(132 days)
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No
The summary describes a FISH probe panel and its performance in detecting chromosomal abnormalities. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis relies on standard cytogenetic techniques and signal enumeration.
No
The device is an in vitro diagnostic device used for identifying and enumerating chromosomes to aid in the diagnosis of aneuploidies; it does not provide any therapeutic treatment.
Yes
The device is intended to identify and enumerate chromosomes 13, 18, 21, X, and Y in amniotic fluid, serving as an adjunct to standard cytogenetic analysis for identifying presumed high-risk pregnancies, which directly contributes to diagnosis.
No
The device description clearly states it is a "combination of two DNA probe mixtures" which are physical components used in a laboratory process (FISH). This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "detect alpha satellite sequences... and detect the 13q14 region and the 21q22.13 to 21q22.2 region" in "amniotic fluid in subjects with presumed high risk pregnancies." This involves testing a specimen (amniotic fluid) from the human body to obtain information about a patient's health status (identifying and enumerating chromosomes 13, 18, 21, X, and Y).
- Device Description: The device is a "combination of two DNA probe mixtures" used for "fluorescence in situ hybridization (FISH)." These are reagents and materials used in a laboratory setting to perform a diagnostic test.
- Performance Studies: The document describes a "multi-center, blinded, controlled, comparative study" to evaluate the performance of the device in relation to standard cytogenetic analysis. This type of study is typical for validating the clinical performance of an IVD.
- Key Metrics: The document provides metrics like Analytical Sensitivity, Analytical Specificity, and Reproducibility, which are standard performance characteristics evaluated for IVDs.
- Intended User / Care Setting: The device is intended for use in "Cytogenetics laboratories," which are clinical laboratory settings where diagnostic tests are performed.
While the device is intended to be used as an adjunct to standard cytogenetic analysis and not as a standalone assay, its function is to provide diagnostic information from a human specimen, which falls squarely under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AneuVysion™ (CEP 18, X, Y-alpha satellite, LSI 13 and 21) Multicolor Probe Panel is intended to use CEP 18/X/X probe to detect alpha satellite sequences in the centromere regions of chromosomes 18, X, and Y, and LSI 13/21 probe to detect the 13q14 region and the 21q22.13 to 21q22.2 region. The AneuVysion™ kit is indicated for use as an adjunct to standard cytogenetic metaphase analysis for identifying and enumerating chromosomes 13, 18, 21, X, and Y via fluorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei obtained from uncultured amniotic fluid in subjects with presumed high risk pregnancies. It is not intended to be used as a stand alone grossy for test reporting. FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently utilizing the same patient specimen. FISH results should not be reported prior to standard cytogenetic results except in instances where reporting of FISH results alone is medically indicated or standard cycogenetic results are not available, e.g., culture failure. Reporting and interpretation of FISH should be consistent with professional standards of propotice [1] ] This device is intended for use only with amniocyte cells; it is not intended for and has not been validated for use with other test matrices. This FISH assay will not dee the presence of structural chromosome abnormalities frequently associated with birth defects. This FISH assay will be performed in cytogenetics laboratories.
Product codes (comma separated list FDA assigned to the subject device)
OYU, KIR
Device Description
The AneuVysion™ kit is a combination of two DNA probe mixtures; CEP 18/X/Y and LSI 13/21. The CEP 18/X/Y probe is a mixture of directly labeled fluorescent DNA probes specific for the D18Z1, DXZ1 and DYZ3 regions of chromosomes 18, X, and Y respectively. The LSI 13/21 probe contains a mixture of unique DNA sequences that hybridize in the 13q14 region of chromosome 13, and unique DNA sequences complementary to the D21S259, D21S341, and D21S342 loci contained within the 21q22.13 to 21q22.2 region on the long arm of chromosome 21. The LSI 13 probe was created from a set of overlapping clones which contain the entire RB-1 gene as well as regions extending beyond the gene on both sides. The probe extends beyond the 180 kb RB-1 gene for 110-170 kb in the 5' direction and approximately 120 kb in the 3' direction; the entire probe is 410-470 kb. CEP 18/X/Y is an aqua, green, and orange tri-color probe mixture and LSI 13/21 is a green and orange dual-color probe mixture. The Aneu Vysion™ (CEP 18, X, Y-alpha satellite, LSI 13 and 21) Multicolor Probe Panel is intended to use CEP 18/X/Y probe to detect alpha satellite sequences in the centromere regions of chromosomes 18, X, and Y, and LSI 13/21 probe to detect the 13g14 region and the 21q22.13 to 21q22.2 region. The Aneu Vysion™ kit is indicated for use as an adjunct to standard cytogenetic metaphase analysis for identifying and enumerating chromosomes 13, 18, 21, X, and Y via fluorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei obtained from amniotic fluid in subjects with presumed high risk pregnancies. It is not intended to be used as a stand alone assay for test reporting. FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, utilizing the same patient specimen. FISH results should not be reported prior to standard cytogenetic results except in instances where reporting of FISH results alone is medically indicated or standard cytogenetic results are not available, e.g., culture failure. Reporting and interpretation of FISH should be consistent with professional standards of practice! This device is intended for use only with amniocyte cells; it is not intended for and has not been validated for use with other test matrices. This FISH assay will not detect the presence of structural chromosome abnormalities frequently associated with birth defects. This FISH assay will be performed in cytogenetics laboratories.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
This FISH assay will be performed in cytogenetics laboratories.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
A pivotal study was conducted to assess the reproducibility of the AneuVysion™ assay interphase analysis for the percentage of aneuploid cells. The Aneu Vysion™ assay were assessed for inter-site, inter-lot, inter-day and inter-observer reproducibility. One normal and three mosaic cultured human amniocyte specimens were evaluated for the percentage of aneuploid cells according to the instructions for signal enumeration in the package insert. Using ANOVA, no significant variations were observed in any of the inter-assay reproducibility parameters. N=24 for 100% XY, 10% X/90% XX, 17% X/47% XX/36% XXX, and 50% XY+21/50% XY.
A multi-center, blinded, controlled, comparative study was conducted to further define A multi-center, onnoon, contronou, ochipe in relative to standard cytogenetic analysis, the standard of care, in cultured and uncultured amniotic fluid speciments. Thirty one investigation sites analyzed amniotic fluid specimens obtained from a total of 1516 patients. All study sites conducted the trial according to the prescribed assay procedures and signal enumeration guides. A total of 2,238 amniocyte specimens were obtained and analyzed from 1,516 patients. Of these 2,238 specimens, 55 were deemed uninformative. These 55 uninformative specimens included three due to maternal cell contamination, four due to FISH assay specificals included unce date to machine (c40) number of nucles for analysis. Thus on per specimen basis, the rate of informativeness is 97.5% (2183/2238). Note that among the Specifich basis, the rate of insufficient (
§ 866.4700 Automated fluorescence
in situ hybridization (FISH) enumeration systems.(a)
Identification. An automated FISH enumeration system is a device that consists of an automated scanning microscope, image analysis system, and customized software applications for FISH assays. This device is intended for in vitro diagnostic use with FISH assays as an aid in the detection, counting and classification of cells based on recognition of cellular color, size, and shape, and in the detection and enumeration of FISH signals in interphase nuclei of formalin-fixed, paraffin-embedded human tissue specimens.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Automated Fluorescencein situ Hybridization (FISH) Enumeration Systems.” See § 866.1(e) for the availability of this guidance document.
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SUMMARY: SAFETY AND EFFECTIVENESS INFORMATION FOR AneuVysion™ kit
The AneuVysion™ kit is a combination of two DNA probe mixtures; CEP 18/X/Y and LSI 13/21. The CEP 18/X/Y probe is a mixture of directly labeled fluorescent DNA probes specific for the D18Z1, DXZ1 and DYZ3 regions of chromosomes 18, X, and Y respectively. The LSI 13/21 probe contains a mixture of unique DNA sequences that hybridize in the 13q14 region of chromosome 13, and unique DNA sequences complementary to the D21S259, D21S341, and D21S342 loci contained within the 21q22.13 to 21q22.2 region on the long arm of chromosome 21. The LSI 13 probe was created from a set of overlapping clones which contain the entire RB-1 gene as well as regions extending beyond the gene on both sides. The probe extends beyond the 180 kb RB-1 gene for 110-170 kb in the 5' direction and approximately 120 kb in the 3' direction; the entire probe is 410-470 kb. CEP 18/X/Y is an aqua, green, and orange tri-color probe mixture and LSI 13/21 is a green and orange dual-color probe mixture.
The Aneu Vysion™ (CEP 18, X, Y-alpha satellite, LSI 13 and 21) Multicolor Probe Panel is intended to use CEP 18/X/Y probe to detect alpha satellite sequences in the centromere regions of chromosomes 18, X, and Y, and LSI 13/21 probe to detect the 13g14 region and the 21q22.13 to 21q22.2 region. The Aneu Vysion™ kit is indicated for use as an adjunct to standard cytogenetic metaphase analysis for identifying and enumerating chromosomes 13, 18, 21, X, and Y via fluorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei obtained from amniotic fluid in subjects with presumed high risk pregnancies. It is not intended to be used as a stand alone assay for test reporting. FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, utilizing the same patient specimen. FISH results should not be reported prior to standard cytogenetic results except in instances where reporting of FISH results alone is medically indicated or standard cytogenetic results are not available, e.g., culture failure. Reporting and interpretation of FISH should be consistent with professional standards of practice! This device is intended for use only with amniocyte cells; it is not intended for and has not been validated for use with other test matrices. This FISH assay will not detect the presence of structural chromosome abnormalities frequently associated with birth defects. This FISH assay will be performed in cytogenetics laboratories.
Standard cytogenetic analysis detects cytogenetic abnormalities by karyotyping metaphase spreads after staining the chromosomes with a dye in cultured tissue cells.
Safety and effectiveness issues relevant to FISH assays such as the AneuVysion™ assay may include cross-reactivity, poor sensitivity, poor specificity, or poor reproducibility.
1 American College of Medical Genetics. Prenatal interphase fluorescence in situ hybridization (FISH) policy statement. Am J Hum Genet. 1993;53:526-527.
1
Analytical Sensitivity and Specificity
Hybridization Efficiency
In the pivotal study, among the human amniotic fluid specimens, the average percentage of cells with no hybridization signal was 0.42% for LSI 13, CEP 18, and LST 21. The average percentage of cells with only one hybridization Y signal was 0.06% for CEP X/Y. Thus,