The INFINITI™ System Assay for Factor II & Factor V is an in vitro diagnostic device that consists of reagents and instrumentation which includes polymerase chain reaction (PCR) primers, hybridization matrices, a thermal cycler, an imager, and software for detection and genotyping of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A point mutations in DNA obtained from human blood samples. The INFINITI™ System Assay for Factor II & Factor V is a qualitative assay for use in clinical laboratories upon prescription by the attending physician.

The INFINITI" System Assay for detection and genotyping of Factor II & Factor V is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

Device Description

The INFINITI System Assay for Factor II & Factor V is an in vitro diagnostic device which utilizes proprietary film-based microarray technology combined with process automation, reagent management and software technology for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation from deoxyribonucleic acid (DNA) isolated from human whole peripheral blood samples.

The INFINITI System Assay for Factor II & Factor V is comprised of the BioFilmChip" Microarray, the Intellipac™ Reagent Module, and the INFINITI Analyzer with the Qmatic" Operating Software.

The BioFilmChip Microarray consists of a polyester film coated with proprietary multi-layer components designed for DNA analysis. The layers have been designed to provide a versatile surface to enhance test performance. There can be up to 240 spots per microarray with each spot representing a different allele. The microarrays are designed to be assay specific.

The Intellipac Reagent Module which acts as a communication link contains up to eight reservoirs that house the test reagents and has an integrated memory chip. The assay protocol resides in this memory chip and upon request is loaded to the INFINITI Analyzer. Information such as expiration date of reagents, volume usage, time of use and operation parameters are archived in the memory chip and appear on the worklist (run report).

The INFINITI Analyzer is an instrument used for clinical multiplex systems intended to measure and sort multiple signals from a clinical sample. The INFINITI Analyzer is designed to measure fluorescence signals of labeled DNA target hybridized to BioFilmChip microarrays. The INFINITI Analyzer automates the Factor II and Factor V assays and integrates all the discrete processes of sample (PCR amplicon) handling, reagent management, hybridization, detection, and results analysis. The assays are processed automatically and read by the built-in confocal microscope. Results are analyzed and presented in numerical and graphical format.

The INFINITI Analyzer has two main components: pipetting and optics modules. A variety of electronic components inside the instrument are used for its operation. These include multiple stepper motors, heating and cooling devices, a barcode reader, a photomultiplier tube, and a camera all connected to USB ports.

Pipetting Module - The pipetting module performs all the operations related to dispensing and aspiration of reagent and processing the amplified sample to be dispensed on the microarray. When the sample has been processed and hybridized to the microarray, it is transferred to the optics module for scanning and reading.

Optics Module - The optics module is a lightproof assembly comprised of a 3-axis stage: camera, lasers, and a photo multiplier tube (PMT). It is the enclosed casement into which the microarray is transported automatically prior to being processed on the stringency station. The optics' stage follows X-Y-Z motions that can be stepped at a very precise rate (2.0 micron per step). Using excitation wavelengths of a 760nm laser diode, the camera takes a 1.2x1.2mm picture for each registration spot of a fluorescent die. Analyses of these pictures allow the location of three registration spots to be determined. With respect to the position of the three registration spots, coordinates of all the bio-spots can be located. While scanning, the stage moves along the Z-axis to focus the chip and the X and Y-axes to locate the individual spots on the microarray.

The INFINITI Analyzer hardware is controlled by the Qmatic™ operating software, which is installed with-in the on-board computer and utilizes a LCD screen display. The INFINITI Analyzer modules are controlled by multitasking real time software. The Omatic "M operating software has a schedule manager that is capable of controlling all operations of the INFINITI Analyzer such as assay protocol, fluid handling, robotics, optical detection and result analysis. Results are available for review via the LCD screen. Management reports include results in numerical and graphical format. The operator can also print the displayed results in tabular form (printer not included with INFINITI Analyzer).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the INFINITI™ System Assay for Factor II & Factor V, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary largely focuses on demonstrating equivalence to predicate devices and detailing performance characteristics rather than explicitly stating pre-defined "acceptance criteria" with specific thresholds for all metrics. However, we can infer the implied acceptance based on the reported results and the comparison to the predicate device.

Feature	Acceptance Criteria (Inferred from Predicate Equivalence/Performance)	Reported Device Performance and Remarks
Percent Agreement with Predicate	- Factor II: >95% agreement with predicate device (Roche Factor II G20210A Kit) - Factor V: >95% agreement with predicate device (Roche Factor V Leiden Kit)	- Factor II: 98.6% agreement with predicate - Factor V: 100.0% agreement with predicate
Limit of Detection (LoD)	Sufficient to detect mutations in typical clinical samples.	1ng DNA/test.
Assay Precision/Reproducibility	- Chip-to-chip: Low CVs for wild-type calls, 100% correct genotype calls. - Lot-to-lot: No significant lot-to-lot difference (p>0.05) in RFU, 100% correct genotype calls. - Day-to-day: Acceptable RFU signal %CV, 100% correct genotype calls.	- Chip-to-chip: CVs for wild-type present calls ranged from 9-12%. All calls were 100% correct. - Lot-to-lot: Two-way ANOVA on RFU readings did not detect lot-to-lot difference on three of four test runs (p > 0.05). Detected lot-to-lot difference on one test run (0.05 > p > 0.01). Genotype calls were 100% correct. - Day-to-day: RFU signal %CV ranged from 1.35-14.87 (Day 1), 0.77-19.72 (Day 2), and 0.41-21.2 (Day 3). Genotype calls were 100% correct.
Instrument Reproducibility	- Intra-Instrument: Acceptable %CV, 100% genotype call reproduction. - Inter-Instrument: Acceptable %CV, 100% correct and reproducible genotype calls.	- Intra-Instrument Reproducibility: %CV using a single chip five times on a single instrument ranged from 0.9 to 28.3%. Genotype calls were 100% reproduced within each instrument. - Inter-Instrument Reproducibility: %CV using a single chip five times on each of three instruments ranged from 0.5% to 12%. All genotype calls were 100% correct and reproducible. - Standard Microarray Chip: For three instruments, average %CV for capture probe spots ranged from 3.24% to 4.03%, with ranges per instrument from 1.9-7.5%.
Reagent Stability	Demonstrated stability for adequate shelf life.	- BioFilmChip Microarray: 90 days at RT (25-30 °C) - Intellipac Reagent Module: 90 days at 4°C - Amplification Mix: 90 days at 4°C
Interference	No significant interference from common interferents.	No interference with 8mg/dL bilirubin, 70mg/dL cholesterol, and 1333μ/dL heparin. No studies conducted with oral anti-coagulants (no claims made).
Sample Carry-over	No detectable carry-over.	No carry-over detected when a series of positive and negative samples, followed by a "No Template Control," was run six times.

2. Sample Sizes Used for the Test Set and Data Provenance

The "test set" here refers to the samples used for the comparative effectiveness study against the predicate device.

Factor II G20210A mutation: 208 samples
Factor V Leiden G1691A mutation: 175 samples

The document does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the given 510(k) summary. The ground truth for the comparison study was based on the results from the predicate devices (Roche Factor II G20210A and Factor V Leiden Kits). It's implied that the predicate devices themselves established the "ground truth" for the samples.

4. Adjudication Method for the Test Set

This information is not provided. The comparison was directly between the new device and the predicate device results. There's no mention of an independent adjudication process for discrepancies.

5. 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

Not Applicable. This device is an in-vitro diagnostic (IVD) assay system and analyzer, not an AI-powered image analysis or diagnostic aid for human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance is not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance characteristics described, such as Limit of Detection, Assay Precision, Instrument Reproducibility, Reagent Stability, Interference, and Sample Carry-over, represent the standalone performance of the INFINITI™ System Assay for Factor II & Factor V. The comparison to the predicate device also assesses its standalone diagnostic performance.

7. The Type of Ground Truth Used

The ground truth for the comparative effectiveness study was established by the predicate devices: the Roche Factor II G20210A Kit and the Roche Factor V Leiden Kit. This means the device's accuracy was assessed by its agreement with these established, FDA-cleared methods.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" size. As this is a molecular diagnostic assay system, the development process typically involves optimizing reagents and conditions rather than training a machine learning algorithm in the conventional sense. The "training" would be more akin to assay development and validation using various known samples.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" for a machine learning algorithm is not explicitly defined or used in the context of this traditional IVD assay, the method for establishing its ground truth is not applicable in the same way. The development of the assay would have relied on known positive and negative controls, synthetic DNA, and clinical samples with previously determined genotypes (likely via Sanger sequencing or other established reference methods during the predicate device's development or the assay's R&D phase). This type of information is generally part of the assay development and validation process rather than a separate "training set" section in a 510(k) summary.

Summary

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K060564

FEB 7 2007

510(k) Summary

....

The following information is being provided in accordance with the requirements of 21 CFR 807.92

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510(k) SUMMARY

Submitted By	AutoGenomics, Inc.2251 Rutherford RoadCarlsbad, CA 92008, USATelephone: (760) 804-7378FAX: (760) 804-7382
	Contact Person: Evelyn LopezDirector of Regulatory Affairs
	Date Prepared: January 10, 2007
Device Name	Trade or Proprietary Name: INFINITI™ System Assay forFactor II & Factor V
	Common or Usual Name: Factor II (Prothrombin) G20210Gand Factor V Leiden G1691A Mutation Detection System
	Classification Name: 21 CFR 864.7280 Factor V Leiden DNAmutation detection systems
Predicate Device	Roche Factor V Leiden KitRoche Factor II (Prothrombin) G20210AAffymetrix GeneChip® Microarray Instrumentation System
Device Description	The INFINITI System Assay for Factor II & Factor V is an in vitrodiagnostic device which utilizes proprietary film-based microarraytechnology combined with process automation, reagentmanagement and software technology for the detection andgenotyping of the Factor II (Prothrombin) G20210A mutation andthe Factor V Leiden G1691A mutation from deoxyribonucleic acid(DNA) isolated from human whole peripheral blood samples.
	The INFINITI System Assay for Factor II & Factor V is comprisedof the BioFilmChip" Microarray, the Intellipac™ Reagent Module,and the INFINITI Analyzer with the Qmatic" Operating Software.
	The BioFilmChip Microarray consists of a polyester film coatedwith proprietary multi-layer components designed for DNAanalysis. The layers have been designed to provide a versatilesurface to enhance test performance. There can be up to 240 spots

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per microarray with each spot representing a different allele. The microarrays are designed to be assay specific.

. Pipetting Module - The pipetting module performs all the operations related to dispensing and aspiration of reagent and processing the amplified sample to be dispensed on the microarray. When the sample has been processed and hybridized to the microarray, it is transferred to the optics module for scanning and reading.
. Optics Module - The optics module is a lightproof assembly comprised of a 3-axis stage: camera, lasers, and a photo multiplier tube (PMT). It is the enclosed casement into which the microarray is transported automatically prior to being processed on the stringency station. The optics' stage follows X-Y-Z motions that can be stepped at a very precise rate (2.0 micron per step). Using excitation wavelengths of a 760nm laser diode, the camera takes a 1.2x1.2mm picture for each registration spot of a fluorescent die. Analyses of these pictures allow the

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location of three registration spots to be determined. With respect to the position of the three registration spots, coordinates of all the bio-spots can be located. While scanning, the stage moves along the Z-axis to focus the chip and the X and Y-axes to locate the individual spots on the microarray.

Intended Use The INFINITI System Assay for Factor II & Factor V is an in vitro diagnostic device that consists of reagents and instrumentation which includes polymerase chain reaction (PCR) primers, hybridization matrices, a thermal cycler, an imager, and software for detection and genotyping of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A point mutations in DNA obtained from human blood samples. The INFINITI System Assay for Factor II & Factor V is a qualitative assay for use in clinical laboratories upon prescription by the attending physician.

Indication for Use The INFINITI System Assay for detection and genotyping of Factor II & Factor V is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Substantial Comparison studies indicate that the INFINITI System Assay for Equivalence Factor II & Factor V gives equivalent results to the FDA cleared Roche Factor II G20210A and Factor V Leiden Kits. 98.6% agreement between the two methods was observed when 208 samples were tested for the Factor II G20210A mutation. 100% agreement between the two methods was observed when 175 samples were tested for the Factor V Leiden G1691A mutation.

The INFINITI System Assay for Factor II & Factor V and the Roche Factor II and Roche Factor V Kits are based on the same principle: isolation of DNA from human blood sample, PCR amplification of the purified DNA, hybridization of the amplified

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product, staining of the bound product, and signal detection using fluorescence. The INFINITI System Assay for Factor II & Factor V is a multiplex assay which detects Factor II and Factor V mutations simultaneously while the Roche Factor II and Factor V Kits are separate assays detecting each gene mutation.
Instrumentation used in the INFINITI System Assay for Factor II & Factor V is the INFINITI Analyzer which is similar in design and principle to the FDA cleared Affymetrix GeneChip® Microarray Instrumentation System. Both are multiplex systems designed to measure fluorescence signals of labeled targets hybridized to microarrays and perform hybridization, washing, scanning, and data analysis of microarray chips.
Instrument reproducibility data for the INFINITI Analyzer is comparable to those reported in the 510(k) Summary of the Affymetrix GeneChip Microarray Instrumentation System. See Performance Characteristics for the Reproducibility data for three INFINITI Analyzers tested using a standard microarray chip.
Performance Characteristics	The following are performance characteristics of the INFINITI System Assay for Factor II & Factor V:

Feature	Performance
Limit of Detection	1ng DNA/test
AssayPrecision/Reproducibility	Chip-to-chip: Using the same sample and the same instrument, theassay was run using three chips from one lot of BioFilmChips fivetimes. This was repeated two other times, each time using a differentinstrument. The CVs using average triplicate spots for each mutationranged from 9 – 12% for wild-type present calls. All calls were 100%correct.
	Lot-to-lot: Three lots of BioFilmChip microarray were tested using thesame instrument four times, each time using a different sample. Two-way ANOVA on the RFU readings did not detect lot-to-lot differenceon three of the four test runs (p > 0.05), and detected lot-to-lotdifference on one test run (0.05 > p > 0.01). Genotype calls were100% correct.
	Day-to-day: Known genomic sample was assayed 12 times on each ofthree days using one instrument. The RFU signal %CV ranged from1.35 to 14.87 on day1, 0.77 to 19.72 on day 2 and 0.41 to 21.2 on day

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	3. Genotype calls were 100% correct.
Percent Agreement	(Based on Comparison studies between the INFINITI System Assayfor Factor II & Factor V and the predicate (Roche Factor II and FactorV Kits)98.6% for Factor II as compared with predicate100.0% for Factor V as compared with predicate
InstrumentReproducibility	(see below*)
Reagent Stability	BioFilmChip Microarray: 90 days at RT (25-30 °C)Intellipac Reagent Module: 90 days at 4°CAmplification Mix: 90 days at 4°C
Interference	Results of the interference studies demonstrate that there is nointerference with the INFINITI System Assay for Factor II & Factor Vfrom 8mg/dL bilirubin, 70mg/dL cholesterol, and 1333v/dL heparin.No studies were conducted with oral anti-coagulants; therefore, noclaims are made.
Sample Carry-over	No carry-over was detected when a series of 300ng of a wild typesample (FV-WT; FII-WT) was followed by 10ng of a positive sample(FV-WT; FII-M), followed by 300ng of a heterozygous sample (FV-H;FII-H), followed by a "No Template Control" or water, was run sixtimes.

*Instrument Reproducibility

. One DNA sample was analyzed using three different INFINITI Analyzers and one lot of BioFilmChips, five times (five runs).
Intra-Instrument Reproducibility: The %CV using a single chip five times on a single instrument ranged from 0.9 to 28.3%CV. Genotype calls were 100% reproduced within each instrument

Inter-Instrument Reproducibility: The %CV using a single chip five times on each of three instruments ranged from 0.5% to 12%CV. All genotype calls were 100% correct and reproducible.

. Three instruments were tested on three different days using a Standard (nonassay) Microarray Chip. For each instrument tested, each capture probe spot on

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the Standard Microarray Chip was read 24 times, then averaged, and a %CV calculated for the spot. The following lists the ranges for the %CV for the three instruments tested.

...

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1 - Instruments - I - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
	4.03%	2.7-6.5%
	3.99%	1.9-5.3%
	3.24%	1.9-7.5%

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Image /page/7/Picture/13 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter.

AUTOGENOMICS, INC. C/O Evelyn Lopez 2251 Rutherford Road Carlsbad, California 92008

MAY - 1 2007

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: K060564

Trade/Device Name: INFINITI System Assay for Factor II & Factor V Regulation Number: 21 CFR 864.7280 Regulation Name: Factor V Leiden DNA Mutation Detection System Regulatory Class: Class II Product Code: NPR, NPQ, NSU Dated: March 2, 2006 Received: March 3, 2006

Dear Ms. Lopez:

This letter corrects our substantially equivalent letter of February 7, 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 application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in 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.

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 (QS) 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 begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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Page 2 –

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. 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/industry/support/index.html

Sincerely yours,

Robert Beckerh

Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K060564

Device Name:

INFINITI™ System Assay for Factor II & Factor V

Indications for Use:

The INFINITI" System Assay for detection and genotyping of Factor II & Factor V is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Division Sign-Off
	Concurrence of CDRH, Office of Device Evaluation (ODE)

Office of In Vitro Diagnostic Device Evaluation and Safety

0(k)__________________________________________________________________________________________________________________________________________________________________________

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Regulation Number and Section

§ 864.7280 Factor V Leiden DNA mutation detection systems.

(a)
Identification. Factor V Leiden deoxyribonucleic acid (DNA) mutation detection systems are devices that consist of different reagents and instruments which include polymerase chain reaction (PCR) primers, hybridization matrices, thermal cyclers, imagers, and software packages. The detection of the Factor V Leiden mutation aids in the diagnosis of patients with suspected thrombophilia.(b)
Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection Systems.” (See § 864.1(d) for the availability of this guidance document.)