510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
Free to try · every answer cites its records
Complete Gene Expression Profiling Accessory Reagents
Clinical Chemistry
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.
510(k) Clearances
1 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.