Complete Gene Expression Profiling Accessory Reagents
The Complete Gene Expression Profiling Accessory Reagents (product code OVA) are reagent kits that include all components necessary for transcript synthesis, fluorescent labeling, and detection used in conjunction with separately cleared gene expression microarray assays. They prepare labeled complementary RNA (cRNA) targets from total RNA isolated from clinical tissue specimens for hybridization to cleared microarray instrumentation systems, and may include exogenous controls to monitor amplification and labeling processes. As an FDA Class 2 device under regulation 862.2570, it requires 510(k) premarket clearance and falls within the Clinical Chemistry specialty. The device is not an implant and is not life-sustaining.
Research product code OVA in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OVA
- Device Class
- FDA class 2
- Regulation Number
- 862.2570
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K103112 | AFFYMETRIX GENE PROFILING REAGENTS | May 04, 2011 | Substantially Equivalent | Affymetrix, Inc. |