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U.S. Department of Health and Human Services

Product Classification

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Device complete gene expression profiling accessory reagents
Regulation Description Instrumentation for clinical multiplex test systems.
Definition Complete gene expression profiling accessory reagent kits include all components necessary to perform transcript synthesis, fluorescent labeling, and detection and are intended to carry out all processing steps for separately cleared gene expression microarray assays which specify their use. They are designed and optimized for preparation of labeled complementary RNA (cRNA) target using total RNA isolated from specific clinical tissue specimens for hybridization to and measurement of fluorescently-labeled cRNA targets using a specified and cleared microarray instrumentation system. They may also include specified exogenous controls intended to monitor amplification and labeling processes.
Physical State Should not include reagents to perform only part of gene expression assay processing steps (e.g., transcript synthesis but not labeling) or only individual components insufficient to carry out all processing steps or only RNA extraction and purification from specific clinical specimens. Should also not include reagents not intended for gene expression analysis, uncleared microarrays for gene expression, or cleared microarrays not specifying the reagent¿s use.
Technical Method Complete accessory reagents for gene expression profiling are intended, designed, and optimized to carry out all assay processes. The reagents include all components, including enzyme mixes, labeling reagents, reaction buffers, and purification reagents for the preparation, amplification, and specific labeling of cRNA targets from purified total RNA, isolated from specific tissue specimens, and the fragmentation and hybridization of the labeled-cRNA to microarrays for cleared microarray expression assays which specify their use.
Target Area Not applicable.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeOVA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(K) Exempt
Regulation Number 862.2570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible