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.
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Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
Unknown
The Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 (product code PLS) is a Class 3 in vitro diagnostic device using a qualitative immunohistochemical antibody to identify PD-L1 protein expression in human clinical tissue specimens. Class 3 devices require Premarket Approval (PMA). The assay aids in identifying patients eligible for treatment with specific FDA-approved therapeutic drugs or in assessing PD-L1 expression levels in patients who may respond particularly well to such therapies. No regulation number is assigned.
No 510(k) clearances found for "PLS". Try a different K-number, product code, or device name.
What 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.