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GenetiSure Dx Postnatal Assay is a qualitative assay intended for the postnatal detection of copy number variations (CNV) and copy-neutral loss of heterozygosity (cnLOH) in genomic DNA obtained from peripheral whole blood in patients referred for chromosomal testing based on clinical presentation. GenetiSure Dx Postnatal Assay is intended for the detection of CNVs and cnLOH associated with developmental delay, intellectual disability, congenital anomalies or dysmorphic features. Assay results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, parental evaluation, clinical genetic evaluation, and counseling, as appropriate. Interpretation of assay results is intended only by healthcare professionals, board certified in clinical cytogenetics. The assay is intended to be used on the SureScan Dx Microarray Scanner System and analyzed by CytoDx Software. This device is not intended to be used for standalone diagnostic purposes, pre-implantation or prenatal testing or screening, population screening, or for the detection of, or screening for, acquired or somatic genetic aberrations.

The GenetiSure Dx Postnatal Assay is a clinical laboratory in vitro diagnostic assay for performing molecular karyotyping based on array comparative genomic hybridization (aCGH) and single nucleotide polymorphism (SNP) analysis from blood samples of post-natal patients who are suspected of having a genomic abnormality. This molecular karyotyping is a modified in situ hybridization technique that allows detection and mapping of DNA sequence copy difference(s) between two genomes in a single experiment. In molecular karyotyping analysis, two differentially labeled genomic DNAs (subject/test sample and a reference sample) are co-hybridized to complementary nucleic acid sequences synthesized in situ on a microarrav slide. Locations of copy number variation (CNVs) and copy-neutral loss of heterozygosity (cnLOH) in the DNA segments of the subject sample genome are revealed by variable fluorescence intensity on the microarray. The assay compares the patient sample against a sex-matched reference sample. Genomic DNA (gDNA) is extracted from the patient's whole blood and then is fluorescently labeled in parallel with the reference sample using two different fluorescent dyes. The two labeled samples are hybridized to complementary sequences (probes) that are printed on a CGH+SNP microarray. After hybridization, the microarrays are washed and then scanned. The data from the microarray images are converted to numeric data. The relative abundance of the target sequences is computed based on the relative intensities of the fluorophores in the patient and reference samples hybridized to each of the probe sequences. The numeric data is then processed using software specifically designed to report CNVs by chromosomal location. The reported CNVs are interpreted by a Board Certified Cytogeneticist, Molecular Geneticist, Molecular Pathologist, or similarly qualified clinician who has been trained to identify the clinically relevant CNVs, determine clinical significance, and report out these findings. cnLOH in patient samples is also reported to the clinician.

The M2376A DeviceLink System is indicated for use in data collection and bedside devices. The M2376A is not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

The M2376A Device Link System receives digital data produced by external devices through device specific cables, converts that data into the HL7 External and transmits that information to any networked Clinical Information System.

TeleMon is indicated for use in the monitoring, recording, and alarming of multiple physiologic parameters in adult and pediatric patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms. TeleMon is a prescription devices for use in healthcare facilities by trained healthcare professionals. TeleMon is not intended for home use.

The Agilent M2636B TeleMon B Monitor is an upgraded version of the current M2636A TeleMon, which is an extension device for the M2600A Telemetry System. The modification in this submission is the addition of audible alarms, the display of pulse and PVC rate numerics, a software upgradeable NBP module with improved measurement time, and the addition WaveViewer functionality to the M2636A TeleMon B Monitor, a multi-parameter monitor as an extension to the M2600A Telemetry System. The new device will be known as the M2636B TeleMon B Monitor.

The M2376A DeviceLink System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. The M2376A is not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

The M2376A Device Link System receives digital data produced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System.