct Calls; Operator D (Site 2) - 58 (96.7%) Correct Calls; Operator E (Site 3) - 58 (100.0%) Correct Calls; Operator F (Site 3) - 56 (94.9%) Correct Calls.
Reproducibility Study #2: Included 4 studies, each using a different A Subsequent reprodublity tooling invidued + oration varators at 3 sites.
Study 1 (3 Sites): Each of the three test sites ran the same sample in duplicate. Results for F5, F2, MTHFR per site are listed as HET or WT calls for each duplicate run across 3 sites.
Study 2 (3 Days): One operator analyzed the same sample in duplicate each day for three days. Results for F2, F5, MTHFR per day are listed as WT or HET calls for each duplicate run across 3 days.
Study 3 (3 Operators): Three operators at one site each analyzed the same sample in duplicate. Results for F2, F5, MTHFR per operator are listed as WT or HET calls for each duplicate run across 3 operators.
Study 4 (3 Reagent Lots): One operator analyzed the same sample in duplicate using three lots of reagents. Results for F2, F5, MTHFR per lot are listed as HET or WT for each duplicate run across 3 reagent lots.
Additional performance characteristics:
Analytical sensitivity (LDL): 40 ng/µL for F5, F2, MTHFR.
Call rate: 98.3% for F5 (282 out of 287); 94.7% for F2 (272 out of 287); 93.4% for MTHFR (268 out of 287).
Diagnostic sensitivity/specificity: 100% (95% CI = 98.9 to 100%) for sensitivity and specificity for F5, F2, and MTHFR.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical sensitivity (LDL): 40 ng/µL for F5, F2, MTHFR.
Call rate: 98.3% (282 out of 287 calls made) for Verigene F5 Nucleic Acid Test; 94.7% (272 out of 287 calls made) for Verigene F2 Nucleic Acid Test; 93.4% (268 out of 287 calls made) for Verigene MTHFR Nucleic Acid Test.
Diagnostic sensitivity: 100% (95%CI=98.9 to 100%) for Verigene F5, F2, and MTHFR Nucleic Acid Tests.
Diagnostic specificity: 100% (95%CI=98.9 to 100%) for Verigene F5, F2, and MTHFR Nucleic Acid Tests.
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
§ 862.2570 Instrumentation for clinical multiplex test systems.
(a)
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.(b)
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.
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 |
- 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