FDA product code OVA: Complete Gene Expression Profiling Accessory Reagents
OVA is the FDA product code for complete gene expression profiling accessory reagents. It is a Class II device, regulated under 21 CFR 862.2570 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under OVA. The average 510(k) review took 195 days (median 195).
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.
Classification
| Field | Value |
|---|---|
| Device name | Complete Gene Expression Profiling Accessory Reagents |
| Device class | Class II |
| Regulation | 21 CFR 862.2570 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every OVA clearance
Top OVA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Affymetrix, Inc. | 1 | 2011-05-04 |
Most recent OVA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K103112 | Affymetrix, Inc. | AFFYMETRIX GENE PROFILING REAGENTS | 2011-05-04 | 195 |
Recalls for OVA devices
openFDA lists no recalls for product code OVA.
Frequently asked questions
What is FDA product code OVA?
OVA is the FDA product code for complete gene expression profiling accessory reagents. It is a Class II device, regulated under 21 CFR 862.2570 and reviewed by the Clinical Chemistry panel.
What device class is OVA?
Class II, regulation 21 CFR 862.2570. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code OVA?
Across 1 cleared submissions the average was 195 days from receipt to decision (median 195).
Which companies have the most OVA clearances?
Affymetrix, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OVA
- Run a recall and safety report across every OVA manufacturer
- Watch product code OVA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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