The Verigene System is a bench-top molecular diagnostics workstation that automates the analysis and detection of nucleic acids using gold nanoparticle probe technology.

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.

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.

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.

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). These tests use extracted and purified DNA, mixed with hybridization buffer, loaded into the sample well of the Test Cartridge. 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.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Nanosphere Verigene System and its associated nucleic acid tests, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied through the reported performance for diagnostic sensitivity and specificity, and the call rate. While explicit numerical acceptance criteria for these metrics aren't stated as "acceptance criteria," the reported 100% diagnostic sensitivity and specificity, and the high call rates, indicate successful performance for a device seeking substantial equivalence.

Characteristic	Acceptance Criteria (Implied by context)	Reported Device Performance (F5, F2, MTHFR)
Diagnostic Sensitivity	High (e.g., close to 100%)	100% (95%CI=98.9 to 100%)
Diagnostic Specificity	High (e.g., close to 100%)	100% (95%CI=98.9 to 100%)
Call Rate (Overall)	High	F5: 98.3% (282/287 calls)
		F2: 94.7% (272/287 calls)
		MTHFR: 93.4% (268/287 calls)
Analytical Sensitivity (LDL)	Detectable at relevant concentrations	40 ng/µL
Mis-calls	0%	0% (across all reproducibility studies)

Study Details

Sample sizes used for the test set and the data provenance:
- Reproducibility Study #1:
  - F5: 118 samples (Site 1, Operators A & B), 60 samples (Site 2, Operators C & D), 58 samples (Site 3, Operator E), 59 samples (Site 3, Operator F). Total = 295 samples. (Note: The "Correct Calls (%)" sums slightly differently across operators for F5, F2, MTHFR, so this is derived from the "Total Calls" which is 118 for Site 1, 60 for Site 2, 58 for Operator E Site 3, and 59 for Operator F Site 3. The footnote clarifies that 10 cartridges failed to run, meaning the total tests attempted were higher.)
  - F2: Similar sample numbers as F5 for each site and operator.
  - MTHFR: Similar sample numbers as F5 for each site and operator.
  - Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
- Diagnostic Sensitivity/Specificity & Call Rate: Values are based on a total of 287 calls made (for Call Rate), implying a test set of at least 287 samples when considering successful calls. The specific number of samples for diagnostic sensitivity and specificity calculation is presented with 95% confidence intervals, but the raw count is not provided (e.g., "out of X positive samples" or "out of Y negative samples").
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set. The nature of the device (genotyping) suggests the ground truth would likely be established by a reference genetic test or sequencing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe any adjudication method.
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 MRMC comparative effectiveness study was done. This device is a diagnostic test for genetic mutations, not an imaging device requiring human reader interpretation, nor does it involve AI assistance for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The performance characteristics (reproducibility, analytical sensitivity, call rate, diagnostic sensitivity, diagnostic specificity) are for the Verigene System itself, operating as an automated in vitro diagnostic device. Human operators are involved in sample preparation and loading, but the genotyping analysis and detection are automated by the system.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The document does not explicitly state the method for establishing ground truth, but for genetic tests, the ground truth is typically established by orthogonal genetic testing methods such as DNA sequencing or a clinically validated reference method for detecting the specific gene mutations (e.g., PCR-based assays from a reputable lab). The predicate devices are also nucleic acid test kits, supporting this assumption.
The sample size for the training set:
- The document does not specify a training set or its sample size. This type of device relies on established probe chemistry and detection algorithms based on biophysical principles, rather than machine learning models that require a distinct training phase.
How the ground truth for the training set was established:
- As no training set is described, there's no information on how its ground truth would have been established.

Summary

{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 AvenueNorthbrook, IL 60062Phone: 847-400-9000 Fax: 847-400-9199
Contact:	Sue Kent - Manager, Clinical & Regulatory Affairs
Proprietary names:	For instrument:Verigene® SystemFor the assays:Verigene HC Nucleic Acid TestVerigene F5 / F2 / MTHFR Nucleic Acid TestVerigene F5 / F2 Nucleic Acid TestVerigene F2 Nucleic Acid TestVerigene F5 Nucleic Acid TestVerigene MTHFR Nucleic Acid Test
Common names:	For the instrument:Bench-top molecular diagnostics workstationFor the assays:F2, FII, Factor II, coagulation factor II, prothrombinF5, FV, Factor V, coagulation factor VMTHFR, methylenetetrahydrofolate reductaseHypercoagulation panelHC panel
Device descriptions:	The Verigene System is an in vitro diagnostic device for processing andgenotyping multiple genes in a DNA sample. The Verigene System consists oftwo instruments, the Verigene Processor and the Verigene Reader, and utilizessingle-use, disposable Test Cartridges to process and genotype multiple genes ina DNA sample in approximately 1½ hours.Clinicians use one or more of the three genes ( F5, F2, MTHFR ) and theirassociated single nucleotide polymorphisms (SNPs) to help diagnose patients'hereditary contributory factors in forming blood clots (thrombi). On the VerigeneSystem, hypercoagulation testing can include one or more of three genotypesthat 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
Enzymaticmanipulation of sample	No(chemical amplification ofreporter signal)	Yes(DNA amplification viaPCR)
Detection procedure	Single-image sensorwhere nanoparticles areilluminated using a fixed-wavelength light source	Optical detection ofstimulated fluorescence
Heating method	1) Sonication horn forsample denaturation2) Temperature-controlled heat block incontact with substrate	Hot air cycling with glasscapillaries
Detection chemistry	SNP discrimination viaoligonucleotide probes;detection via evanescentwave light scatter withnanoparticles	Paired hybridizationprobes usingfluorescence resonanceenergy transfer (FRET)
Primary operationalcomponents	Integrated hybridization/washing forwalkaway assayhybridization anddetection.Automated array imageacquisition and resultsinterpretation.	Integrated thermocyclerand microvolumefluorimeter for walkawayPCR amplification anddetection.
Specimen type	Purified nucleic acids	Purified nucleic acids
Specimen preparation	DNA isolation performedoff-line. Fragmentation ofDNA performedonboard.	Performed off line
Sample positions	4 – 32	32
Sample size	25 μl	10-20 μL in glasscapillaries
Number of opticaldetection channels	One fixed-wavelengthimager	Three with fixedwavelengths (530 nm,640 nm, 710 nm)
Analysis Time	2 minutes	Detection occurs atdefined intervals duringPCR cycle and can beviewed in real-time
User interface	Embedded softwarein closed system,integrated graphical user	PC with instrument-specific software(LightCycler version 3.5or 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 (%)
Operator A	1	117 (99.2%)*	1 (0.8%)
Operator B	1	114 (99.1%)*	1 (0.9%)
Operator C	2	59 (98.3%)	1 (1.7%)
Operator D	2	59 (98.3%)	1 (1.7%)
Operator E	3	58 (100.0%)*	0 (0.0%)
Operator F	3	57 (96.6%)*	2 (3.4%)

{3}------------------------------------------------

F2	Site	Correct Calls (%)	No Calls (%)
Operator A	1	117 (99.2%)*	1 (0.8%)
Operator B	1	114 (99.1%)*	1 (0.9%)
Operator C	2	58 (96.7%)	2 (3.3%)
Operator D	2	59 (98.3%)	1 (1.7%)
Operator E	3	58 (100.0%)*	0 (0.0%)
Operator F	3	55 (93.2%)*	4 (6.8%)

MTHFR	Site	Correct Calls (%)	No Calls (%)
Operator A	1	117 (99.2%)*	1 (0.8%)
Operator B	1	113 (98.3%)*	2 (1.7%)
Operator C	2	58 (96.7%)	2 (3.3%)
Operator D	2	58 (96.7%)	2 (3.3%)
Operator E	3	58 (100.0%)*	0 (0.0%)
Operator F	3	56 (94.9%)*	3 (5.1%)

*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

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

3Operators	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 samesample in duplicate using three lots	3 ReagentLots	F2	F5	MTHFR
of reagents.	Lot 1cartridge:082107001Abuffer:082207001C	HET	WT	HET
	Lot 2cartridge:082707001Cbuffer:050707001D	HET	WT	HET
	Lot 3cartridge:082807001Abuffer:082707001D	HET	WT	HET

Additional performance characteristics for Verigene F5 / F2 / MTHFR Nucleic Acid Tests:

Characteristic	Verigene F5 NucleicAcid Test	Verigene F2 NucleicAcid Test	Verigene MTHFRNucleic 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 sensitivityspecificity	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 andwarnings	In the F5 gene,additional rare mutationsother than the 1691G>Abase change have beenobserved. Some ofthese mutations occur inregions covered by theoligonucleotide probesused in the test. Thepresence of one or moreof these mutations maylead to an unknownresult. NOTE: none ofthe mutations listedabove have been linkedto APC resistance.This test should not beused alone to diagnosethrombophilias. It isrecommended thatactivated protein C(APC) testing be donealongside the genetictest.	In the F2 gene,additional raremutations other than the20210G>A base changehave been observed.Some of thesemutations occur inregions covered by theoligonucleotide probesused in the test. Thepresence of one or moreof these mutations maylead to an unknownresult.This test should not beused alone to diagnosethrombophilias.	In the MTHFR gene,additional rare mutationsother than the 677C>Tbase change have beenobserved. Some ofthese mutations occur inregions covered by theoligonucleotide probesused in the test. Thepresence of one or moreof these mutations maylead to an unknownresult.This test should not beused alone to diagnosethrombophilias.

{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

Regulation Number and Section

§ 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.