OVA — Complete Gene Expression Profiling Accessory Reagents Class II

FDA Device Classification

Classification Details

Product Code
OVA
Device Class
Class II
Regulation Number
862.2570
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K103112affymetrixAFFYMETRIX GENE PROFILING REAGENTSMay 4, 2011