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The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is a qualitative in vitro diagnostic device intended for use in the detection and genotyping of a single point mutation (G1691A, referred to as the Factor V Leiden mutation or FVL) of the Factor V gene, located on Chromosome 1q23, and a single point mutation (G20210A) of the prothrombin gene (referred to as Factor II or FII), located on Chromosome 11p11-q12, from genomic DNA isolated from EDTA anti- coagulated human whole blood samples. The test is to be performed on the IMPACT Dx System and is indicated for use as an aid in the diagnosis of patients with suspected thrombophilia.

The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is a qualitative, multiplexed genetic testing device for parallel detection and genotyping of the point mutations G1691A of the Factor V gene and G20210A of the Factor II gene from genomic DNA isolated from EDTA anti- coagulated human whole blood samples. The test is to be performed on the IMPACT Dx System. The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is performed using the IMPACT Dx System, which includes the IMPACT Dx NANO and the IMPACT Dx MA, a matrix-assisted laser desorption / ionization time-of-flight (MALDI-TOF) mass spectrometer. The test involves Factor V and Factor II region-specific polymerase chain reaction (PCR) amplification of genomic DNA purified from human whole blood in a multiplexed reaction, followed by allele-specific single base primer extension reactions. The reaction products are desalted, dispensed onto a SpectroCHIP® Array using the IMPACT Dx NANO, and the genotyping products are resolved on the basis of mass using the IMPACT Dx MA. The IMPACT Dx Factor V Leiden and Factor II Genotyping Test provides reagents for multiplex PCR, deoxynucleotide triphosphate dephosphorylation, and single base extension. The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is comprised of the following components: - IMPACT Dx Factor V Leiden and Factor II Primer Set - IMPACT Dx PCR Reagent Set - IMPACT Dx Extend Reagent Set The IMPACT Dx Factor V Leiden and Factor II Genotyping Test utilizes a biochemistry process (Sequenom Biochemistry) that involves target-specific PCR amplification and single-base extension reactions with the subsequent analysis of the reaction products of the target nucleic acids by matrixassisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS), The IMPACT Dx System (System) is a platform for highly accurate and sensitive genomic analysis and is designed for use with FDA cleared or approved assays citing its use. The IMPACT Dx System is comprised of the following instruments, software and consumables; - IMPACT Dx NANO (NANO) - IMPACT Dx MA (MA) - TYPER Dx Software (TYPER Dx) - System Consumables - SpectroCHIP® Arrays (Chip) - Clean Resin - 3-Point Calibrant (Calibrant) The System is intended to be used by trained operators in a professional laboratory to perform the following key tasks: - De-salt (using Clean Resin) amplified nucleic acid samples, upon completion of polymerase chain reaction (PCR) and single-base extension reactions following the instructions provided in the Sequenom test-specific package insert; - Transfer (using the IMPACT Dx NANO) de-salted nucleic acid samples from a microtiter plate onto a disposable 96-pad sample Chip; - Obtain mass spectra (using the IMPACT Dx MA) from samples and 3-Point Calibrant on a Chip; and - Analyze (using the TYPER Dx software) the mass spectra of the samples for genotyping results. The IMPACT Dx System accomplishes genomic analysis and genotyping testing by coupling a biochemistry process (Sequenom biochemistry) that involves target-specific PCR amplification and single-base extension reactions with the subsequent analysis of the reaction products of the target nucleic acids by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS). This biochemistry process is homogeneous and does not require purification of the PCR products or the extension products and thus is very amenable to high-throughput genotyping testing. The IMPACT Dx NANO is a self-contained, enclosed instrument that uses computer-controlled robotics to transfer nanoliter volumes of analyte from a 96-well microtiter plate onto a Chip, which is subsequently processed by means of MALDI-TOF MS analysis on the IMPACT Dx MA. This instrument includes an integrated computer pre-loaded with the Nanodispenser software and provides a simple touch-screen interface for users. The IMPACT Dx MA is a bench top mass spectrometer that processes analyte-loaded Chips by means of MALDI-TOF MS analysis. This instrument includes an integrated computer pre-loaded with the TYPER Dx software, a monitor, and a firewall for secure communication with the IMPACT Dx NANO. The main function of the IMPACT Dx MA is to acquire mass spectra from analytes that have been transferred onto a Chip, which has a chemical matrix on each pad. The mass spectra are captured and further analyzed by the TYPER Dx software. The TYPER Dx software (TYPER Dx) manages the processing of Sequenom genotyping tests. It is deployed on the computer embedded within the IMPACT Dx MA. The TYPER Dx software provides the following key functions: - Allows users to create and manage panel runs; - Monitors analyte transfer activities on the IMPACT Dx NANO; - Controls user-initiated, automated mass spectrum acquisition runs on the IMPACT Dx MA; - Analyzes the mass spectra acquired by the IMPACT Dx MA and makes genotype calls per a test-specific algorithm; - Enables users to view and export results; and - Allows an administrator to manage users to ensure secure access to the IMPACT Dx MA and panel run data.