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.
Inherited Nucleotide Repeat Disorder Dna Test
Immunology
The Inherited Nucleotide Repeat Disorder DNA Test is a prescription in vitro diagnostic test designed to detect and identify the number of nucleotide repeats in a gene using genomic DNA isolated from post-natal patient specimens, intended as an aid for carrier testing and diagnosis of inherited nucleotide repeat-associated disorders (such as Huntington's disease or fragile X syndrome), to be used in conjunction with other clinical and diagnostic findings. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OYV, with regulation number 866.5970 under the Immunology specialty, reviewed by the pathology panel.
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.